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Chloramben (CASRN 133-90-4)

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Chloramben; CASRN 133-90-4

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 Chloramben

File First On-Line 01/31/1987

Category (section)
Status
Last Revised
Oral RfD Assessment (I.A.) on-line 03/01/1988
Inhalation RfC Assessment (I.B.) no data 09/01/1992
Carcinogenicity Assessment (II.) no data

_I.  Chronic Health Hazard Assessments for Noncarcinogenic Effects

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

Substance Name — Chloramben
CASRN — 133-90-4
Last Revised — 03/01/1988

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
Hepatocyte
degeneration

18-Month Feeding
Study in CD-1 Mice

Union Carbide, 1978

NOEL: none

LEL: 100 ppm diet
(15 mg/kg/day)

1000
1
1.5E-2
mg/kg/day

*Conversion Factors -- 1 ppm = 0.15 mg/kg/day (assumed mouse food consumption)

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

Union Carbide Agricultural Products Company, Inc. 1978. MRID No. 00040392, 00040398. Available from EPA. Write for FOI, EPA, Washington DC 20460.

Five hundred (250 male and 250 female) Crl:COBS CD-1 mice (approximately 4 weeks of age) were assigned 50/sex/group, to one control and three test groups. The test groups were fed diets containing the following levels of chloramben: 100, 1000, and 10,000 ppm. All animals were observed once a day for signs of illness or toxicity. All animals found dead or in extremis were subjected to gross necropsy examination. After 18 months, surviving animals were sacrificed. Nonneoplastic lesions were mainly observed in the liver and included hepatocyte degeneration.

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

UF — An uncertainty factor of 100 was used to account for the inter- and intra-species differences. An additional UF of 10 was used to account for the fact that a NOEL was not established.

MF — None

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

Data Considered for Establishing the RfD

  1. 18-Month Oncogenic (dietary) - Principal study - see description above; core grade supplementary
  2. Teratology - rat: Fetotoxic NOEL=500 ppm (25 mg/kg/day); Fetotoxic LEL=1500 ppm (75 mg/kg/day) (reduced ossification of skeletal bones); Maternal and Teratogenic NOEL=4500 ppm (HDT); core grade minimum (Union Carbide, 1976)
  3. 2-Year Feeding - rat: Systemic NOEL=1000 ppm (50 mg/kg/day); no core grade (Union Carbide, 1963a)
  4. 2-Year Feeding - dog: Systemic NOEL=10,000 ppm (250 mg/kg/day) (HDT); no core grade (Union Carbide, 1963b)
  5. 3-Generation Reproduction - rat: Systemic NOEL=4500 ppm (225 mg/kg/day) (HDT); Reproductive NOEL=4500 ppm (HDT); no core grade (Union Carbide, 1966)

Data Gap(s): Rabbit Teratology Study

Other Data Reviewed

1) 80-Week Oncogenic - mice: Systemic NOEL=20,000 ppm (300 mg/kg/day); core grade supplementary (NCI, 1977)

__I.A.5. Confidence in the Oral RfD

Study — Medium
Database — Medium
RfD — Medium

The principal study appears to be of acceptable quality and is given a medium confidence rating. Since there is a data gap existing for chloramben and other studies do not show effects at much higher dose levels, confidence in the database can be considered medium to low. Confidence in the RfD can also be considered medium to low.

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

Pesticide Registration Standard, July 1981

Pesticide Registration Files

Agency Work Group Review — 06/24/1986

Verification Date — 06/24/1986

Screening-Level Literature Review Findings — A screening-level review conducted by an EPA contractor of the more recent toxicology literature pertinent to the RfD for Chloramben conducted in August 2003 did not identify any critical new studies. IRIS users who know of important new studies may provide that information to the IRIS Hotline at hotline.iris@epa.gov or 202-566-1676.

__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 — Chloramben
CASRN — 133-90-4

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Chloramben
CASRN — 133-90-4

Not available at this time.

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


_VI.  Bibliography

Substance Name — Chloramben
CASRN — 133-90-4
Last Revised — 11/01/1989

_VI.A. Oral RfD References

NCI (National Cancer Institute). 1977. Bioassay of chloramben for possible carcinogenicity. U.S. DHEW Pub. No. (NIH) 77-825, Bethesda, MD.

Union Carbide Agricultural Products Company, Inc. 1963a. MRID No. 00100200, 00104543, 00104548. Available from EPA. Write for FOI, EPA, Washington DC 20460.

Union Carbide Agricultural Products Company, Inc. 1963b. MRID No. 00100201, 00139708. Available from EPA. Write for FOI, EPA, Washington DC 20460.

Union Carbide Agricultural Products Company, Inc. 1966. MRID No. 00100202. Available from EPA. Write for FOI, EPA, Washington DC 20460.

Union Carbide Agricultural Products Company, Inc. 1976. MRID No. 00096618. Available from EPA. Write for FOI, EPA, Washington DC 20460.

Union Carbide Agricultural Products Company, Inc. 1978. MRID No. 00040392, 00040398. Available from EPA. Write for 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 — Chloramben
CASRN — 133-90-4

Date
Section
Description
03/31/1987 IV. Regulatory Action Section on-line
03/01/1988 I.A.5. Confidence levels revised
11/01/1989 VI. Bibliography on-line
01/01/1992 IV. Regulatory action updated
09/01/1992 I.B. Inhalation RfC now under review
08/01/1995 I.B. EPA's RfD/RfC and CRAVE workgroups were discontinued in May, 1995. Chemical substance reviews that were not completed by September 1995 were taken out of IRIS review. The IRIS Pilot Program replaced the workgroup functions beginning in September, 1995.
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.
10/28/2003 I.A.6. Screening-Level Literature Review Findings message has been added.

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_VIII.  Synonyms

Substance Name — Chloramben
CASRN — 133-90-4
Last Revised — 01/31/1987

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