Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation / corrosion, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
Justification is provided in the separate statement.
Reason / purpose for cross-reference:
assessment report
Reason / purpose for cross-reference:
assessment report
Reason / purpose for cross-reference:
assessment report
Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation property of the registration substance sodium N-lauroyl glutamate is derived based on the read-across to Sodium N-cocoyl glutamate and Sodium N-cocoyl glycinate. No skin irritating property can be reliably derived.
Executive summary:

The skin irritation property of the registration substance, sodium N-lauroyl glutamate, is derived based on the read-across to sodium N-cocoyl glutamate and sodium N-cocoyl glycinate.

The registration substance and the read-across sources are amides of fatty acids and amino acids and can be characterized as "N-fatty acyl amino acids", of which endogeous occurence and metabolism are known. Based on the comparable chemical structure, comparable phys-chem data and expected comparable metabolism, these compound are likely exhibit comparable toxicity profiles.

Sodium N-cocoyl glutamate is investigated for its skin irritation property according to the OECD 404. 0.5 ml of the test material was applied to the rabbit skin semi occusively for 4 hours. Slight erythema was found in two animals out of three and these effect were reverseible. Sodium N-cocoyl glutamate is not skin irritating.

Sodium N-cocoyl glycinate is investigated for its skin irritation property according to the OECD 404. 0.5 ml of the test material was applied to the rabbit skin semi occusively for 4 hours. Well-defined and mild erythea and edema were found in all treated animals and these effects were reversible. Sodium N-cocoyl glycinate is not skin irritating.

Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the OECD 439. 10 mg of test compound was applied topically to the EPISKIN-SM tissue for 15 minutes followed by a 42 hour post incubation period and immediate determination of cytotoxic effects via MTT reduction assay. No significant effect on the cell viability was obtained. Sodium N-cocoyl glycinate is not skin irritating.

Likewise the registration substance, sodium N-lauroyl glutamate is considered as not skin irritating.

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Sodium cocoyl glycinate (SCG) [INCI]
IUPAC Name:
Sodium cocoyl glycinate (SCG) [INCI]

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 weeks (males, females)
- Weight at study initiation: 2.2 kg (male); 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark / light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / animal
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hour
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- % coverage: 100
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Irritation scoring according to Council Regulation (EC) No 440/2008

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h/
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
1.11
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Other effects:
Scaling noted

Any other information on results incl. tables

Table: Skin irritation scores

Observation Time

Erythema

Oedema

Animal 1

Animal 2

Animal 3

Animal 1

Animal 2

Animal 3

1h

2

2

2

1

2

1

24h

2

2

2

1

2

1

48h

1

2

2

1

1

1

72h

1

1

2

1

1

1

7 day

0

1

0

0

0

0

10 day

0

0

0

0

0

0

14 day

0

0

0

0

0

0

Mean of 24/48/72h

1.33

1.67

2

1

1.33

1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the Guideline OECD 404. It is not skin irritating.
Executive summary:

Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the OECD 404. 0.5 ml of the test material was semi occusively applied to the clipped skin area of rabbits for 4 hours. Three animals were treated. Mild erythema and edema was found in all treated animals and these effects disappeard within 14 days. Sodium N-cocoyl glycinate is not skin irritating.