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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-06-09 to 2008-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

Test item
Sponsor's identification: LCE08088
Container: plastic flask (n=1)
Quantity: 1056,60 g (container + contents)
Batch: 0801000014
Form: liquid
Colour: yellow
Storage: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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 animais weighed between 3.04 kg and 3.71 kg. At the beginning ofthe test, the animals were 13 weeks old.

Housing
The animals were kept in an individual box installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 24°C
- relative humidity : between 38% and 64%
- 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 - C 15) were supplied freely, Microbiologicai 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

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye as control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Until natural elimination

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is termined. In case of persistent reactions, additional observations can be carried out from D4 to D21 in order to determine the reversibility character of the lesions observed.

Number of animals or in vitro replicates:

3

Details on study design:

0.1 mL of the test item vas instilled, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
lnitially, a single animal vas treated. Alter consideration of the ocular responses produced in the fïrst treated animal at D14, two additionai animals
were treated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Irritant / corrosive response data:

The ocular reactions observed during the study have been moderate, and totally reversible in the three animals:
- at the conjuctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D8 and D9.
- at the corneal level: a moderate opacity, registered 24 hours alter the test hem instillation and totally reversible between D9 and D 17,
- at the iris level: a congestion noted 1 hour and 24 hours alter the test item instillation in two animals and between 1 hour alter the test hem instillation and D6 in the Iast animal.

Applicant's summary and conclusion

Interpretation of results:

Category II

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item LCE08088:
- is highly irritant for the eye (Max. 0.1 = 54.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, must be classified R36 “irritating to eyes” according to the criteria for the classification, packaging and labelling of dangerous substances in
compliance with the E.E.C. Directive n° 67/548, 200 1/59 and 99/45. The test item must be characterised by the symbol “Xi” and the warning label
“irritant “.
In accordance with the Globally Harmonized System (COM(2007)3 55 final), the test item must be classified in category 2 “irritating to eyes”. The
signal word and hazard statement H319 “Causes serious eye irritation” are required.

Executive summary:

The test item LCE08088 was instilled as supplied, at the dose of 0.1 mL into the eye of three New Zealand rabbits, The experimental protocol was established on the basis of the official method as defined in the O.E. C.D. guideline n° 405 dated April 24°, 2002 and the test method B. 5 of the directive 2004/73/EC.

The ocular reactions observed during the study have been moderate, and totally reversible in the three animals: - at the conjunctivae level: a moderate redness, noted 1 hour afler the test item instillation and totally reversible between D9 and D11, associated with a moderate chemosis, noted 1 hour afler the test item instillation and totally reversible between D8 aud D9; - at the corneal level: a moderate opacity, registered 24 hours afler the test hem instillation and totally reversible between D9 and Dl7, - at the Iris level: a congestion noted 1 hour and 24 hours afler the test hem instillation in two animals and between 1 hour afler the test item instillation and D6 in the last animal.

In conclusion, the result obtained, under these experimental conditions, enables to conclude that the test item LCE08088 must be classified R36 “irritating to eyes” according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/5 9 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 be classifïed in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.