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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
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: compact

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever Kaninchenfarm, D-2740 Bremervörde
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single caging in battery of cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +- 2°C
- Humidity (%): 50 - 85 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): neat

Duration of treatment / exposure:
24 h
Observation period:
24 h, 48 h, 72 h
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: rubber sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
24 h, 48h, 72 h

On each rabbit two areas of the back were designated for the position of the patches. One of the areas was scarified by making epidermal incisions.
For evaluation the cumulative scores were averaged for both scarified and intact skin and were added together to calculate the primary irritation index.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Rewopal V 2762 is not irritant to skin of rabbits.