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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: Test procedures cannot be subsumed under testing guideline, nevertheless are well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
- Age at study initiation: approx. 12 -14 weeks.
- Weight at study initiation: 2220 g - 2770 g.
- Housing: individually.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12/12 hrs dark / hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 12 - 16 square cm
- Type of wrap if used: aluminium foil.

SCORING SYSTEM: OECD Scoring System.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
other: mean 24, 48 and 72 hrs
Score:
< 2.3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
other: mean 24, 48 and 72 hrs
Score:
< 2.3
Reversibility:
fully reversible
Irritant / corrosive response data:
Slighly erythema was robserved in one rabbit. The effect is reverseble within 72 hours.

Any other information on results incl. tables

Animal/sex Reaction 1 hr 24 hrs 48 hrs 72 hrs Mean 24, 48 and 72 hrs
1 Erythema 0 0 0 0 0.00
2 Erythema 2 1 0 0 0.33
3 Erythema 1 0 0 0 0.00
1 Oedema 0 0 0 0 0.00
2 Oedema 0 0 0 0 0.00
3 Oedema 0 0 0 0 0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Non irritating.
Executive summary:

Method

The skin irritation potential was tested in New Zealand White rabbits. The procedure used are similar to those described in the OECD Guidelines 404.

Results

Slight erythema was observed in one rabbit. The effect is reversible within 72 hours.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).

In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1272/2008) Regulation.