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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is a well-documented study report that follows basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
exposed prior to mating and through to day 20
Principles of method if other than guideline:
Female rats were administered test compound beginning 7 days prior to mating and continued through mating, and to gestation day 20. Dams were examined for general health and toxicity. Pups were examined for gross abnormalities at birth and body weights recorded on day 0 and 4. Pups were also sexed and observed for survival through day 4.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity hydrocarbon liquid
Details on test material:
- Name of test material (as cited in study report): F-277, light coker gas oil
- Substance type: Cracked gas oil
- Light brown to orange-coloured viscous liquid with a slightly cracked or burnt to asphaltic odour
- Flash Pt (approx °F): >150
- Specific gravity (approx): 0.89-0.95
- Purity petroleum distillates
- Stability: stable
- Volatility: slight
- Storage conditions (°F): 80 or below
- Boiling Pt range (°F): 320-1100

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
dermal
Vehicle:
unchanged (no vehicle)
Details on mating procedure:
presumed-pregnant females
Duration of treatment / exposure:
6 hours
Frequency of treatment:
once daily
Duration of test:
Treated for one week prior to mating through day 20 of gestation
Doses / concentrations
Remarks:
Doses / Concentrations:
1, 50, 250 mg/kg
Basis:

No. of animals per sex per dose:
12 females per treatment dose, 15 female sham controls
Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Dermal irritation at doses of 1, 50, and 250 mg/kg; increased absolute and relative food consumption at 50 mg/kg; decreased body weight, absolute food consumption during premating, increased relative food consumption during gestation, and increased absolute amd relative food consumption during lactation at 250 mg/kg.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOEL
Effect level:
1 mg/kg bw/day
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Decreased pup body weight on lactation days 0 and 4 in the 250 mg/kg dose group.

Effect levels (fetuses)

Remarks on result:
other: see Details on embyotoxic/teratogenic effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOEL for maternal toxicity is 1 mg/kg/day. The NOEL for developmental toxicity is 50 mg/kg/day.
Executive summary:

In a developmental toxicity study, presumed-pregnant Sprague-Dawley females (12/dose, 15 in sham control group) were dermally exposed to light coker gas oil for six hour of exposure at dose levels of 1, 50, or 250 mg/kg/day once daily at seven days before gestation through day 20 of gestation.

Maternal toxicity included dermal irritation at doses of 1, 50, and 250 mg/kg; increased absolute and relative food consumption at 50 mg/kg; decreased body weight, absolute food consumption during premating, increased relative food consumption during gestation, and increased absolute amd relative food consumption during lactation at 250 mg/kg. Decreased pup body weight on lactation days 0 and 4 in the 250 mg/kg dose group. Under conditions of the study, the NOEL for maternal toxicity is 1 mg/kg/day and for developmental toxicity the NOEL is 50 mg/kg/day.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is a well-documented study report that follows basic scientific principles.