Registration Dossier
Registration Dossier
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EC number: 222-048-3 | CAS number: 3327-22-8
Endpoint summary
Administrative data
Description of key information
The key oral study, conducted in a manner similar to (the now deleted) OECD 401 involved gavage administration of one of five doses of a 60% solution of CHPTAC to male and female rats. An LD50 value of 3.2 ml/kg bw was reported (equivalent to 3688 mg/kg bw, or 2213 mg/kg bw for pure CHPTAC).
The key dermal study, conducted according to OECD 402, involved 24-h occluded contact with the test material (65% aqeous CHPTAC). An LD50 value in rats in excess of 2348 mg/kg bw was derived for the test material, that has been said to equate to 1526 mg/kg bw for 100% CHPTAC.
No suitable data are available for the inhalation route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 213 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 526 mg/kg bw
Additional information
ORAL
The key oral study was chosen from 4 studies of reliability 2 (reliable with restrictions) as the most recent of those for which sufficient data were available for review during entry to IUCLID5. Findings from the remaining three studies supported those of the key study. Where adequate data were available the LD50 values for pure CHPTAC were in every case greater than 2000 mg/kg bw/day. For a further two studies (reliability 4) an LD50 of >2000 mg/kg bw/day was also given, apparently in relation to an aqueous solution of CHPTAC, giving a conversion to an LD50 lower than 2000 mg/kg bw/day for the pure substance. However, sufficient details were not available during entry to IUCLID5 for this to be reliably ascertained.
The study selected by FIN to provide the LD50 used in risk characterization (Kynoch et al., 1982/Dynamit Nobel, 1982) was not available during entry to IUCLID5. The LD50 value identified in this study is very similar to that of the key study.
DERMAL
The key dermal study was chosen from two very similar studies in the rat. The findings of the supporting study confirm those of the key study
Justification for classification or non-classification
The available data do not support classification via the oral route (Regulation (EC) No 1272/2008; Directive 67/548/EEC).
The studies identified do not indicate classification via the dermal route for the test material (Regulation (EC) No. 1272/2008; Directive 67/548/EEC). However, conversion to account for the concentration of CHPTAC in the test material means that the tested dose of pure CHPTAC was slightly lower than the upper value (2000 mg/kg bw) above which classification would not be required.
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