trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-21 to 2008-03-03

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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:

trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline

EC Number:

255-490-0

EC Name:

trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline

Cas Number:

41672-81-5

Molecular formula:

C37H69NO5

IUPAC Name:

1-palmitoyl-4-(palmitoyloxy)-L-proline

Details on test material:

Form : powder
Storage : Room temperature
Re-test date: 30 August 2010
Batch n° : 0724300010

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three male 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 2.47 kg and 2.76 kg. At the beginning of the test, the animals were 11-week
old.
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 21°C
- relative humidity : between 43% and 55%
- lighting time: 12 hours daily

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes

Amount / concentration applied:

The test item LCA07033 was applied at the dose of 0.5 g, under semi-occlusive dressing.

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

Primary skin irritation (PSi)=0
1 hour after removal of the patch: 1/3 animals with skin reaction (very slight erythema)
24 hours after the removal of the patch: 0/3 animals with skin reaction
72 hours after removal of the patch: 0/3 animals with skin reaction

Any other information on results incl. tables

The test product was applied, as supplied, at the dose of 0.5 g, 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 24th, 2002 and the test method B.4 of the directive n° 2004/73/EC. It was only noted a very slight erythema in one animal, at the reading time 1 hour. The results obtained, under these experimental conditions, enable to conclude that the test item LCA07033 must not be classified, 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. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required.

The result obtained, in these experimental conditions, enable to conclude that the test product, according to the scales of interpretation retained:

- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de

la République Française dated February 21st, 1982,

- and, must not be classified, 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.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the product, according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de
la République Française dated February 21st, 1982,
- and, must not be classified, 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. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be
classified in category 2 “irritant”. No signal word and hazard statement are required.

Executive summary:

The test product was applied, as supplied, at the dose of 0.5 g, 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 24th, 2002 and the test method B.4 of the directive n° 2004/73/EC. It was only noted a very slight erythema in one animal, at the reading time 1 hour. The results obtained, under these experimental conditions, enable to conclude that the test item LCA07033 must not be classified, 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. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required.

The result obtained, in these experimental conditions, enable to conclude that the test product, according to the scales of interpretation retained:

- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de

la République Française dated February 21st, 1982,

- and, must not be classified, 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.