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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, guideline-conform study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: WF 4746

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Acclimatization period: at least 8 days before study start
Mean body weight: male 3.18 kg, females 2.92 kg
Singly housing in stainless steel wire mesh cages (floor area 40 x 51 cm).
The animals were identified via ear tattoo.
They were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
The animals were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the animals
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 min after removal of the test patches and 24 h, 48 h, 72 h after the beginning of the application
Number of animals:
3
Details on study design:
Clipping of the fur at least 15 hours before study start.
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Removal of the test substance at the end of the application period with Lutrol and Lutrol/water (1:1).
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after beginning of application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met