Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
January from 10th to 24th, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines. Justification for Read Across is detailed in the endpoint summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Adopted 17.7.1992
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Similar Substance 02
IUPAC Name:
Similar Substance 02

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England. The health of the animals was routinely examined for the main specific Pathogens by the breeder.
- Age at study initiation: healthy adult albino rabbits.
- Weight at study initiation: 3.8 - 4.1 kg
- Housing: individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions. Excrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spazialdiaten GmbH, Soest). Bedding was regularly spot-checked for contaminants as required by the Department of Laboratory Animal Services, and changed at least twice weekly.
- Diet: standard diet "Ssniff K4" (ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water (of drinking water quality), ad libitum.
- Acclimation period: prior to use the animals were acclimatized for approximately one week in the animal room.
- Health control: no vaccinations or treatment with antibiotics were performed prior to receipt of the animals, or during the acclimatization phase or study period. If females were used they were nulliparous and not pregnant. The animals were examined one day prior to the start of the
study to establish that they were biologically normal; only animals not exhibiting any alterations to skin or eyes were used.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 1.5 °C (higher when ambient temperature over 24 °C.
- Humidity: 50 - 70 %
- Air changes: 12 - 15 times per hour.
- Photoperiod: 12 hours light/dark cycle, artificial illumination from 6 a.m. to 6 p.m.; approx. 500 Lux.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
500 ng of the pulverized test substance were moistened with deionised water (to ensure good contact with the skin) and subsequently applied to a hypoallergenic Hansamed - patch (Beiersdorf No. 2342 PV3).

CONTROL
A further patch was moistened with water. The patch prepared in this way was placed on the opposite dorso-lateral area of the trunk of each animal respect to the test item one.
Duration of treatment / exposure:
Four hours
Observation period:
14 days
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: approximately 24 hours before the test, fur was shorn from the dorso-lateral area of the trunk (6 x 6 cm) of each of the rabbits (equipment: electric hair clipper). Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used.

REMOVAL OF TEST SUBSTANCE
- Washing: the exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epideinis. The contralateral skin area not treated with test substance be served as control.
- Time after start of exposure: 4 hours

SCORING SYSTEM
For each animal the Draize scores recorded approx. 24, 48, and 72 hours after application were recorded.

Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (R) to slight eschar formation (S) (injuries in depth): 4R or 4S

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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Results
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
other: mean at 24, 48 and 72 hrs
Score:
< 2.3
Reversibility:
fully reversible
Irritant / corrosive response data:
Evaluation of skin erythema was not possible in all three animals due to the intense colouration by the test substance.
Nevertheless, no other inflammatory signs (eschar or oedema 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'.

Any other information on results incl. tables

Individual findings

Animals N. Body weight Draize grade after
1 h 24 h 48 h 72 h 7 d 14 d
E O E O E O E O E O E O
E2 4.1 kg a 0 a 0 a 0 a 0 a 0 - -
F16 3.8 kg a 0 a 0 a 0 a 0 a 0 - -
G9 3.8 kg a 0 a 0 a 0 a 0 a 0 - -

E: Erythema

O: Oedema

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Not irritating
Executive summary:

Tests for the determination of irritant/corrosive effects of the substance on skin of albino rabbits were conducted in accordance with the OECD Guidelines Nos. 404. The albino rabbit is recommended as the preferred species in the guideline.

Evaluation of skin erythema was not possible in all three animals due to the intense colouration by the test substance. Nevertheless, no other inflammatory signs (eschar or oedema 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 irritating