Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: See below, a 5-day RF study was started but had to be finished prematurely because of rapid and severe skin reactions.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
The 28-day test was cancelled because of rapid and severe skin reactions during the 5-day dose range-finding test. See below.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Based on:
test mat.
Basis for effect level:
other: The 28-day test was cancelled because of rapid and severe skin reactions during the dose range-finding test. The dose not causing dermal reactions would be < 1/10 of the NOAEL found in the 28-day oral study (NOAEL oral = 50 mg/kg bw).
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Based on the acute dermal toxicity study (LD50 > 2000 mg/kg bw), a 5 -day dermal range-finding study was carried out with 1000 and 300 mg/kg bw/day. This resulted in severe skin damage with local or generalised erythema, necrosis and scab formation. Renewed range finding with 100 and 30 mg/kg bw/day gave identical results, viz. 30 mg/kg bw induced severe local effects already visible on days 3, 4 and 5.

Applicant's summary and conclusion

Conclusions:
The 28-day test was cancelled because of rapid and severe skin reactions during the dose range-finding test. The dose not causing dermal reactions would be < 30 mg/kg bw and was assumed to be < 1/10 of the NOAEL found in the 28-day oral study (NOAEL oral = 50 mg/kg bw); hence a dermal study was deemed not to provide useful information with regard to systemic toxicity.