Oxybispropanediol

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

2 000 mg/kg bw/day

Species:

rat

Additional information

No studies with diglycerol itself are available. See read across substances in section 12 in IUCLID for read across report.

Key study: An oral three generation reproduction study was performed with rats given 1.5% of PGPR by feed. No effects on animal growth was observed during the first 4 months of each generation. The weights of the females were recorded at weaning and mating while the weight of the males was recorded at weaning and at day 65. There were no significant differences between weights in treated or control rats. Food intake: was not recorded in this study, but a previous study indicates that levels of 5% PGPR in the diet had no effects on food intake. The rats were observed daily. There were no deaths and no evidence of abnormal behaviour or functional disorders in all 3 generations. In general for both groups the breeding performance was better in the 1st and 3rd generation. In the 2nd generation the breeding was poor in the control and PGPR group. The only significant difference was a greater percentage in the controls of litters weaned entirely which was reversed in favour of the PGPR rats in the third generation. There were no effects of PGPR on the sucking pups receiving the substance from mother's milk. Histopathology did not show any lesions. The ingestion of 1.5% PGPR in diet (equivalent to 2 g/kg bw) did not produce any adverse effects on reproductive capacity or development

of the offspring during three generations of continuous exposure. Supporting study:

In a two generation study not fully matching current OECD Guidelines, male and female rats (10/treatment) were dosed daily with glycerol (20% solution in water) during 8 weeks before mating. Females received glycerol throughout pregnancy or until weaning of the F1 generation (5 each). When the F1 generation was ~100 days of age, pups were killed except for 10/sex. These animals were used to produce the F2-generation. No effects were found on the reproductive efficiency of the parents, nor on the growth, fertility, reproductive performance of the untreated F1 generation, and no histological changes occurred in the tissues of both the F1 and F2 generation. Although the data are limited, a NOAEL of >=2000 mg/kg bw was identified from this study.

Short description of key information:

Oral reproduction studies with PGPR and glycerol are available, a 3- and 2-generation reproduction study, respectively, with rats.

Effects on developmental toxicity

Description of key information

An oral developmental toxicity study with glycerol is available. The study is performed with rats, rabbits and mice.

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

1 310 mg/kg bw/day

Effect on developmental toxicity: via inhalation route

Species:

other: rats, mice and rabbits

Additional information

No study with diglycerol itself is available. Rats, mice and rabbits were treated daily with glycerol (read across substance, see section 13 of IUCLID for read across report) at dose levels up to 1310, 1280 and 1180 mg/kg bw (oral gavage), respectively, during part of the gestation period. The study protocol was in reasonable agreement with the requirements of the OECD 414 (1981). No maternal toxicity or teratogenic effects were seen at the highest dose levels tested . From this study a NOAEL for rats of >=1310 mg/kg bw can be derived. Based on the available data, there was no evidence of teratogenicity..

Justification for classification or non-classification

Based on the available data for reproduction and developmental toxicity, diglycerol does not have to classified for reproduction and developmental toxicity according to CLP Regulation (EC) No. 1272/2008.