Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 July to 6 July 2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EC Directive 92/69/EEC, B.4 Acute Toxicity – Skin Irritation
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
clear colorless liquid,
density 1.60,
pH not provided

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Sex: Male

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
0.5 ml applied to 150 cm2 skin - Applied undiluted
Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions were assessed at 1, 24, 48 and 72 hours after removal of dressings and test substance.
Number of animals:
3 males
Details on study design:
TEST SITE
150 cm2 skin
Applied undiluted
SCORING SYSTEM:
Grading scale: 0-4 for erythema and eschar formation; 0-4 for oedema

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
ca. 0
Irritant / corrosive response data:
No skin irritation was noted at any time point. Scores of 0 for erythema and oedema were observed at all time points.
Primary Irritation Score = 0
Other effects:
No symptoms of systemic toxicity were observed during the study and no mortality occurred.

Any other information on results incl. tables

No skin irritation was noted at any time point. Scores of 0 for erythema and oedema were observed at all time points.

Primary Irritation Score = 0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
The test substance was found to be non-irritating according to OECD 404 and EC Commission Directive 92/69/EEC B.4