L-Proline, 4-(phenylthio)-, (4S)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2S,4S)-4-(phenylsulfanyl)pyrrolidine-2-carboxylic acid

EC Number:

617-252-8

Cas Number:

81653-77-2

Molecular formula:

C11H13NO2S

IUPAC Name:

(2S,4S)-4-(phenylsulfanyl)pyrrolidine-2-carboxylic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Charles River Deutschland, D-88353 Kisslegg
Sex: female
Body weight at thè beginning of thè study: 3.9, 5.5, 5.2 kg
Age at thè beginning of thè study: approximately 13 weeks old
Housing and Feeding Conditions
Semi-barrier in an air conditioned room
- Temperature: 18 ± 3°C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatisation period (at least 5 days)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g per test site

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal

Number of animals:

3

Details on study design:

Preparation of the Animals
Approximately 22 hours before the test, the fur from animai no. 1 and approximately 23 hours from animals no. 2 and 3 was removed from the dorsal area of the trunk by using an electronic clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
Exposur e Period
The test item was held in contact with thè skin throughout a 4-hour period.
At the end of the exposure period, residuai test item was not removed.
Confirmatory Test
As a corrosive effect was not observed in thè initial test, two additional animals, each with one patch, were used for an exposure period of 4 hours.
Observation Period
All of the animals were observed for 72 hours after the patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Other effects:

There were no significant body weight changes during thè contact and observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of the present study, it can be stated that the test item showed neither irritant nor corrosive effects.

Executive summary:

The test for acute dermal irritation/corrosion is performed on the rabbit according to the OECD guideline 404.

Under the conditions of the present study, it can be stated that the test item showed neither irritant nor corrosive effects.