Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

There is no substance specific data available for Hydrocarbon, C4, 1,3-butadiene-free, polymd,, triisobutylylene fraction, hydrogenated. However, an OECD Guideline 422 screening reproductive/developmental toxicity study (oral route) in rodents is planned with structural analogue Hydrocarbons, C13-C16, isoalkanes, <2% aromatics (EC# 946-885-5).

Additionally, in order to comply with standard information requirements for Annex X substances, OECD 443 tests are proposed for structural analogues, Hydrocarbons, C7-C9, isoalkanes, <2% aromatics (EC# 921-728-3) and Isohexadecane (2,2,4,4,6,8,8-heptamethylnonane (EC# 224-506-8)). The testing proposals have been presented in the lead registrant dossiers for these substances already submitted to ECHA. This read across is based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in Section 13.2 of the dossier. The endpoint will be updated subsequent to ECHA's approval of the testing proposals and availability of data upon completion of the studies.

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - with developmental neurotoxicity (Cohorts 1A, 1B without extension, 2A and 2B)
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
The 'Justification for the read across' is provided in the 'Attached justification' section below.
Species:
rat

Effects on developmental toxicity

Description of key information

There is no data available for Hydrocarbon, C4, 1,3-butadiene-free, polymd,, triisobutylylene fraction, hydrogenated. However, data is available for structural analogues, Hydrocarbons, C7-C9, isoalkanes and Hydrocarbons, C10-C12, isoalkanes, <2% aromatics. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Hydrocarbons C7-C9, isoalkanes, <2% aromatics

A Segment II teratology study on hydrocarbons, C7-C9, isoalkanes, showed no evidence of embryonic or teratogenic effects in rats (ExxonMobil Chemical,1979). In this study, pregnant rats were exposed to 0, 400, or 1200 ppm for 6 h/day during gestational days 6 to 15. There was no mortality and no treatment-related effects to the dams. No treatment-related effects were observed in the number of live foetuses, foetal size, sex distribution, and external soft-tissue or skeletal examinations. Under the conditions of the study, there was no evidence of embryotoxicity or teratogenicity. The NOAEC for developmental toxicity was 1200 ppm, the highest dose tested.

Hydrocarbons, C10-C12, isoalkanes, <2% aromatics

In a Segment II teratology study (ExxonMobil Corp., 1978), the test material (Hydrocarbons, C10-C12, isoalkanes, <2% aromatics) was administered to pregnant female rats by inhalation exposure to vapor concentrations of 300 or 900 ppm, 6 hours/day during gestation days 6 to 15 to assess developmental toxicity. Included in this study was a negative control (chamber exposed) group and a positive control group that was treated via gastric intubation on gestational days 6-15 with 400mg/Kg/day of acetylsalicylic acid.  All surviving females were sacrificed on Day 21 of testation and fetuses examined for external, soft tissue and skeletal malformations.  Pregnancy rate, mortality, body weight gain and gross postmortem observations were unaffected by treatment. Treatment at either dose level had no effect on reproductive endpoints, fetal size, sex distribution, ossification variation, or fetal examination endpoints. Thus, there was no evidence of maternal or fetal toxicity at either exposure level of the test material tested.  Based on these results, both the maternal and developmental NOAELs were greater than or equal to 900 ppm (>= 5220 mg/m3).

Additionally, in order to comply with standard information requirements for Annex X substances, Guideline OECD 414 (Prenatal Developmental Toxicity Study) tests in rats and rabbits are proposed for structural analogues, Hydrocarbons, C7-C9, isoalkanes (EC# 921-728-3) and Isohexadecane (2,2,4,4,6,8,8-heptamethylnonane (EC# 224-506-8)). The testing proposals have been presented in the lead registrant dossiers for these substances already submitted to ECHA. This read across is based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in Section 13.2 of the dossier. The endpoint will be updated subsequent to ECHA's approval of the testing proposals and availability of data upon completion of the studies.

Justification for classification or non-classification

Based on available read across data from structural analogues, Hydrocarbon, C4, 1,3-butadiene-free, polymd,, triisobutylylene fraction, hydrogenated does not warrant classification as a reproductive or developmental toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). However, an OECD 422 test will be conducted on a structural analogue Hydrocarbons, C13-C16, isoalkanes, <2% aromatics (EC# 946-885-5) and the endpoint will be updated upon completion of the study. Additionally, further tests with structural analogues (OECD 443 and OECD 414 (rodent and 2nd species)) are proposed and will be conducted subsequent to ECHA's approval of the same. This endpoint will be updated upon completion of the above studies subject to ECHA's approval.

Additional information