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Effects on fertility

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

Three studies were available, one for reprotoxicity and two for teratogenicity. Only one study was considered as validity 2, it is a combined repeated dose toxicity study with the Reproduction/Developmental Toxicity Screening Test (OECD 422).

In this study of R. Ceccatelli (2009), catechol was administered by gavage at doses of 0, 30, 80, 160 mg/kg body weight/day to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. For general toxicity the main effect reported was at 80 and 160 mg/kg/day, incidence and severity of squamous hyperplasia in the stomach for both sexes. This lesion represents a localized stomach reaction to a repeatedly gavages irritant test material.

Reproduction and Breeding regarding mean precoital time, conception rate, fertility and gestation indexes were not affected by the treatment with the test item. Same conclusion for implantation rate and post-implantation loss. The treatment with the test item did not reveal any effects on the completeness of stages or cell populations of the testes.

The mean number of pups at first litter check and on day 4 post partum was not affected by the treatment with the test item. The sex ratio was also not affected.

Pup weight development was not affected by the treatment with the test item. At necropsy of pups, no test item-related findings were noted.

The general NOEL (No Observed Effect Level) was considered to be 30 mg/kg/day, due to the squamous hyperplasia in the stomach. This lesion represents a localized stomach reaction to a repeatedly gavage irritant test material.

The NOEL for reproduction/developmental toxicity was considered to be 160 mg/kg/day, the highest dose tested without observed effect.

In the carcinogenicity studies, the reproductive organs were observed and no effects were reported indicating that catechol did not affect the reproductive organs.


Short description of key information:
Three studies were available, one for reprotoxicity and two for teratogenicity. Only one study was considered as validity 2, it is a combined repeated dose toxicity study with the Reproduction/Developmental Toxicity Screening Test (OECD 422).

Effects on developmental toxicity

Description of key information
no valid data are available
Additional information

The two available teratogenicity studies were considered of low validity (Klimisch 3) so possible teratogenic effect of Catechol could not be evaluated.

Justification for classification or non-classification

Regarding results available in the OECD study 422 and according to classification criteria of EC regulation 1272/2008 the catechol should not be classified for reproductive toxicity.

Additional information

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