Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2007
Bibliographic source:
IUCLID4 data set, 2007

Materials and methods

Test guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
male/female (each 3)

Test system

Type of coverage:
occlusive
Vehicle:
other: paraffin oil
Controls:
other: animals were their own control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h exposure
Observation period:
10 days
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.6 - 5.0 kg
- Number of animals: 3 males, 3 females
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 0.5 g wetted with paraffin oil
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 10 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and
Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 7, and 10 days after patch
removal; evaluation based on readings 1-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4h
Score:
1.28
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4h
Score:
0.17
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4h
Score:
1.25
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.17
- irritation index: 1.25/8
REVERSIBILITY: complete within 10 days
OTHER EFFECTS: eschar formation in the males (day 7)

Any other information on results incl. tables

See also attached IUCLID4 dossier.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification : not irritating