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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:
22 - 29 August 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:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1984
GLP compliance:
yes

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: Ranch Rabbits, Crawley Down, Sussex
- Sex: female
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2 kg
- Housing: individually in grid bottomed metal cages
- Diet: antibiotic free rabbit diet (SQC standard rabbit pellets produces by Special Diets Services, Witham, Essex) ad libitum
- Water: drinking water via automatic nozzels ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 51 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g powder with 0.5 mL destilled water. 0.5 g of the test material was placed evenly over a 2.5 cm square of surgical lint.
Duration of treatment / exposure:
4 hours
Observation period:
7 days after removal of the patches
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: left flank, immediately caudal to the last rib
- % coverage: not specified
- Type of wrap if used: Elastoplast, elastic adhesive bandage 10 cm wide

REMOVAL OF TEST SUBSTANCE
- Washing: yes, gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours and 7 days after removal of the patches

SCORING SYSTEM:
- Method of calculation: Irritation was assessed and allocated a numerical value based on erythema and eschar formation or oedema formation (Draize scoring system).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2 &4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.166
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Irritation of the skin (erythema score 0.5 of 4) was only apparent in animal 3 after 1 and 24 h, after 48 h no effect was recorded.
Other effects:
- Other adverse local effects: not specified
- Other adverse systemic effects: not specified

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
No skin irritating effects of the test item were recorded after 48h.
Executive summary:

The test was based on the descriptions for skin irritation, EEC Commission Directive of 25 April 1984 (84/449/EEC), page 106 to 108 of document L251. 0.5 mL aliquots were applied over an areea of 6 cm² on the dorsal skin, clipped free of fur, of four albino rabbits. The material was held in contact with the skin under a semi-occlusice dressing for a four hour period after which the patches were removed. Skin reaction to the materials was assessed after 1, 24, 48 and 72 h and 7 days. Irritation of the skin was only apparent after 1 and 24 h, after 48 h no effect was recorded.