fatty acid chloride, C12, reaction product with sodium glutamate and sodium hydroxide

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h/

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

1.11

Max. score:

2

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Results 8

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.