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Triallate (CASRN 2303-17-5)

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0195

Triallate; CASRN 2303-17-5

Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data, as outlined in the IRIS assessment development process. Sections I (Health Hazard Assessments for Noncarcinogenic Effects) and II (Carcinogenicity Assessment for Lifetime Exposure) present the conclusions that were reached during the assessment development process. Supporting information and explanations of the methods used to derive the values given in IRIS are provided in the guidance documents located on the IRIS website.

STATUS OF DATA FOR Triallate

File First On-Line 03/31/1987

Category (section)
Status
Last Revised
Oral RfD Assessment (I.A.) on-line 01/01/1992
Inhalation RfC Assessment (I.B.) no data
Carcinogenicity Assessment (II.) no data

_I.  Chronic Health Hazard Assessments for Noncarcinogenic Effects

_I.A. Reference Dose for Chronic Oral Exposure (RfD)

Substance Name — Triallate
CASRN — 2303-17-5
Last Revised — 01/01/1992

The oral Reference Dose (RfD) is based on the assumption that thresholds exist for certain toxic effects such as cellular necrosis. It is expressed in units of mg/kg-day. In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. Please refer to the Background Document for an elaboration of these concepts. RfDs can also be derived for the noncarcinogenic health effects of substances that are also carcinogens. Therefore, it is essential to refer to other sources of information concerning the carcinogenicity of this substance. If the U.S. EPA has evaluated this substance for potential human carcinogenicity, a summary of that evaluation will be contained in Section II of this file.

__I.A.1. Oral RfD Summary

Critical Effect
Experimental Doses*
UF
MF
RfD

Increased hemosiderin
deposition, serum
alkaline phosphatase,
and liver weight in
females

2-Year Dog Feeding
Study

Monsanto, 1979

NOAEL: 1.275 mg/kg/day

LOAEL: 4.25 mg/kg/day

100
1
1.3E-2
mg/kg/day

*Conversion Factors: see text

__I.A.2. Principal and Supporting Studies (Oral RfD)

Monsanto Company. 1979. MRID No. 00029455; HED Doc. No. 005525. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Four beagle dogs/sex/group were fed 0, 1.5, 5 and 15 mg/kg triallate ad libitum for 24 months. At the end of the study, animals were sacrificed and necropsied. An increase in liver weight in the high-dose group of males and mid-dose group of females was observed. An increase in hemosiderin deposition, particularly in the spleen, was noted in all triallate-treated groups, and an increase in serum alkaline phosphatase levels was observed in the mid-dose and high-dose groups. The effect of increased hemosiderin deposition at the low dose was slight to minimal; at higher doses there were no effects related to the hematopoietic system. The amount of triallate in the diets was calculated to be 1.275 mg/kg/day, 4.25\mg/kg/day, and 12.75 mg/kg/day as a result of dogs receiving, on the average, 85% of the targeted doses in their diets.

__I.A.3. Uncertainty and Modifying Factors (Oral RfD)

UF — An uncertainty factor of 100 was used to account for inter- and intraspecies differences.

MF — None

__I.A.4. Additional Studies/Comments (Oral RfD)

None

Data Considered for Establishing the RfD:

1) 2-Year Feeding - dog: Principal study - see previous description; core grade minimum

2) 2-Year Feeding - mouse: NOEL=20 ppm (3 mg/kg/day); LEL=60 ppm (9 mg/kg/day) (increased splenic hematopoiesis for males); core grade minimum (Monsanto Co., 1983)

3) Chronic Feeding - hamster: NOEL=50 ppm (5 mg/kg/day); LEL=300 ppm (30 mg/kg/day) (decreased triglycerides in males); core grade supplementary (urinalyses and clotting measurements were reported) (Monsanto Co., 1984a)

4) 2-Generation Reproduction - rat: Tentative NOEL=150 ppm (7.5 mg/kg/day); Tentative LEL=600 ppm (30 mg/kg/day) (head bobbing and circling in pregnant females, reduced mean pup weight at birth); core grade minimum (Monsanto Co., 1984b)

5) Teratology - rat: Maternal and Fetotoxic NOEL=30 mg/kg/day; Maternal and Fetotoxic LEL=90 mg/kg/day (reduced weight and reduced ossification); core grade minimum (Monsanto Co., 1982a)

6) Teratology - rabbit: Fetotoxic NOEL=5 mg/kg/day; Fetotoxic LEL=15 mg/kg/day (unossified sternabrae and an increase in skeletal malformations); core grade minimum (Monsanto Co., 1982b)

Data Gap(s): Chronic Rat Feeding Study

__I.A.5. Confidence in the Oral RfD

Study — Medium
Database — High
RfD — High

The critical study is of adequate quality and is given a medium confidence rating. The database on chronic toxicity is supportive; therefore, confidence in the database can be considered high to medium. Confidence in the RfD can also be considered high to medium.

__I.A.6. EPA Documentation and Review of the Oral RfD

Pesticide Registration Files

Agency Work Group Review — 12/16/1986

Verification Date — 12/16/1986

__I.A.7. EPA Contacts (Oral RfD)

Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202)566-1676 (phone), (202)566-1749 (FAX) or hotline.iris@epa.gov (internet address).

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_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)

Substance Name — Triallate
CASRN — 2303-17-5

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Triallate
CASRN — 2303-17-5

This substance/agent has not undergone a complete evaluation and determination under US EPA's IRIS program for evidence of human carcinogenic potential.

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_III.  [reserved]
_IV.  [reserved]
_V.  [reserved]


_VI.  Bibliography

Substance Name — Triallate
CASRN — 2303-17-5
Last Revised — 01/01/1992

_VI.A. Oral RfD References

Monsanto Company. 1979. MRID No. 00029455; HED Doc. No. 005525. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Monsanto Company. 1982a. MRID No. 00114260, 92187021; HED Doc. No. 002996, 003651. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Monsanto Company. 1982b. MRID No. 00114261, 92187022; HED Doc. No. 002996. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Monsanto Company. 1983. MRID No. 00132859, 92187020; HED Doc. No. 004942, 006996. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Monsanto Company. 1984a. MRID No. 00132881, 00151790, 00159797, 00163574, 92187052; HED Doc. No. 006996, 007279. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Monsanto Company. 1984b. MRID No. 00132880, 00144308, 92187023; HED Doc. No. 004942, 005735. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

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_VI.B. Inhalation RfC References

None

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_VI.C. Carcinogenicity Assessment References

None

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_VII.  Revision History

Substance Name — Triallate
CASRN — 2303-17-5

Date
Section
Description
03/01/1988 I.A.5. Confidence levels revised
08/01/1990 I.A.1. RfD exponent corrected
01/01/1992 I.A.4. Citations added
01/01/1992 IV. Regulatory Action section on-line
01/01/1992 VI. Bibliography on-line
04/01/1997 III., IV., V. Drinking Water Health Advisories, EPA Regulatory Actions, and Supplementary Data were removed from IRIS on or before April 1997. IRIS users were directed to the appropriate EPA Program Offices for this information.
02/22/2001 I.A., II. This chemical is being reassessed under the IRIS Program.
02/09/2004 I.A., II. This chemical is no longer being reassessed under the IRIS Program. See Federal Register February 9, 2004 (Volume 69, Number 26).

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_VIII.  Synonyms

Substance Name — Triallate
CASRN — 2303-17-5
Last Revised — 03/31/1987

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