(2-hydroxyethyl)ammonium mercaptoacetate

Endpoint summary

Description of key information

MeaTG is toxic (Acute Tox 3) by ingestion. In contact with skin MEATG can cause irritating effects locally.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-02-04 - 1997-04-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Dept. of Environment, Lower Saxony, Germany

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Fa. Harlan Winkelmann GmbH, 33178 Borchen, Germany
Strain: Hsd/Dpb:WU
Weight range at study initiation: 213-298g (m), 179-205g (f)
Housing: collective housing up to a maximum of 3 animals per cage (Makrolon type III)Illumination: artificial lighting from 7.00 a.m.-7.00 p.m.
Temperature: 22±3 °C
Relative humidity: 30-70

Route of administration:

oral: gavage

Vehicle:

water

Doses:

140, 168, 202, 242, 290 and 348mg/kg of the test substance.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Clinical observations were conducted at regular intervals during the 14-day observation period.
Gross pathological examinations were performed immediately on animals found dead and at termination on day 14 on surviving animals.
Body weights were measured at days 0, 7 and 14.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

318 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

181 mg/kg bw

Based on:

test mat.

Mortality:

19 of 42 animals died pre-terminally.

Clinical signs:

other: Severe dose-dependent clinical signs were observed. The most striking findings were reduced activity, squatting position, abnormal galt and abnormal body posture, decreased body tone and decreased respiratory rate.

Gross pathology:

Gross pathological examinations on day 14 post administration (terminal necropsy) revealed no test article-dependent findings. However, animals found dead showed alterations, which were considered to be test article-related.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

MeaTG can be classified as toxic (Acute Tox 3).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

181 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

the substance is not used in spray applications

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Additional information

Thioglycolic acid and its salts are toxic by oral administration. When expressed as thioglycolate anion, the LD₅₀ values of thioglycolic acid and its salts are more or less in the same dose range LD₅₀≥ 50 mg/kg a. i. thioglycolate.

Justification for classification or non-classification

Based on acute oral LD50 of 181 mg/kg bw in rats.

Classification:

Acute tox 3. H301. Toxic if swallowed.