Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Standard method, GLP-compliant, adequate experimental details for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.31 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
light brown liquid

Test animals

Species:
rat
Strain:
other: COBS CD (SD) BR

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure (if applicable):
whole body
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
Females were paired with male (sexually mature) of same strain after 13 days acclimation period. Females examined for copulatory plug daily. Presence of a plug indicated evidence of mating (gestation Day 0)
Duration of treatment / exposure:
Gestation Day 6 to 15
6 hours per day
Frequency of treatment:
once per day (6h)
Duration of test:
20 days (10days of exposure)
No. of animals per sex per dose:
20 female: 0 ppm
20 female: 100 ppm (nominal)
20 female: 400 ppm (nominal)
Control animals:
yes

Examinations

Maternal examinations:
Body weight, food consumption
general appearance, behaviour and condition
Pathology: thoraric and visceral organs were examined
Ovaries and uterine content:
Uteruses were removed from each rat and opened. The live and dead foetuses, implantation site and placement in the uterine horns and resorption sites were recorded
Fetal examinations:
Examined externally and weighed
Two-thirds of foetuses of each litter were examined for skeletal abnormalities
Remaining foetuses of each litter were prepared by fixing in Bouin's fuild for later examination looking for changes in the soft tissues of visceral and thoracic organs and the head

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:
NOAEC
Effect level:
401.5 ppm (analytical)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:
NOAEC
Effect level:
401.5 ppm (analytical)
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on the results of this study on the analogous substance, Renewable Diesel is not expected to affect foetal development
Executive summary:

Based on the results of this study on the analogous substance, Renewable Diesel is not expected to affect foetal development