Acylation product between cocoyl chloride and aminoacids

Endpoint summary

Description of key information

2 GLP studies following OECD guidelines 404 and 405 were performed.
The registered substance is not irritating to the skin but is irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-06-03 to 2008-06-16

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste –F40260 Linxe)
- Age at study initiation: 11 to 12 weeks old.
- Weight: During the test, the animals weighed between 2.43 kg and 2.86 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 52%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
- Diet (e.g. ad libitum): freely (foodstuff (SDS –C15))
- Water (e.g. ad libitum): freely (tap-water from public distribution system)
- Acclimation period: minimal 5-day

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

the test item was
applied, as supplied, at a dose of 0.5 mL

Duration of treatment / exposure:

the test item was applied during 4 hours

Observation period:

1 hour and then 24, 48 and 72 hours after removal of the patch

Number of animals:

Three male

Details on study design:

The TI was exposed on an area of skin about 6 cm2.
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.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean score

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean score

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean score

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

other: not applicable

Remarks on result:

other: mean score

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

other: mean score

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

other: not applicable

Remarks on result:

other: mean score

Irritant / corrosive response data:

A well defined erythema associated with a very slight oedema was noted on the treated area, at the
reading time one hour. The oedematous reactions were totally reversible between D1 and D2, and the
erythematous reactions were totally reversible between D2 and D6.
On the cutaneous structure, a slight dryness was noted on the treated area, from D3 in two animals.
The skin recovered a normal aspect between D6 and D7.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE08086, according to the scales of interpretation retained:
- is slightly irritant to skin (PSi = 0.8) 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 phrases 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 LCE08086 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. A well defined erythema associated with a very slight oedema was noted on the treated area, at the reading time one hour. The oedematous reactions were totally reversible between D1 and D2, and the erythematous reactions were totally reversible between D2 and D6. On the cutaneous structure, a slight dryness was noted on the treated area, from D3 in two animals. The skin recovered a normal aspect between D6 and D7. The results obtained, in these experimental conditions, enable to conclude that the test item LCE08086 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 phrases 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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

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

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

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

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

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

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

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

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

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

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

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

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.

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Klimich 1 : the study was conducted according to OECD guideline 404, GLP study

 

Justification for selection of eye irritation endpoint:
Klimich 1 : the study was conducted according to OECD guideline 405, GLP study

Effects on eye irritation: irritating

Justification for classification or non-classification

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 1 “severely irritating to eyes, H318.

Indeed, eye irritation classification is based on a worst case assumption for the effects of 100% neat substance, based on the study results obtained on 30% substance solutions. The registered substance is an organic marketed or used in aqueous formulation, clear liquid form and yellow tint color at 20°C and 101.3kPa.