Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
8 - 11 Dec 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The non-GLP study was performed equivalent to an appropriate OECD guideline. Only 10% active ingredient (a.i.) tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Journal Officiel de la Republique Francaise (1982)
Deviations:
yes
Remarks:
10% a.i. tested, reading time points 24 and 72 h only, limited study design information
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: fluid gel, not further specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: distilled water
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 55% a.i. product diluted to 18.2%, (i.e. 10% a.i.)
Duration of treatment / exposure:
no data
Observation period:
Reading time points: 24 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 0.5 mL of the solution was laid down on a square gauze which was immediately applied on the skin of each rabbit.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed
Irritant / corrosive response data:
Slight erythema formation (grade 1) was recorded in all animals 24 h after start of exposure. These effects were fully reversible in all animals within 72 hours. No edema formation was detected in any animal.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be not irritating to skin when applied as 18.2% (10% a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Not irritating ≤10% (a.i.)
Skin Irrit. Cat. 2 >10% (a.i.)