Section 8(e) Substantial Risk Notifications and FYI Submissions Received September 2010
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|8EHQ-0910-18093A (PDF)||Vanadyl Sulfate (VOS04) (solid) (with hydration)||27774-13-6||Vanadium Producers & Reclaminers Association||Results from an acute inhalation toxicity study on an aqueous solution of vanadyl sulfate hydrate (CASRN 27774-13-6).|
|8EHQ-0910-18094A (PDF)||1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,10 a-octahydro-1 ,4a-dimethyl-7-(1-methylethyl)-, (1R,4aS,1 OaR)-||1740-19-8||Arizona Chemical Company||Results of two acute ecotoxicity studies (acute toxicity to Daphnia Magna and Pseudokirchneriella subcaptitata algal growth inhibition test) with 1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,1Oa-octahydro-1 ,4a-dimethyl-7-(1-methylethyl)-, (1R,4aS,1 OaR)- (CASRN 1740-19-8)|
|8EHQ-0910-18096A (PDF)||Polyethylene Glycol Hydrogen Maleate Isoalkyl Ethers||1231189-27-7||BASF||Results of a Local Lymph Node Assay (LLNA) with Fatty acids, tall oil, reaction products with pentaethylenehexamine, compounds with polyethylene glycol hydrogen maleate isoalkyl ethers (CASRN1231189-27-7).|
|8EHQ-0910-18100A (PDF)||Tert-butyl perbenzoate||614-45-9||Y||AkzoNobel||Results from a draft OECD 421 Reproduction/Developmental Toxicity Screening Test on tert-butyl perbenzoate (CASRN 61445-9).|
|8EHQ-0910-18101A (PDF)||Pentaerythritol||94581-15-4 AKA 65997-11-7||Arizona Chemical Company||A summary of an Oral (Gavage) Combined Repeat Dose Toxicity study with
reproduction/developmental toxicity screening test in the rat on pentaerythritol (CASRN 94581-15-4 known as CASRN
65997-11-7 in the US).
The effects mainly consisted of microscopic changes in the urinary bladder. As such, a 'No Observed Adverse Effect Level' (NOAEL) was established at 300 mg/kg/day for systemic toxicity. No treatment-related effects were detected for reproductive performance, hence a 'No Observed Effect Level' (NOEL) for reproductive toxicity was considered to be 1000 mg/kg/day.
|8EHQ-0910-18102A (PDF)||1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9, 10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-, sodium salt (1:1), (1R,4aS,10aR)-||28161-39-9||Arizona Chemical||A summary of a Bovine Corneal
Opacity and Permeability study in vitro
test on 1-Phenanthrenecarboxylic acid,
salt (1:1), (1R,4aS,10aR) (CASRN
28161-39-9 to measure potential for
eye irritation/corrosion. The summary
shows the material to be a severe eye
irritant and corrosive under the
conditions of the study.
The IVIS for test substance was 221.5. IVIS for the negative control was 0.9 and for the positive control 207.3 and for the negative benchmark control 0.9, thus demonstrating the validity of the experiment. The test substance is considered to be an ocular corrosive or severe irritant.
|8EHQ-0910-18103A (PDF)||Perfluorooctanoic Acid, Perfluorooctanesulfonate||Not Provided||Taft Stettinius and Hollister LLP||Perfluorooctanoic Acid, Perfluorooctanesulfonate, and
Serum Lipids in Children and Adolescents.
Although the epiderniologic and crosssectional natures of this study limit causal inferences, the consistentlyobserved associations between increasing PFOA and PFOS and elevated total cholesterol and LDLC levels warrant funher study.
|8EHQ-0910-18104A (PDF)||Styrene/Acrylic Polymer||Not Provided||Dow Chemical Company||Summary of an acute inhalation toxicity study in rats using styrene/acrylic polymer.|
|8EHQ-0910-18105A (PDF)||3-[[[5-[2-haloalkenyloxy]-1-alkyl-3-(trihaloalky1)-heteromonocyclic-4-yl]alkyl]sulfonyl]-dihydroheteromonocycle||Not Provided||Confidential||The results of an in
vitro mutagenicity assay with 3-[[[5-[2-haloalkenyloxy]-1-alkyl-3-(trihaloalky1)-heteromonocyclic-4-yl]alkyl]sulfonyl]-dihydroheteromonocycle.
The results of the Bacterial Reverse Mutation test indicate that, under the conditions of this study, the test substance was able to induce a mutagenic response in the presence of Aroclor-induced rat liver S9 only. The test substance was concluded to be positive in this study.
|8EHQ-0910-18106A (PDF)||Difluoromethane||75-10-5||DuPont Haskell Global Centers||An assessment of
anesthetic potency in mice by inhalation after exposue
todifluoromethane (CASRN 75-10-5).
No anesthetic effects or mortality resulted from exposure of up to 50% of the test substance for 10 minutes. The observations noted led to the conclusion that the EC50(10 minutes) for anesthetic potency was greater than 50%.
|8EHQ-0910-18107A (PDF)||Isodecyl Neopentanoate (> 60%) and Dimethyl, Methyhydrogen Siloxane with Polypropylene Glycol (10-30%)||60209-82-7 & 1043538-34-6||Dow Corning Corporation||Results of a Dermal
Sensitization Test in Guniea Pigs - Magnusson and Kligman (M&K)
Method after exposure to Isodecyl Neopentanoate (> 60%) and Dimethyl, Methyhydrogen Siloxane with Polypropylene Glycol (10-30%) (CASRNs 60209-82-7 and 1043538-34-6)
Based on these findings, Dow Corning® EL-8051 IN Silicone Organic Elastomer Blend was classified as a skin sensitizer.
|8EHQ-0910-18108A (PDF)||Two Mixtures||Multiple||Nalco Company||Results of acute toxicity testing on two mixtures in rats and rabbits using two mixtures: aliphatic hydrocarbon (CASRN 64742-47-8); propylene glycol (CASRN 57-55-6); 2-propanol, 1-(2-butoxy-l-methylethoxy)- (CASRN 29911-28-2); di(2-ethylhexyl) sodium sulfosuccinate (CASRN 577-11-7); ethoxylated sorbitan trioleate (CASRN 9005-70-3); ethoxylated sorbitan monooleate (CASRN 9005-65-6); sorbitan monooleate (CASRN 1338-43- 8); and water (CASRN 7732-18-5)
The mixture consisted of: 2- butoxyethyl alcohol (CASRN 111- 76- 2); propylene glycol (CASRN 57-55-6); di(2-ethylhexyl) sodium sulfosuccinate (CASRN 577-11-7); ethoxylated sorbitan trioleate (9005-70-3); ethoxylated sorbitan monooleate (CASRN 9005-65- 6); sorbitan monooleate (CASRN 1338-43-8); and water (CASRN 7732-18-5).
|8EHQ-0910-18109A (PDF)||N-ethylpyrrolidone-2||2687-91-4||BASF||Results of a 14-Day Inhalation Toxicity Study in Wistar Rats with N-ethylpyrrolidone-2 (CASRN 2687-91-4).|
|8EHQ-0910-18110A (PDF)||Citranaxanthin||3604-90-8||BASF||Results of a Repeated Dose 90-Day Oral Toxicity Study in Wistar Rats with Lucantin CX forte, Containing 11% Citranaxanthin (CASRN 3604-90-8).|
|8EHQ-0910-18111A (PDF)||Isophthalic Acid||121-91-5||DuPontHaskell Global Centers||Results of an acute
oral toxicity study in rats using isophthalic acid
The acute oral LD50 of isophthalic acid - 85 was calculated to be 10,900 mg/kg bw. The acute oral LD50 ofisophthalic acid - 110 was calculated to be 13,000 mg/kg. Necropsy examination of the rats that died revealed pale, discolored kidneys. Examination of the animals sacrificed at the end of the 14 day observation period did not reveal any gross pathologic alterations.
|8EHQ-0910-18112A (PDF)||'Dimer dilinoleamidopropyl dimethylamine, hydrogenated||138337-31-2||Lubrizol Corporation||Results describing the
findings of a Mouse Local Lymph Node Assay (LLNA) using the test material 'Dimer dilinoleamidopropyl dimethylamine, hydrogenated' (CAS# 138337-31-2); product name
The results of this study indicate the test material induced dermal sensitization response with an approximate LLNA EC3 of 0.25%.
|8EHQ-0910-18115A (PDF)||Confidential *2||Confidential||Confidential||results of an acute oral screeing study with the CBI substance in Crl:CD-1 mice|
|8EHQ-0910-18117A (PDF)||Huntsman ALBAFIXO ECO||Not Provided||Huntsman International LLC||Results of a direct systemic injection test (ISO-10993-11) using Huntsman ALBAFIXO ECO|
|8EHQ-0910-18118A (PDF)||PFOA||Not Provided||Taft Stettinius & Hollister LLP||Study Reporting the
Accumulation and Clearance of PFOA in Current and Former Residents of an
Years of residence in an exposed water district was positively associated with observed serum PFOA in 2005-2006. Differences in serum clearance rate between low- and high-exposure water districts suggest a possible concentration-dependent or timedependent clearance process, or inadequate adjustment for background exposures.
|8EHQ-0910-18121A (PDF)||Confidential *2||Confidential||Confidential||Results of a new toxicological effects in an acute oral toxicity study in rats with an experimental pyrethroid insecticide.|
|FYI-0910-01675A (PDF)||Perfluorooctanoic Acid, Perfluorooctanesulfonate||Not Provided||Taft Stettinius & Hollister LLP||Perfluorooctanoic Acid, Perfluorooctanesulfonate, and
Serum Lipids in Children and Adolescents.
Although the epiderniologic and crosssectional natures of this study limit causal inferences, the consistently observed associations between increasing PFOA and PFOS and elevated total cholesterol and LDLC levels warrant funher study.
|8EHQ-0910-17252B (PDF)||Confidential *2||Not Provided||Confidential||Results of the effects in a prerenatal & dvelopnrental toxicity study in rats.|
|8EHQ-0910-17540B (PDF)||amides, tall-oil fatty, N-[3-9dimethylaminol]propyl||68650-79-3||Bayer Material Science LLC||Summary of an Inherent biodegradability: Modified MITTI Test (II) of amides, tall-oil fatty, N-[3-9dimethylaminol]propyl (CASRN 68650-79-3).|
|8EHQ-0910-17616B (PDF)||amides, tall-oil fatty, N-[3-9dimethylaminol]propyl||68650-79-3||Bayer Material Science LLC||Summary of an Inherent biodegradability: Modified MITTI Test (II) of amides, tall-oil fatty, N-[3-9dimethylaminol]propyl (CASRN 68650-79-3).|
|8EHQ-0910-17890B (PDF)||3,3,3-trifluoroprop-1-ene||677-21-4||Mexichem Fluor Inc.||Withdrawal of Confidentiality Clam For 8EHQ-10-17890|
|8EHQ-0910-17915B (PDF)||Terephithalic Acid||100-21-0||DuPont Haskell Global Centers||The results of a mouse micronucleus test and an invitro cytogenetic assay in human lymphocytes study using terephithalic acid (CASRN 100-21-0).|
|8EHQ-0910-17928B (PDF)||amides, tall-oil fatty, N-13- 9dimethylaminolpropyl||68650-79-3||Bayer Material Science LLC||Summary of an Inherent biodegradability: Modified MITTI Test (II) of amides, tall-oil fatty, N-[3-9dimethylaminol]propyl (CASRN 68650-79-3).|
|8EHQ-0910-18079B (PDF)||Fluorinated Acrylic Copolymer in an Organic Solvent||Not Provided||Confidential||The results of a skin
irritation study in rabbits with fluorinated acrylic copolymer in an organic
Hyperkeratosis was observed on the test site of all 3 rabbits at 72 hours and on the test site of one rabbit at days 7 and 10. Desquamation persisted in 2 rabbits through study termination (day 14).
|8EHQ-0910-18085B (PDF)||Confidential||Confidential||Confidential||Results of a repeated dose 28-day oral toxicity study with the CBI substance by daily gavage in the rat followed by a 14-day recovery period.|
(A) PMN; (B) Pesticide; (C) Pesticide Inert
DEFINITION OF TERMS
8EHQ# - This is the EPA submission number that includes a 4-digit month and year followed by a 5-digit number assigned sequentially from the year 1977, followed by a sequence letter ( “A” for the initial submission and “B”, “C”, “D”, etc. for supplemental submissions) (8EHQ-MMYY-XXXXX A).
Supplemental means that it is a follow-up to an earlier submitted report. Supplemental submissions reflect the month and year logged in but retain the same 5-digit sequential number as a link to the initial submission. 8EHQ number is a useful reference to request a copy of a submission.FYI (For Your Information) submissions are the voluntary adjuncts of 8(e)s. The FYI# is similar to that for 8(e) described above (FYI-MMYY-XXXXX A). The submitter either judges that the information is not reportable under TSCA 8(e) reporting requirements or is not subject to TSCA 8(e) reporting but wants to share the information with EPA (and the public) on a voluntary basis.
NOTE that OPPT routinely sends follow-up requests to 8(e) submitters. Other EPA programs and other federal agencies can ask OPPT to request follow-up information as well.
CHEM Name - This is the name used by the submitter.
CAS No. - The Chemical Abstracts Service Number. Use of the term "CBI" indicates that the submitter is claiming the identity of the chemical to be confidential business information. This claim can be challenged in some cases, and users should notify EPA if they wish to pursue the chemical identity.
USHV - High production volume chemical in the U.S., including domestic manufacture and importation. EPA defines high production volume as annual production one million pounds or more pounds.
Description - A general description of the type of study or information submitted, but not study results. A PDF electronic copy of the submission is attached.