reaction product of wheat aminoacids and lauryl chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.January.2008-03.March.2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD guideline

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:

acylation product between lauroyl chloride and amino acids

EC Number:

927-837-2

Molecular formula:

Not applicable

IUPAC Name:

acylation product between lauroyl chloride and amino acids

Test material form:

liquid

Specific details on test material used for the study:

Sponsor's identification: LCE07106
Container: plastic flask (n=1)
Quantity: 184.84 g (container + contents)
Batch n° 0715200018
Production date: 01 June 2007
Date received: 21 December 2007
Form: liquid
Coulour: yellow
Storage: Room temperature
Re-test: 31 May 2009

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals
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 1.87 kg and 2.72 kg. At the beginning of the test, the animals were 11-week
old.
Housing
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 20°C and 22°C
- relative humidity : between 40% and 57%
- lighting time: 12 hours daily
Food and drink
Drinking water (tap-water from public distribution system) and foodstuff 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)

Controls:

yes

Amount / concentration applied:

The test item LCE07106 was applied, as supplied, at the dose of 0.5 mL.

Duration of treatment / exposure:

during 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:

Treatment
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 cm2.
The test item was applied, as supplied, at a dose of 0.5 mL, 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.

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-72h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-72h

Score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-72h

Score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24-72h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24-72h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24-72h

Score:

0

Irritant / corrosive response data:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE07106, 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.

Any other information on results incl. tables

It was noted, 1 hour after the test item application, on the treated area, a very slight erythema associated with a very slight oedema in two animals. The oedematous reactions were totally reversible at D1 and the erythematous reactions were totally reversible at D2.

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
LCE07106, 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 item LCE07106 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.

It was noted, 1 hour after the test item application, on the treated area, a very slight erythema

associated with a very slight oedema in two animals. The oedematous reactions were totally reversible

at D1 and the erythematous reactions were totally reversible at D2.

The results obtained, under these experimental conditions, enable to conclude that the test item

LCE07106 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.