reaction product of wheat aminoacids and lauryl chloride

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.January.2008-03.March.2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals
Three male 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
animals weighed between 1.87 kg and 2.72 kg. At the beginning of the test, the animals were 11-week
old.
Housing
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 20°C and 22°C
- relative humidity : between 40% and 57%
- 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.).

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The test item LCE07106 was applied, as supplied, at the dose of 0.5 mL.

Duration of treatment / exposure:

during 4 hours

Observation period:

The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.

Number of animals:

3
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first animal, two additional animals were treated.

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.
The test item was applied, as supplied, at a dose of 0.5 mL, on an undamaged skin area of one flank of
each animal, during 4 hours. 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.
On the opposite flank an untreated area was served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the
first treated animal, two additional animals were treated.

Grading of reactions
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-72h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-72h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-72h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24-72h

Score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24-72h

Score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24-72h

Score:

0

Irritant / corrosive response data:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE07106, according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0) 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 phrase 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.

It was noted, 1 hour after the test item application, on the treated area, a very slight erythema associated with a very slight oedema in two animals. The oedematous reactions were totally reversible at D1 and the erythematous reactions were totally reversible at D2.

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE07106, according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0) 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 phrase 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 LCE07106 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.

It was noted, 1 hour after the test item application, on the treated area, a very slight erythema

associated with a very slight oedema in two animals. The oedematous reactions were totally reversible

at D1 and the erythematous reactions were totally reversible at D2.

The results obtained, under these experimental conditions, enable to conclude that the test item

LCE07106 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 phrase 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

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 2

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

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)

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

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.).

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion

The results obtained, under these experimental conditions, enable to conclude that the test item

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 phrase 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.

Eye irritation

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

item 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.