Acylation product between cocoyl chloride and aminoacids

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-06-03 to 2008-06-16

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:

Reaction product of apple aminoacids and lauroyl chloride

EC Number:

918-984-3

Molecular formula:

not applicable

IUPAC Name:

Reaction product of apple aminoacids and lauroyl chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Constituent 3

Reference substance name:

2-methylpentane-2,4-diol

EC Number:

203-489-0

EC Name:

2-methylpentane-2,4-diol

Cas Number:

107-41-5

Molecular formula:

C6H14O2

IUPAC Name:

2-methylpentane-2,4-diol

additive 1

Reference substance name:

Tetrasodium ethylenediaminetetraacetate

EC Number:

200-573-9

EC Name:

Tetrasodium ethylenediaminetetraacetate

Cas Number:

64-02-8

Molecular formula:

C10H16N2O8.4Na

Test material form:

other: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste –F40260 Linxe)
- Age at study initiation: 11 to 12 weeks old.
- Weight: During the test, the animals weighed between 2.43 kg and 2.86 kg
- 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 52%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
- Diet (e.g. ad libitum): freely (foodstuff (SDS –C15))
- Water (e.g. ad libitum): freely (tap-water from public distribution system)
- Acclimation period: minimal 5-day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

the test item was
applied, as supplied, at a dose of 0.5 mL

Duration of treatment / exposure:

the test item was applied during 4 hours

Observation period:

1 hour and then 24, 48 and 72 hours after removal of the patch

Number of animals:

Three male

Details on study design:

The TI was exposed on an area of skin about 6 cm2.
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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean score

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean score

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean score

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

other: not applicable

Remarks on result:

other: mean score

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

other: mean score

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

other: not applicable

Remarks on result:

other: mean score

Irritant / corrosive response data:

A well defined erythema associated with a very slight oedema was noted on the treated area, at the
reading time one hour. The oedematous reactions were totally reversible between D1 and D2, and the
erythematous reactions were totally reversible between D2 and D6.
On the cutaneous structure, a slight dryness was noted on the treated area, from D3 in two animals.
The skin recovered a normal aspect between D6 and D7.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE08086, according to the scales of interpretation retained:
- is slightly irritant to skin (PSi = 0.8) 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 phrases 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 item LCE08086 was applied, as supplied, at the dose of 0.5 mL, 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. A well defined erythema associated with a very slight oedema was noted on the treated area, at the reading time one hour. The oedematous reactions were totally reversible between D1 and D2, and the erythematous reactions were totally reversible between D2 and D6. On the cutaneous structure, a slight dryness was noted on the treated area, from D3 in two animals. The skin recovered a normal aspect between D6 and D7. The results obtained, in these experimental conditions, enable to conclude that the test item LCE08086 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 phrases 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.