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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 October 2011 to 02 November 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:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF 2-1-2

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adults.
- Weight at study initiation: 227 - 254 g.
- Housing: Individually in polypropylene/polycarbonate cages.
- Diet: Complete feed for rats and mice, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15-20 air charges per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, from 06:00 to 18:0 hours.

IN-LIFE DATES: From: 19 October 2011 To: 02 November 2011

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The back of each animal.
- % coverage: The test material was applied to the shaved skin. the test material was moistened with water and distributed as evenly as possible over an area of approximately 10 % of the total body area.
- Type of wrap if used: A gauze pad was placed over the applied test material. The gauze pad was fixed with a hypoallergenic plaster on the skin of the animals. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: After exposure the treated area of skin was washed with water at body temperature.
- Time after start of exposure: 24 hours.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
> Clinical Observations: Performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Bodyweights: Measured prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed after the treatment with the test material or during the 14-day observation period. No local signs were observed after the treatment with the test material or during the 14-day observation period.

Gross pathology:

There was no evidence of the observations at a dose level of 2000 mg/kg bw at necropsy.

Other findings:

No local dermal signs were observed after treatment with the test material.

Any other information on results incl. tables

Table 1: Male Bodyweight Data (g)

Animal No.	Body weight (g) Days			Body Weight Gain (g)
	0	7	14	0-7	7-14	0-14
9407	243	297	340	54	43	97
9408	254	307	351	53	44	97
9409	245	299	348	54	49	103
9410	243	291	339	48	48	96
9411	237	289	340	52	51	103
Mean	244.4	296.6	343.6	52.2	47.0	99.2
Standard Deviation	6.1	7.1	5.5	2.5	3.4	3.5

 

Table 2: Female Bodyweight Data (g)

Animal No.	Body weight (g) Days			Body Weight Gain (g)
	0	7	14	0-7	7-14	0-14
9412	229	240	252	11	12	23
9413	237	247	280	10	33	43
9414	227	238	252	11	14	25
9415	237	263	263	26	0	26
9416	245	257	269	12	12	24
Mean	235.0	249.0	263.2	14.0	14.2	28.2
Standard Deviation	7.2	10.8	11.9	6.7	11.9	8.3

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, no signs of systemic or local toxic effects were observed during the 14 day observation period. The acute dermal LD50 of the test material was determined to be greater than 2000 mg/kg bw in both male and female rats.

Executive summary:

The acute dermal toxicity of the test material was assessed in study performed under GLP conditions and in line with OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 2-1-2. A limit test was carried out at 2000 mg/kg bw in both sexes (5 rats/sex). The test material was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period. After the exposure period the residual test material was removed by washing the area with water. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).

Under the conditions of the study no mortality was observed at 2000 mg/kg bw. Bodyweights showed normal weight gain. No clinical signs of systemic or local toxic effects were observed during the 14 day observation period. Additionally there was no evidence of treatment related findings at necropsy. Accordingly the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.