Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: RELIABLE SUMMARY REPORT
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
IUCLID DATASET SUBSTANCE ID:68512-62-9
Author:
EUROPEAN CHEMICAL BUREAU
Year:
2000
Bibliographic source:
IUCLID DATASET SUBSTANCE ID:68512-62-9 PG 56

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
API method described in the study conducted by Elars Bioresearch Laboratories. Report No. 27–32813, API,
Washington DC, 1980.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 consecutive days, tw o–day rest period, then 5 additional consecutive days
Frequency of treatment:
daily, covered for 24 hours
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
1 ml/kg/day
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
2 ml/kg/day
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
2.5 ml/kg/day
Basis:
nominal per unit body weight
No. of animals per sex per dose:
4

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
ca. 1 070 mg/kg bw/day
Based on:
not specified
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The major systemic effect was MULTIFOCAL NECROSIS of the LIVER at ALL DOSE LEVELS. CENTRILOBULAR VACUOLAR DEGENERATION was also found. SIGNIFICANT SKIN IRRITATION was found at the TREATMENT SITES. Effects ranged from slight to severe and included acanthosis, acute inflammation, chronic inflammation, crusting, deep pyoderma, dermal congestion, dermal oedema, hyperkeratosis and epidermal necrolysis.

Applicant's summary and conclusion