Ammonium mercaptoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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:

Ammonium mercaptoacetate

EC Number:

226-540-9

EC Name:

Ammonium mercaptoacetate

Cas Number:

5421-46-5

Molecular formula:

C2H4O2S.H3N

IUPAC Name:

ammonium 2-sulfanylacetate

Details on test material:

- Name of test material (as cited in study report): Ammonium thioglycolate 71%
- Physical state: colourless liquid
- Analytical purity: 71.5%
- Impurities (identity and concentrations): Iron < 0.1 ppm
- Purity test date: 14.02.2003
- Lot/batch No.: 4676
- Storage condition of test material: at room temperature and under nitrogen gas
- Other: Source: Bruno Bock Chemische Fabrik GmbH & Co KG

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 309 ± 9 g for the males and 227 ± 4 g for the females
- Housing: single
- Diet (e.g. ad libitum): A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge,France), ad libitum
- Water (e.g. ad libitum): 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


IN-LIFE DATES: From: 11 March 2003 To: 25 March 2003

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: a dorsal area of the skin (approximately 5 cm x 6 cm for the females and 5 cm x 7 cm for the males)
- % coverage: approximately 10%
- Type of wrap if used: hydrophilic gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.64 mL/kg
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

2000 mg/kg of a 71,5% aqueous solution (equivalent to 1430 mg/kg of the active ingredient)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The animals were observed frequently during the hours following administration of the test itemfor detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
From day 2, any local cutaneous reaction was recorded.
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
The body weight gain of the treated animals was compared to that of CIT control animals with a similar initial body weight.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic necropsy examination:All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main morgans (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. Preservation of tissues: No organ samples were taken.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 430 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths were observed during the study.

Clinical signs:

other: No clinical signs were observed during the study.

Gross pathology:

No apparent abnormalities were observed at necropsy in any animals.

Other findings:

No cutaneous reactions were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is higher than 2000 mg/kg of a 71.5% aqueous solution (equivalent to 1430 mg/kg of the active ingredient)