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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07.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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals
One male albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste –
F40260 Linxe). It was kept during a minimal 5-day acclimatisation period. During the test, the animal
weighed between 2.53 kg and 3.18 kg. At the beginning of the test, the animal was 11-week old.

Housing
The animal was kept in an individual box installed in conventional air conditioned animal husbanding;
the environmental conditions were:
- temperature : between 18°C and 22°C
- relative humidity : between 37% and 52%
- 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

Vehicle:
unchanged (no vehicle)
Controls:
yes
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
Number of animals or in vitro replicates:
One animal
Initially, a single animal was treated. After consideration of the ocular responses produced in the first
treated animal, two additional animals were not treated.
Details on study design:
0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye
remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first
treated animal, two additional animals were not treated.
Grading of reactions
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment.
NOTE :
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional
observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72h
Score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal #1
Time point:
other: 24-72h
Score:
1.3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24-72h
Score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Remarks:
lesion
Basis:
animal #1
Time point:
other: 24-72h
Score:
1
Reversibility:
not reversible
Irritation parameter:
other: Maximum ocular irritation index
Basis:
animal #1
Time point:
21 d
Max. score:
59
Remarks on result:
positive indication of irritation
Remarks:
Highly irritant according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992
Irritant / corrosive response data:
Taking into account the irreversibility of the reactions, the test item must be classified R41 "Risk of serious damage to eyes", in accordance with the
European regulation.

Any other information on results incl. tables

The ocular reactions observed during the study have been moderate and partially reversible:

- at the conjunctivae level: a moderate redness, registered 1 hour after the test item instillation and

totally reversible at D17, associated with a moderate chemosis, registered 1 hour after the test item

instillation and totally reversible at D7,

- at the corneal level: a moderate opacity, registered 1 hour after the test item instillation, and still

noted at the end of the observation time (moderate intensity),

- at the iris level: a congestion noted between D1 and D3.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item
LCE07106:
- is highly irritant for the eye (Max. O.I = 59) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- and, must be classified R41 "Risk of serious damage to eyes" taking into account the
irreversibility of the reactions, according to the criteria for the classification, packaging and labelling
of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. It
must be characterised by the symbol “Xi” and the danger label “irritant”.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be
classified in category 1 “Irreversible effects on the eye”. The signal word “Danger” and hazard
statement H318 “Causes serious eye damage” are required.
Executive summary:

The test item LCE07106 was instilled as supplied, at the dose of 0.1 mL into the eye of one New

Zealand rabbit. 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 24th, 2002 and the test method B.5 of the

directive 2004/73/EC.

The ocular reactions observed during the study have been moderate and partially reversible:

- at the conjunctivae level: a moderate redness, registered 1 hour after the test item instillation and

totally reversible at D17, associated with a moderate chemosis, registered 1 hour after the test item

instillation and totally reversible at D7,

- at the corneal level: a moderate opacity, registered 1 hour after the test item instillation, and still

noted at the end of the observation time (moderate intensity),

- at the iris level: a congestion noted between D1 and D3.

In conclusion, the result obtained, under these experimental conditions, enable to conclude that the test

item LCE07106 must be classified R41 "Risk of serious damage to eyes" taking into account the

irreversibility of the reactions, according to the criteria for the classification, packaging and labelling

of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. It

must be characterised by the symbol “Xi” and the danger label “irritant”.

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be

classified in category 1 “Irreversible effects on the eye”. The signal word “Danger” and hazard

statement H318 “Causes serious eye damage” are required.