Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
other:
Adequacy of study:
supporting study
Study period:
2012
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Short description on comprehensive studies available via the internet by US EPA and pubchem.ncbi.nlm.nih.gov
Principles of method if other than guideline:
No data
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: feed
Vehicle:
not specified
Details on mating procedure:
no data
Duration of treatment / exposure:
no data
Frequency of treatment:
daily
Details on study schedule:
no data
No. of animals per sex per dose:
no data
Reproductive effects observed:
not specified

2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen);

Executive summary:

Executive summary is derived from the following internet links on 2012 -11 -09.

http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=62276#x321

http://www.epa.gov/iris/subst/0280.htm

References of individual studies:

PPG Industries. 1983a. MRID No. 00132885. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

PPG Industries. 1982b. MRID No. 00117566. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

PPG Industries. 1985c. MRID No. 00150367, 00163307. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen); core grade minimum (PPG Industries, 1983a)

Teratology - rat: Fetotoxic NOEL=50 mg/kg/day; Fetotoxic LEL=150 mg/kg (bent ribs); Teratogenic NOEL=150 mg/kg/day; Maternal NOEL=50 mg/kg/day; Maternal LEL=150 mg/kg/day (post implantation loss; reduced body weight); core grade minimum (PPG Industries, 1982b)

Teratology - rabbit: Maternal NOEL=4 mg/kg/day; Maternal LEL=20 mg/kg/day (decreased food consumption); Fetotoxic NOEL=20 mg/kg/day; core grade minimum (PPG Industries, 1985c)

Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen); core grade minimum (PPG Industries, 1983a)

Effects on developmental toxicity

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
other:
Adequacy of study:
supporting study
Study period:
2012
Rationale for reliability incl. deficiencies:
other: Short description on comprehensive studies available via the internet by US EPA and pubchem.ncbi.nlm.nih.gov
Principles of method if other than guideline:
Teratology studies; no further data
Species:
other: rabbits and rats
Strain:
not specified
Vehicle:
not specified
Details on mating procedure:
No data
Duration of treatment / exposure:
No data
Frequency of treatment:
daily
Duration of test:
no data
No. of animals per sex per dose:
no data
Abnormalities:
not specified
Developmental effects observed:
not specified
Executive summary:

Executive summary is derived from the following internet links on 2012 -11 -09.

http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=62276#x321

http://www.epa.gov/iris/subst/0280.htm

References of individual studies:

PPG Industries. 1983a. MRID No. 00132885. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

PPG Industries. 1982b. MRID No. 00117566. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

PPG Industries. 1985c. MRID No. 00150367, 00163307. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen); core grade minimum (PPG Industries, 1983a)

Teratology - rat: Fetotoxic NOEL=50 mg/kg/day; Fetotoxic LEL=150 mg/kg (bent ribs); Teratogenic NOEL=150 mg/kg/day; Maternal NOEL=50 mg/kg/day; Maternal LEL=150 mg/kg/day (post implantation loss; reduced body weight); core grade minimum (PPG Industries, 1982b)

Teratology - rabbit: Maternal NOEL=4 mg/kg/day; Maternal LEL=20 mg/kg/day (decreased food consumption); Fetotoxic NOEL=20 mg/kg/day; core grade minimum (PPG Industries, 1985c)

Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Teratology - rat: Fetotoxic NOEL=50 mg/kg/day; Fetotoxic LEL=150 mg/kg (bent ribs); Teratogenic NOEL=150 mg/kg/day; Maternal NOEL=50 mg/kg/day; Maternal LEL=150 mg/kg/day (post implantation loss; reduced body weight); core grade minimum (PPG Industries, 1982b)

Teratology - rabbit: Maternal NOEL=4 mg/kg/day; Maternal LEL=20 mg/kg/day (decreased food consumption); Fetotoxic NOEL=20 mg/kg/day; core grade minimum (PPG Industries, 1985c)

Justification for classification or non-classification