Registration Dossier

Administrative data

Endpoint:
chronic 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: Summary study report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
I U C L I D D a t a s e t Substance ID: 68334-30-5
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
Bibliographic source:
I U C L I D D a t a s e t Substance ID: 68334305 pag 658-659

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
API procedure
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
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:
28 days
Frequency of treatment:
3 times per week, total of 12 applications
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
200 mg/kg
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:

Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
2000 mg/kg
Basis:
nominal per unit body weight
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 2 000 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

NO SYSTEMIC EFFECTS were found.

SKIN IRRITATION at the treatment site was found in ALL GROUPS. It was described as severe for high dose animals, moderate for middle dose animals, and slight for low dose animals. Two high dose animals died and two were sacrificed.

No treatment related effects were evident from the haematology, clinical chemistry and organ weight data

Applicant's summary and conclusion