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Key value for chemical safety assessment

Effects on fertility

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

A multi-generation reproduction study evaluating 2-phenoxyethanol according to the Reproductive Assessment by Continuous Breeding Protocol (NTP, 1984) was conducted by the National Toxicology Program and reported in a peer-reviewed journal (Heindel et al, 1990). In this study, male and female mice were given 2-phenoxyethanol in feed at dose levels of approximately 0, 375, 1875 or 3,700 mg/kg bw/day.

The oral feeding with 2-phenoxyethanol resulted in loss of body weights (-2%) of high-dose males compared to controls, while female body weights were unaffected. There were also no significant differences in feed consumption. Liver weights were increased at the highest-dose level. 2-Phenoxyethanol had no effect on fertility. However, the number of litters/pair, the litter size, proportion of pups born alive and pup body weights were decreased at the highest dose. The only effect observed at the mid-dose level consisted of an equivocal lower pup body weight. There were no effects on any of these parameters at the low-dose level. A crossover mating trial demonstrated no effects on mating or fertility, however, pup body weights of females given 3,700 mg/kg bw/day of the test substance were lower than the controls. In summary, fertility was minimally decreased at a dose that caused neonatal toxicity. Reproductive performance in the low- and mid-dose groups was unaffected. The NOAEL for parental and neonatal toxicity was 375 mg 2-phenoxyethanol/kg bw/day.


Short description of key information:
In a multi-generation study, fertility was minimally decreased at a dose that caused neonatal toxicity. The NOAEL for parental and neonatal toxicity was 375 mg 2-phenoxyethanol/kg bw/day.

Effects on developmental toxicity

Description of key information
In a dermal rabbit and oral (gavage) rat teratogenicity study, no effects on the developing foetus were seen.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Effect on developmental toxicity: via dermal route
Dose descriptor:
NOAEL
600 mg/kg bw/day
Additional information

In prenatal developmental toxicity studies, no effects on the developing foetus were seen in rats and rabbits (BASF AG, 2006 and Dow Chemical USA, 1985 and 1987).

In rats, oral administration of 2-phenoxyethanol elicited distinct signs of maternal toxicity at a dose level of 1,000 mg/kg bw/day (BASF AG, 2006). The test compound had no influence on gestational parameters and induced no signs of developmental toxicity up to and including the highest test dose of 1,000 mg/kg bw/day. In particular, there were no indications of teratogenic effects, which were causally related to the test substance. The NOAEL for maternal toxicity is 300 mg/kg bw/day. The NOAEL for prenatal developmental toxicity was 1,000 mg/kg bw/day.

In rabbits, dermal administration of 600 and 1000 mg/kg bw/day resulted in intravascular red blood cell haemolysis and death of some dams (Dow Chemical USA, 1985 and 1987). No treatment-related malformations occurred. Also fetuses from animals treated with 1000 mg/kg bw/day which survived to day 28 did not exhibit external, visceral or skeletal alterations. The NOAEL for teratogenicity and embryotoxicity was >600 mg/kg bw/day and for maternal toxicity was 300 mg/kg bw/day.

Toxicity to reproduction: other studies

Additional information

Not required.

No relevant data available (literature search was performed).

Justification for classification or non-classification

The available data is conclusive but not sufficient for classification.