Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (Draize test) with acceptable restrictions (occlusive dressing, intact and abraded skin test sites, TS substance preparation: 50%, 24 hours exposure duration, only 7-day observation period; TS purity not specified; non GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
Principles of method if other than guideline:
Draize test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: red powder
- Lot/batch No.: EN 97
No additional details provided

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgaeu, Germany and MADOERIN AG, 4414 Fuellinsdorf, Switzerland
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): standard rabbit food - NAFAG, No. 814, Gossau SG; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or abraded (only data from the shaved skin sites are presented here, since they are suitable for assessment)
Vehicle:
other: The test material was prepared for application in polyethylene glycol + saline (70 : 30 parts).
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): as 50% in polyethylene glycol
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of the right flank (the whole back and flanks was shaved with an electric clipper). The shaven skin on the left side was slightly scarified immediately before treatment.
- % coverage: the patch the patches were covered with an impermeable material
- Type of wrap if used: the covered patches were fastened to the body of the rabbit with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: the patches were removed 24 hours after the application

SCORING SYSTEM: comparable to the OECD scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Mean of all tested animals
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
Mean of all tested animals
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritation was observed on intact skin sites. It could therefore be assumed that the test substance is not irritating according to EU-CLP.
Other effects:
A slight irritation (edema score 1 and erythema score 1 in one female animal) was observed on abraded skin sites 24 hours after treatment, but was completely reversible within 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information