Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted method; old study with limited documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Remarks:
Study conducted 1974; limited documentation
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Flectol H; no further data on purity

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
4, 24, 48, 72 and 168 hours after treatment
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 168 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24, 48, 72, 168 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
No effects mentioned in report

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test compound was not irritating to the skin in an study equivalent to OECD TG 404 with 6 rabbits dosed with 500 mg TMQ.