Registration Dossier
Registration Dossier
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EC number: 204-817-5 | CAS number: 126-98-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 7 mg/kg bw/day
Additional information
Reduced sperm count is noted in one study (Wolfe et al, 1997). However, the effect fell within historical values and took place in a dose range where other systemic effects occur. Given the absence of effects on reproductive performance, and bearing in mind the nature of the primary toxic principle, this is considered to be a sign of general toxicity rather than a specific effect on reproduction.
Short description of key information:
NOAEL for reproductive toxicity 7 mg/kg/day in male rats and 20 mg/kg/day in females (NTP continuous breeding protocol)
Effects on developmental toxicity
Description of key information
NOAEL for maternal toxicity in the rat ≥ 50 mg/kg/day in the rat (NTP Protocol)
NOAEL for development toxicity ≥ 50 mg/kg/day in the rat (NTP Protocol)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
Additional information
A decrease in sex ratio presented as smaller numbers of male offspring per maternal rabbit after oral adminstration (George et al, 1996) and foetal bodyweights were reduced following exposure via the inhalation route (Saillenfait et al, 1993). However, reproductive performance was unaffected and the foetal body weight changes mirror transient body weight effects in young adult rats observed at the beginning of a 91 day study in the same dose range (Pozanni, 1968). The effects lack specificity, occur in correlation with parental toxicity, and fail to demonstrate teratogenicity.
Justification for classification or non-classification
The substance does not meet the criteria for classification under the terms of Directive 67/548/EEC or GHS as implemented by Regulation (EC) 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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