Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino rabbits, strain HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours, 7 and 14 days after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: Fixomull - stretch Klebeflies, semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water without altering the existing response of the integrity of the epidermis
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean of 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean of 24, 48, 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: slight oedema (mean score: 0.3)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean of 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: slight oedema (mean score: 0.3)
Irritant / corrosive response data:
erythematous and exsudative reactions; in 2 animals not proved to be fully reversible within 14 days
mean irritation index calculated by averaging the total scores of all 6 rabbits: erythema and eschar formation (2.02), oedema formation (0.1)
Other effects:
There were no systemic intolerance reactions recorded.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information
Conclusions:
moderately irrtating to skin



Classification: not irritating
Executive summary:

In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be an irritant to the rabbits skin. No relevant systemic intolerance reactions were observed.