Chlorphenesin

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

NOAEL reproductive toxicity Chlorphenesin = 100 mg/ kg bw/day base on WoE approach.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

100 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

Studies conducted according to internationally accepted testing guidelines.

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

The assessment for toxicity to reproduction of Chlorphenesin is based on weight of evidence approach using the data obtained by 28 days repeated oral toxicity study performed in 1990 and by prenatal developmental toxicity study in 1994.

- In 28 days repeated oral toxicity study Chlorphenesin was administered orally to rats at dosage levels of 1000, 100 and 10 mg/kg bw/day. No effect on reproductive organs was recorded .

- In prenatal developmental toxicity study Chlorphenesin was tested to evaluate the effect of on pregnancy and in utero development of the rat. Doses of 0 (Control), 10, 50 and 100 mg/kg were administered to groups of twenty-five females, by oral gavage once per day, from Days 6 to 15 post coitum inclusive. The number of non pregnant rats and as well as the ratio No. of implantation/ No. of corpora lutea of the control group were comparable to values found for the treated groups.

As conclusion NOEL reproductive toxicity of Chlorphenesin= 100 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

NOEL developmental toxicity Chlorphenesin = 100 mg/ kg bw/day

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

100 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on developmental toxicity: via dermal route

Quality of whole database:

Study conducted according to internationally accepted testing guidelines.

Additional information

In vivo test regarding developmental toxicity of Chlorphenesin was performed in 1994, before the implementation of the Regulation (EC n.1223/2009). Chlorphenesin was tested to evaluate the effect of on pregnancy and in utero development of the rat. Doses of 0 (Control), 10, 50 and 100 mg/kg were administered to groups of twenty-five females, by oral gavage once per day, from Days 6 to 15 post coitum inclusive. For all dosage there is no evidence of maternal toxicity and no adverse effects on embryofoetal survival, growth and development in utero were recorded. The NOEL for Chlorphenesin in developing foetus was considered 100 mg/kg bw/day.

Justification for classification or non-classification

Chlorphenesin is not classified for reproductive toxicity according to the CLP Regulation (EC.n.1272/2008). For justification see the results of available studies.