Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Additional information

Key study: The similarity observed between data from the first and third generation failed did not prove any evidence of a cumulative effect due to long-term ingestion of PGPR over three successive generations. No effects on animal growth or food intake were observed. There were no effects of PGPR on the sucking pups receiving this substance from mother's milk. The ingestion of 1.5% PGPR in diet (equivalent to 2g/kg b.w.) did not produce any adverse effects on reproductive capacity or development of the offspring during three generations of continuous exposure.

Supporting study (text copied from OECD SIDS dossier of glycerol, page 20):

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 (Wegener 1953).

Additional information on the effects of glycerol on fertility can be found in the OECD SIDS dossier. Please find hereafter the conclusion copied from the OECD SIDS dossier (page 21): Based on the available data, it can be concluded that glycerol does not have any adverse effects on reproductive parameters. The evidence of effects on spermatogenesis following intratesticular administration are not considered relevant as an exposure route. These data do not cause concern in relation to reproductive effects from anticipated routes of exposure.


Short description of key information:
Toxicity to reproduction data are based on the read across substances glycerol and Polyglycerol esters (PGPR). See "Read across report" attached to the dossier.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 310 mg/kg bw/day
Additional information

Please find hereafter the information on the developmental toxicity of glycerol (text copied from OECD SIDS dossier of glycerol, page 20-21):

Rats, mice and rabbits were treated daily with glycerol at dose levels up to 1310, 1280 and 1180 mg/kg bw (oralgavage), 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 (NTIS 1974). From these studies a NOAEL of 1180 mg/kg bw can be derived. The results from a Frog Embryo Teratogenesis Assay-Xenopus (FETAX, see also 4.1.4) were ambiguous. Since there is no other evidence of developmental effects especially on mammals, the results of this screening assay for developmental toxicity are not considered to be relevant to mammals. The authors considered the response to be a false positive (Bantle 1999).

Please find hereafter the conclusion copied from the OECD SIDS dossier of glycerol (page 21):There was no evidence of teratogenicity. The NOAEL for developmental toxicity is 1180 mg/kg bw.

Justification for classification or non-classification

The test substance does not have to be classified for toxicity to reproduction since no adverse effects on reproduction were observed in available studies.