Sodium 5-oxo-1-palmitoyl-L-prolinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27.May.2008-17.June.2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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:

Sodium 5-oxo-1-palmitoyl-L-prolinate

EC Number:

261-406-3

EC Name:

Sodium 5-oxo-1-palmitoyl-L-prolinate

Cas Number:

58725-33-0

Molecular formula:

C21H38NNaO3.Na

IUPAC Name:

sodium (2S)-1-hexadecanoyl-5-oxopyrrolidine-2-carboxylate

Test material form:

liquid

Details on test material:

• Sponsor’s identification: LCA08009 • Date received : 14 May 2008
• Container : plastic flask (n=1) • Form : liquid
• Quantity : 142.44 g (container + contents) • Colour : brown
• Batch n° : LCA08009 • Storage : room temperature
• Production date: - • Expiry date: -
• CAS No: - • Purity: 30% It was identified under the code number: PH-08/0227.

The test item was considered as 100% for the study.
Informations concerning the identity, purity and stability of the test item are the responsibility of the Sponsor. A safety data sheet and an information data sheet concerning the test item were provided by the study monitor.

Specific details on test material used for the study:

Sponsor's identification: LCA08009
Date received: 14 May 2008
Container : plastic flask (n-1)
Form: liquid
Quantity : 142.44 g (container + contents)
Colour : brown
Batch no : LCA08009
Storage : room temperature
Purity: 30%
It was identified under the code number: PH-08/0227.
The test item was considered as 100% for the study.
Informations concerning the identity, purity and stability of the test item are the responsibility of the Sponsor. A safety data sheet and an information data sheet concerning the test item were provided by the study monitor.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals
Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste - F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animals weighed between 2,50 kg and 3.22 kg. At the beginning of the test, the animals were l l to 12 weeks old.

Housing
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature: between 19°C and 23°C - relative humidity: between 39% and 53% - lighting time: 12 hours daily - rate of air exchange: at least ten changes per hour

Food and drink
Drinking water (tap-water from public distribution system) and foodstuff (SDS-C15) were supplied freely, Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B).

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 g of the test item, as supplied

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.

Number of animals:

3
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first animal, two additional animals were treated.

Details on study design:

Approximately 24 hours before the test, the rabbits backs and flanks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm.
As no tissue destruction was noted after a treatment during 3 minutes and 1 hour, the test item was applied, as supplied, at a dose of 0.5g, on an undamaged skin area of one flank of each animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water, On the opposite flank an untreated area was served as the control. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.7

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible

Irritant / corrosive response data:

A well defined erythema associated with a slight oedema was noted, on the treated area, 24 hours after the test item application. The oedematous reactions were totally reversible between D5 and D6 and the erythematous reactions were totally reversible at D6. On the cutaneous structure, a dryness was noted on the treated area, from D3 in two animals and from D4 in the last one. A slight dryness was still noted at the end of the observation time (D14) in the three animais.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item LCA08009, according to the scales of interpretation retained:
- is irritant to skin (PSi = 3.8) according to the classification established in the Journal Officiel de la
République Francaise dated February 21, 1982,
- and, must be classified R38 “irritating to skin', according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The item must be characterised by the symbol “Xi' and the warning label “irritant”. In accordance with the Globally Harmonized System (COMC2007)355 final), the test item must not be classified in category2 “irritant'. No signal word and hazard statement are required.

Executive summary:

The test item LCA08009 was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C. D. guideline n° 404 dated April 24", 2002 and the test method B.4 of the directive n° 2004/73/EC.

 

A well defined erythema associated with a slight oedema was noted, on the treated area, 24 hours after the test item application. The oedematous reactions were totally reversible between D5 and D6 and the erythematous reactions were totally reversible at D6, On the cutaneous structure, a dryness was noted on the treated area, from D3 in two animals and from D4 in the last one. A slight dryness was still noted at the end of the observation time (D14) in the three animals.

 

The results obtained, in these experimental conditions, enable to conclude that the test item LCA08009 must be classified R38 “irritating to skin', according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The item must be characterised by the symbol “Xi' and the warming label “irritant”, In accordance with the Globally Harmonized System (COMC2007)355 final), the test item must not be classified in category 2 “irritant'. No signal word and hazard statement are required.