Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

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 2008-06-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP 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)

Remarks:

2008-07-16

Test material

Test material information

Constituent 1

Reference substance name:

Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

EC Number:

500-500-3

EC Name:

Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Cas Number:

161074-67-5

Molecular formula:

Not applicable

IUPAC Name:

Acylation product between lauroyl chloride and amino acids

Test material form:

liquid

Details on test material:

• Sponsor’s identification: LCE08088
• Container : plastic flask (n=1)
• Quantity : 1056.60 g (container + contents)
• Batchn° :0801000014
• Production date: 10 January 2008
• CASNo:It was identified under the code number: Pif-08/0226.
• Date reeeived : 22 May 2008
• Form: liquid
• Colour : yellow
• Storage : room temperature
• Retest date: 09 January 2011
• Purity: 28,7% dry extract

Specific details on test material used for the study:

Sponsor's identification: LCE08088
Container: plastic flask
Quantity: 1056,60 g
Batch: 0801000014
Form: liquid
Colour: yellow
Storage: room temperature

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 Liuxe). They were kept during a minimal 5-day aclimatisation period. During the test, the animals weighed between 2.33 kg and 3.08 kg. At the beginning of the test, the animais were 11 to 12 weeks old.

Housing
Bach animal was kept in an individual box installed in conventional air conditioned animal husbanding; the environmentai conditions were:
- temperature : between 19°C and 23°C
- relative huniidity : between 39% and 52%
- lighting time: 12 hours daiiy
- 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.
Microbiologieal and chemical analyses of the water were carried ont once every six months by the
Institut Européen de l’Environnement de Bordeaux (1.E.E.B.).

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Other side

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1 hour, 24, 48 and 72 hours after patch removal

Number of animals:

3

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.
As no tissue destruction vas noted afler a treatment during 3 minutes and during 1 hour, the test item was applied, as supplied, al a dose of 0.5 mL, on an undamaged skin area of one flank of one animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape. Afler the removal of the patch, the treated area ;vas rinsed with distilled water.
On the opposite flank an untreated area vas served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produeed in the first treated animal, two additional animais 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

Max. score:

2

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.5

Max. score:

2

Irritant / corrosive response data:

It was noted, 24 hours after the test item application, on the treated area, a well defined erythema associated with a slight oedema. The oedematous reactions were totally reversible between D2 and D6 and the erythematous reactions were totaly reversible between D3 and D6.
On the cutaneous structure, a slight dryness vas noted on the treated area, between D3 and D8 in two animais. In the last animal, a dryness vas registered between D3 and D14 (end of tire observation time).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item LCEO8O88, according to the scales of interpretation retained:
- is irritant to skin (PSi 3.2) according to the classification established in the Journal Officiel de la République Française dated February 2], 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, 2 001/59 and 99/45. The item must ho cliaracterised by the symbol “Xi” and the warning label “irritant”.
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 LCEO8O88 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 cf the directive n° 2004/73/EC’.

It was noted, 24 hours afler the test item application, on the treated area, a well defined erythema associated with a slight oedema, The oedematous reactions were totally reversible between D2 and D6 and the erythematous reactions were totally reversible between D3 and D6. On the cutaneous structure, a slight dryness vas noted on the treated area, between D3 and D8 in two animals, In the last animal, a dryness was registered between D3 and D14 (end of the observation time).

The results obtained, in these experimental conditions, enable to conclude that the test item LCEO8O88 must be classffied 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, 2 001/59 and 99/45. The item must be characterised by the symbol “Xi” and the warning label “irritant”. In accordance with the Globally Harmonized System (COM(2007)355 fmal), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required.