Sodium 4-(4-substitutedanilino)-4-substituedbut-2-enoate

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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 or test system 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

Results

Results 1

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

Results 2

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