Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

OECD 421 ongoing following ECHA decision but not yet completed (see endpoint record). Read-across to Cyclamen aldehyde maintained for assignement of NOAEL and Hazard labelling until definitive study is available.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
OECD 421 Ongoing. Read across to Cyclamen aldehyde to determine NOAEL and C&L whilst waiting for OECD 421.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Based on the results of the 5 day oral study it was concluded that treatment of sexually mature male CD rats with Bourgeonal was associated with marked systemic toxicity at 250 and 100 mg/kg/day. Treatment at 100 mg/kg/day was also associated with testicular and epididymal toxicity and the urine contained TBBA.

Reading across to Cyclamen Aldehyde, a 90 day study shows an NOAEL of 25mg/Kg bw/d


Short description of key information:
5 day oral study - marked systemic toxicity at 250 and 100 mg/kg/day. urine contained TBBA.
Reading across to Cyclamen Aldehyde, a 90 day study shows an NOAEL of 25mg/Kg bw/d

Justification for selection of Effect on fertility via oral route:
Based on the results of the 5 day oral study it was concluded that treatment of sexually mature male CD rats with Bourgeonal was associated with marked systemic toxicity at 250 and 100 mg/kg/day. Treatment at 100 mg/kg/day was also associated with testicular and epididymal toxicity and the urine contained TBBA.
Reading across to Cyclamen Aldehyde, a 90 day study shows an NOAEL of 25mg/Kg bw/d

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the effects observed on fertility, the material has been classified Reproduction toxicity Category 2 - H361f: Suspected of damaging fertility in accordance with 1272/2008/EC (CLP).