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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:
01 July - 04 July 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a cold dark place (prefabricated refrigerator, 8.6 to 11.4°C), protected from light, in a well-closed container.
- Stability of test article: stable for one year, at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Kbl:NZW [SPF]
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd., Japan
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.99 - 3.33 kg
- Housing: individual in cages, feeders were changed every week
- Diet: commercial diet RC4 (lot No. 140109, Oriental Yeast), ad libitum
- Water: tap water, ad libitum (analysis was performed)
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 - 22.4
- Humidity (%): 52 - 64
- Air changes (per hr): ≥ 8
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 01 July To: 04 July 2014

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
(the test item was moistened with distilled water (0.4 mL) prior to treatment to ensure good contact with the skin)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.45 x 2.45 cm² on dorsal skin
- Type of wrap if used: The treated skin was covered with a 2.45 cm² patch (lint, Hasegawamenkou), which was covered with a surgical tape (2 inches in width, TransporeTM, 3M). This patch was covered with a larger cotton lint and was then fixed to the dorsal with an elastic adhesive bandage (New-HALEXTM, Hasegawamenkou).

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with distilled water and tissue paper.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No skin reaction was observed at any of the test sites of the 3 animals throughout the observation period.
Other effects:
Mortality/Clinical signs:
No mortality or clinical signs of toxicity were observed until the end of the observation period.

Body weights:
All animals gained body weight during the study period.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
CLP: not classified