Registration Dossier

Administrative data

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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Dept. of Environment, Lower Saxony, Germany
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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.
Body weight:
Weight gains were normal in all surviving animals.
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
181 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
Test type:
fixed dose procedure
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
No cutaneous reactions were observed.
Body weight:
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 CIT historical control animals.
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:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Thioglycolic acid and its salts are toxic by oral administration. When expressed as thioglycolate anion, the LD50values 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 toxicity data in rats.

Classification:

DSD: T, R25. Toxic if swallowed.

EU-GHS: Acute tox cat. 3. H301. Toxic if swallowed.