Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 December 2011 to 09 December 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF 2-1-4

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts

EC Number:

916-533-5

Molecular formula:

R-C6H6NO5Na2, R-C6H7NO5Na R: Coco fatty acid residue

IUPAC Name:

Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: White to pale yellow powder with a slightly characteristic odour.
- Storage condition of test material: room temperature (15-25 ºC) in the dark.
- pH: 6.5.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 weeks old males.
- Weight at study initiation: 3120 – 3146 g
- Housing: Individually in metal wire rabbit cages.
- Diet: Commercial feed, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 13 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.1 to 20.7 °C
- Humidity (%): 24 to 60 %
- Air changes (per hr): 15 to 20 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day, from 06:00 to 18:00 hours.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after treatment.

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: A 6 cm² area on the back and flank of each animal.
- Type of wrap if used: A single layer of fine medical gauze (open-weave with large holes) of approximately 5 x 5 cm was placed over the application area. The appropriate amount of test material was carefully spread over the application area (the gauze helped maintain the test item in place). Three more layers of gauze were placed over the test material. These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the moistened test material and the shaved skin. The entire trunks of the animals were wrapped with plastic wrap, kept in place with medical elastic tubing.

REMOVAL OF TEST SUBSTANCE
- Washing: The test material was removed with water at body temperature.
- Time after start of exposure: 4 hours.

OBSERVATIONS
- Dermal reaction: Animals were examined for signs of erythema and edema at 60 minutes and then at 24, 48 and 72 hours after patch removal. Animals were observed for a sufficient amount of time to assess reversibility of any observed effects.
- Clinical signs: Recorded daily.
- Body weights: Recorded at the beginning and at termination of the experiment.

SCORING SYSTEM: Dermal reactions were scored according to the Draize scale (1959), see Table 1.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

8

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

- One hour after patch removal: Very slight erythema (score 1) was observed in two animals and very slight edema (score 1) was noted in one animal.
- 24, 48 and 72 hours after patch removal: There were no observed clinical signs noted on the skin of the treated animals.
- As no clinical signs were observed the study was terminated after the 72 hours observation.

Other effects:

- Mortality: None observed during the study.
- Clinical: No treatment related clinical signs noted.
- Bodyweights: There was no effect of treatment on body weight. Body weights measured between 3184 and 3197g at termination.

Any other information on results incl. tables

Table 2: Erythema Formation Results

Animal No.	1 Hour	24 Hours	48 Hours	72 Hours
1	0	0	0	0
2	1	0	0	0
3	1	0	0	0
Total	2	0	0	0

 

Table 3: Edema Formation Results

Animal No.	1 Hour	24 Hours	48 Hours	72 Hours
1	0	0	0	0
2	1	0	0	0
3	0	0	0	0
Total	1	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Very slight erythema (score 1) was observed in two animals and very slight edema (score 1) was noted in one animal one hour after application of the test material. By 24 hours all effects were fully reversible. Under the conditions of the test, the test material was determined to be non-irritating.

Executive summary:

The potential for the test material to cause skin irritation was determined in vivo, in a study conducted under GLP conditions and in line with OCED 404, EU Method B.4, EPA OPPTS 870.2500 and Japanese MAFF (2-1-4). The test material was administered to three male New Zealand White rabbits and occluded for 4 hours, after which the test material was removed by washing with water. Dermal reactions were assessed at 1, 24, 48 and 72 hours post removal. Clinical observations were recorded daily and bodyweights were measured at initiation and termination.

Very slight erythema (score 1) was observed in two animals and very slight edema (score 1) was noted in one animal one hour after application of the test material. By 24 hours all effects were fully reversible. Under the conditions of the study, the test material was determined to be non-irritating.