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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:
From August 09 to September 06, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 17.07.1992
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
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: Interfauna UK Ltd Wyton, Huntingdon, England
- Age at study initiation: adult
- Weight at study initiation: the animals were weighed immediately before application of the test substance.
- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions.
- Diet: standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning.
- Water: tap water ad libitum.
- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room.
- Health check: approx. 24 hours before the test fur was shaved from the dorso-lateral area of the trunk (6×6 cm) of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healty and intact skin were used.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 1.5 °C
- Humidity: 60-80 %
- Air changes:12-15 times per hour
- Photoperiod: from 6 am to 6 pm, 12 hours artifical illumination.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: test substance was moistened with deionised water and subsequently applied to a hypoallergenic Hansamed patch. A further patch was moistened with water.
- Type of wrap if used: the patches prepared in this way were placed in the opposite dorso-lateral areas of the trunk of each animal and were held in place with semiocclusive dressing for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: after exposure time the dressing was removed and the exposed skin areas were carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 hours.

SCORING SYSTEM
For each animal the Draize scores recorded at 24, 48 and 72 h were added up. The total was divided by 3 to give the irritation index. This index was separately calculated for erythema/eschar formation and for oedema formation.

Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
WelI-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than I millimetre and extending beyond the area of exposure) 4

Interpretation of results - irritation index:
0.0 - 0.99 no irritation
1.0 - 1.99 slight irritation
2.0 - 2.99 moerate irritation
3.0 - 4.0 severe irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritant / corrosive response data:
Evaluation of erythema was not possible in all three animals due to the intense colouration by test substance. Neverthless no other inflammatory signs (oedema or eschar formation) became apparent within the observation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and test substance may therefore be regarded as "not irritating" to the skin.

Any other information on results incl. tables

Individual reactions

Animal Reactions Score at
1 hr 24 hrs 48 hrs 72 hrs 7 d 14 d
D9 Erythema a a a a a -
D13 Erythema a a a a a -
B7 Erythema a a a a a -
D9 Oedema 0 0 0 0 0 -
D13 Oedema 0 0 0 0 0 -
B7 Oedema 0 0 0 0 0 -

-: not examined

a: exposed skin areas stained in colour of the test substance, evaluation of erythema was not possible.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Not irritating.
Executive summary:

The irritant/corrosive potential of test substance was studied on the skin of rabbit in accordance with OECD guideline 404.

A volume of 0.5 g of test material was moistened with deionised water and subsequently applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches were held in place with semiocclusive dressing for the duration of the exposure period. After the exposure time of 4 hours, the dressing was removed and the exposed skin areas were carefully washed with water without altering the existing response or the integrity of the epidermis.

Evaluation of erythema was not possible in all three animals due to the intense colouration by test substance. However, no other inflammatory signs (oedema or eschar formation) became apparent within the observation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as "not irritating" to the skin.

Conclusion

Not skin irritating.