Acylation product between cocoyl chloride and aminoacids

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 2008-06-25

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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste– F40260 Linxe)
- Age at study initiation: 12 to 13 weeks
- Weight during the test: 2.53 kg and 3.22 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 63%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
- Diet (e.g. ad libitum): supplied freely (foodstuff (SDS- C15)
- Water (e.g. ad libitum): supplied freely (tap-water from public distribution system)
- Acclimation period: minimal 5-day

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of the test item was instilled, as supplied

Duration of treatment / exposure:

9 days

Observation period (in vivo):

1hour, 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

Three female

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 at D7, two additional animals were treated

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment, according to the numerical evaluation given below.
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.


EVALUATION OF OCULAR IRRITATION
Eye examinations are carried out using the scale of lesion scores in the following order:

CHEMOSIS (A)
• No swelling ................................................................................................................................... 0
• Slight swelling, including the nictitating membrane................................................................1
• Swelling with eversion of the eyelid ...........................................................................................2
• Swelling with eyelid half-closed ................................................................................................. 3
• Swelling with eyelid more than half-closed .............................................................................. 4

DISCHARGE (B)
• No discharge ................................................................................................................................. 0
• Slight discharge (normal slight secretions in the inner corner not to be
taken into account) .......................................................................................................................... 1
• Discharge with moistening of the eyelids and neighbouring hairs....................................... 2
• Discharge with moistening of the eyelids and large areas around the eye ......................... 3

REDNESS (C)
• Blood vessels normal .................................................................................................................... 0
• Vessels significantly more prominent than normal ................................................................. 1
• Vessels individually distinguishable with difficulty
- Generalised red coloration........................................................................................................... 2
- Generalised deep red coloration ................................................................................................ 3

IRIS (D)
• Normal ............................................................................................................................................ 0
• Iris significantly more wrinkled than normal, congestion,
swelling of the iris which continues to react to light, even slowly............................................. 1
• No reaction to light, haemorrhage, significant damage
(any or all of these characteristics)................................................................................................ 2

CORNEA: DEGREE OF OPACITY (E)
• No modification visible either directly or after
instillation of fluorescein (no loss of glint or polish) .................................................................... 0
• Translucent areas (diffuse or disseminated), iris details clearly visible .................................. 1
• Easily identifiable translucent area, iris details slightly obscured............................................. 2
• Opalescent area, no iris details visible, pupil outline scarcely distinguishable ...................... 3
• Total corneal opacity, completely obscuring the iris and pupil................................................. 4

CORNEA: EXTENT OF OPACITY (F)
• Opaque area present but covering one quarter or less.............................................................. 1
• Between one quarter and half........................................................................................................... 2
• Between half and three quarters ..................................................................................................... 3
• Between three quarters and the entire surface.............................................................................. 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Redness

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Reversibility:

not reversible

Remarks:

within 72h

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 72h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Redness

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

not fully reversible within: 72h

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Reversibility:

not reversible

Remarks:

within 72h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Redness

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

not fully reversible within: 72h

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

not fully reversible within: 72h

Irritant / corrosive response data:

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 after the test item instillation and totally
reversible between D7 and D9, associated with a moderate chemosis, noted 1 hour after the test item
instillation and totally reversible between D3 and D4;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally
reversible between D3 and D7.

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE08086:
- is moderately irritant for the eye (Max. O.I = 28) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- and, must not be classified 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. No
symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be
classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319
“Causes serious eye irritation” are required.

Executive summary:

The test item LCE08086 was instilled as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 mL. 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 totally reversible in the three animals: - at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D7 and D9, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D3 and D4; - at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between D3 and D7. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCE08086 must not be classified 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. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required