2-Butenoic acid, 3-[(1-carboxyethyl)amino]-, 1-ethyl ester, monopotassium salt, [S-(Z)]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted in compliance with GLP and according to the OECD guideline 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

32132-92-6

EC Number:

608-707-1

Cas Number:

32132-92-6

IUPAC Name:

32132-92-6

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: individually/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 adaption days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control site at the same animal

Amount / concentration applied:

500 mg/patch and animal
(4 g test item were mixed with 0.5 mL aqua ad iniectabilia, 562.5 mg of this paste was applied per animal (~ 500 mg test item/animal))

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Care was taken to avoid
abrading the skin. Only animals with healthy intact skin were used.
A dose of 500 mg was applied to the test site (area: approx. 6 cm2). Pulverised solids were moistured sufficiently with water or a suitable vehicle to
ensure good contact with the skin.
The test item was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin by means of a
semi-occlusive dressing (non-irritating tape) for the duration of the exposure period. The surrounding untreated skin served as a control.
Exposure time was four hours. During the exposure the animals were kept in comfortable restrainers.
No residual test item had to be removed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1-3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: 1-3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

There were no systemic intolerance reactions .

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg Ala-Dane salt (W)/patch and animal (semi-occlusive
condition) showed any substance related lesions 24, 48 and 72 hours after patch removaL

Executive summary:

Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg Ala-Dane salt (W)/patch and animal (semi-occlusive condition) showed any substance related lesions 24, 48 and 72 hours after patch removaL