Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
1 000 mg/kg bw/day
Additional information

Reproduction Toxicity:

A Reproduction / Developmental Toxicity Screening Test was conducted under GLP according to OECD Guideline 421 to evaluate

toxicity to reproduction and development (BASF, 1995). Thereby, ten male and ten female Wistar rats per dose received 1,6-hexanediol at doses of 100, 400 and 1000 mg/kg/d by gavage. The application period was about four 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. It was found, that the food consumption of F0 males at the 1000 mg/kg bw/day dose level was statistically

significantly reduced during study weeks 0 - 1 and 3 – 4 resulting in a statistically significantly reduced mean body weights at the end of the study. The body weight gains of the high dose F0 males were also statistically significantly lower compared to the control F0

males between test weeks 2 - 3 and over the total study period. However, no substance-related effects on organ weights and no

gross- and histopathological findings were observed in F0 males and females. As there are neither corresponding effects to organ weights nor any effects on histopathology in this study, the observed effect is not considered to be advese. No signs for general toxicity were present in males and in females at 1000, 400 and 100 mg/kg bw/day. In addition, no signs for impairment of reproductive function

and no signs of developmental toxicity in the offspring were apparent. Therefore, the NOAEL for parental and F0 toxicity was found

to be 1000 mg/kg bw/day for females and for males; the NOAEL for reproductive function and for developmental toxicity was 1000

mg/kg/ bw/day.

Short description of key information:
According to the results of an OCD 421 reproductive toxicity screening study 1,6-hexanediol is not reprotoxic. There was no effect at the limit dose of 1000 mg/kg bw/day.
- NOAEL = 1000 mg/kg bw (male; OECD 421)
- NOAEL = 1000 mg/kg bw (female; OECD 421)

Effects on developmental toxicity

Description of key information
NOAEL (maternal and developmental) = 1000 mg/kg/g (OECD414, BASF SE, 2014)
Effect on developmental toxicity: via oral route
Dose descriptor:
1 000 mg/kg bw/day
Additional information

Developmental Toxicity:

The potential of the test sbstance 1 ,6 -hexanediol to induce developmental toxicity was assessed in an OECD414 guideline study (BASF SE, 2014). In this prenatal developmental toxicity study the test compound 1,6-Hexanediol was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) to evaluate its potential maternal and prenatal developmental toxicity.

Analyses confirmed the correctness of the prepared concentrations and the stability of the test substance in the vehicle. Generally, clinical observations revealed no toxicologically relevant findings in the animals receiving 100, 400 or 1000 mg/kg bw/d 1,6-Hexanediol and in the controls. No differences of toxicological relevance between the control and the treated groups (100, 400 or 1000 mg/kg bw/d) were determined for any reproductive parameters, such as conception rate, mean number of corpora lutea, mean number of implantations, as well as pre- and postimplantation loss. Similarly, no influence of the test compound on fetal weight and sex distribution of the fetuses was noted at any dose.

Overall, there was no evidence for any toxicologically relevant adverse effect of the test item on fetal morphology at any dose.

Justification for classification or non-classification

Due to the results of two guideline studies with the test substance 1,6-hexanediol, no classification for reproductive/developmental toxicity is necessary according to Directive EC67/548/EEC (DSD) and EC1272/2008 (CLP), respectively.