Pentane-1,2-diol

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

There are no studies concerning toxicity on reproduction available for 1,2 pentanediol. However, oral studies are available for a structural closely related substances such as 1,2 butanediol (OECD 422) and 1,2 hexanediol (OECD 414). Available data is sufficient for a risk and hazard assessment concerning toxicity on reproduction.

A Reproduction / Developmental Toxicity Screening Test was conducted according to OECD Guideline 422 and GLP to evaluate toxicity to reproduction and development is available for 1,2 butanediol (JETOC, 1995). Ten male and ten female Wistar rats per dose received 1,2 butanediol at doses of 40, 200 and 1000 mg/kg/d by gavage. The application period was about seven weeks for males and about six weeks for the females starting at least 14 day before mating. After the mating period, the male animals were sacrificed while the females were allowed to litter and rear their pups until day 4 post partum. Thereafter, the pups (F1-generation) and the F0-females were sacrificed.

Not any reproductive toxicity was observed in parental animals and offspring in doses up to 1000 mg/kg bw. Parameters of copulation, implantation, pregnancy, parturation and lactation did not differ from the control. No abnormal pubs were observed and no loss of offspring occurred. Therefore, the NOAEL for reproductive function and for developmental toxicity was 1000 mg/kg/ bw/day for 1,2 butanediol.  Due to the structural similarities, the same result could also be expected for pentane-1,2-diol.

Short description of key information:
Fertility:
- NOAELparent. = 1000 mg/kg bw (OECD 422; Analogy CAS 584-03-2)
-NOAEL F1 = 1000 mg/kg bw (OECD 422; Analogy CAS 584-03-2)

Effects on developmental toxicity

Description of key information

Developmental toxicity:
- NOAELmat. = 300 mg/kg bw ( OECD 414; Analogy CAS 6920-22-5)
- NOAELdevelop/tera = 300 mg/kg bw (OECD 414; Analogy CAS 6920-22-5)

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

300 mg/kg bw/day

Additional information

There are no studies concerning toxicity on reproduction available for 1,2 pentanediol. However, oral studies are available for a structural closely related substances such as 1,2 butanediol (OECD 422) and 1,2 hexanediol (OECD 414). Available data is sufficient for a risk and hazard assessment concerning toxicity on reproduction.

1,2 hexandiol was tested for developmental toxicity in an oral gavage study in rats according to OECD 414 and GLP. 24 pregnant Crl:CD rats received 300, 100 and 30 mg 1,2 hexanediol/kg bw/day daily form day 5 to 19 of gestation. Dose levels were selected for use in this study based on results of a range finding study. In this preliminary study, a dose level of 500 mg/kg bw /day was associated with clear adverse clinical signs (noisy respiration, including decreased laboured respiration and gasping in one case), that excluded this dosage level from use in this main investigation. At 1000 mg/kg respiratory distress and mortality in two cases occurred. A high dosage of 300 mg/kg bw /day was therefore chosen in anticipation of a degree of toxicity that would not impair the assessment of embryofoetal development.

The daily administration of the test item during the period of organogenesis, at dose levels up to 300 mg/kg, was not associated with any adverse effect on the pregnant rat or on the developing conceptus. The "No Observed Effect Level" (NOEL) for the pregnant female and for embryofoetal survival, growth and development was therefore considered to be 300 mg/kg/day.

Justification for classification or non-classification

Due to the results obtained in a developmental toxicity screening study performed according to OECD guideline 422 with the structural analogue 1,2 butanediol and in a dermal OECD 414 with the structural analogue 1,2 hexanediol no classification is necessary.

The classification criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 were not met.