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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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.