Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Initial age: approx. 4.5 months
- Weight at study initiation: 2.1 - 2.3 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
other: the surrounding untreated skin served as control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: no residual test item had to be removed
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 9 - 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1 - 2
Max. score:
4
Reversibility:
fully reversible within: 8 - 10 days
Irritation parameter:
other: induration, laceration and peeling of skin
Basis:
other: all 3 animals
Time point:
other: 72 h up to day 11
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: 72 hours after treatment induration of the skin became obvious which lasted up to and including day 7; laceration of the skin appeared on day 5 followed by peeling on days 8 to10 which lasted up to and including day 11.
Other effects:
No systemic intolerance reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

In a dermal irritation study according to OECD TG 404 the test material was applied under semiocclusive conditions for 4 hours to the shaved skin of 3 rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. Erythema (grade 1) and oedema (grade 1 - 2) was observed in all animals 24 hours to days 7 - 10 after treatment. In addition, induration of the skin, laceration and peeling of the skin was noted in all animals. The effects partly lasted up to day 11 after patch removal. The test material should therefore be regarded as irritating to the skin of rabbits. No systemic intolerance reactions were observed.

According to classification criteria Butanoylanilin is an irritant to the skin.