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Description of key information

28-day Repeated dose toxicity

oral:NOAEL is 15 mg/kg bw/day (EU method B.7)

Key value for chemical safety assessment

Toxic effect type:

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
15 mg/kg bw/day
Study duration:

Additional information

Repeated dose oral toxicity

The repeated dose toxicity was evaluated in a well conducted GLP and EU method B.7 study with Sprague-Dawley rats. 10 rats per group (5 per sex) were gavaged with Chiguard 380/Chiguard 380W at dose of 0 mg/kg bw/day, 15 mg/kg bw/day, 150 mg/kg bw/day and 1000 mg/kg bw/day for 7 days per weeks. The exposure duration is 28 days.

There were no clinical signs or mortalities, nor any adverse treatment-related changes in body weight (gain), food and water consumptions. No adverse treatment-related changes in haematology or biochemistry. Liver weight (adjusted for body weight) was statistically significantly increased (dose-dependently) in male rats given 150 and 1000 mg/kg bw/day. In the 1000 mg/kg group the increased liver weight was accompanied by an increased incidence of congestion (incidences were 1/5 and 4/5 in males of the control group and the 1000 mg/kg group, respectively.)

Microscopic examination of the testes reveled vacuolation of the Sertoli cells of some tubules in 0/5, 1/5, 2/5 and 3/ 5 males of the groups given 0, 15, 150 and 1000 mg/kg bw, resp.

NOAEL of 15mg/kg bw/day was established in the study.

Repeated dose dermal toxicity

No relevant information is available.

Repeated dose inhalation toxicity

No relevant information is available.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 380/Chiguard 380W (CAS# 18600-59-4) needs no classification for specific target organ toxicity after repeated exposure when considering the criteria outlined in Annex I of 1272/2008/EC.