(2-hydroxyethyl)ammonium mercaptoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-03-07 - 2003-08-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2-hydroxyethyl)ammonium mercaptoacetate

EC Number:

204-815-4

EC Name:

(2-hydroxyethyl)ammonium mercaptoacetate

Cas Number:

126-97-6

Molecular formula:

C2H7NO.C2H4O2S

IUPAC Name:

2-hydroxyethan-1-aminium 2-sulfanylacetate

Constituent 2

Reference substance name:

MEATG

IUPAC Name:

MEATG

Test material form:

solid - liquid: suspension

Details on test material:

- Physical state: colourless liquid
- Content: 83.4% MEATG in water
- Lot/batch No.: 4677
- Storage condition of test material: at room temperature and under nitrogen gas

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 331 ± 7 g for the males and 236 ± 8 g for the females
- Housing: single
- Food and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

The test item was placed directly on the clipped area of the skin. A hydrophilic gauze pad was then applied to the skin.
The test item and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test item by the animals.
No residual test item was observed on removal of the dressing.

Duration of exposure:

24 h

Doses:

The test item was applied undiluted at the dose-level of 2000 mg/kg, taking into consideration that its specific gravity was 1.25 g/mL. The volume of administration was therefore 1.6 mL/kg. The dose applied to each animal was adjusted according to body weight determined on the day of treatment.

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No clinical signs and no deaths were observed during the study.

Clinical signs:

other: No cutaneous reactions were observed.

Gross pathology:

No apparent abnormalities were observed at necropsy in any animal.

Any other information on results incl. tables

No clinical signs and no deaths were observed during the study. A reduced body weight gain was seen in all males and in 1/5 females between day 1 and day 8.

The body weight gain of the other animals was similar to that of historical control animals.

No cutaneous reactions were observed.

No apparent abnormalities were observed at necropsy in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the dermal LD50 of MeaTG 83% is higher than 2000 mg/kg in rats.