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Administrative data

Description of key information

CaTG is toxic by ingestion. In contact with skin and by inhalation CaTG can cause irritating effects.

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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study (short report)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
160, 200, 250, 320, 400, 450, 500 and 640 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
352 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
245 mg/kg bw
Based on:
act. ingr.
Gross pathology:
Exitus within 24 h, therefore no section conducted.
Other findings:
First exitus after 3 hours, last exitus after 24 hours.
Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Toxic if swallowed. OECD GHS criteria Category 3 (50-300 mg/kg bw)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
245 mg/kg bw

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-11-07 - 2008-05-28
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Federal State Authority, North Rhine-Westphalia, Germany
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
clean air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
CaTG aerosol sampled by gravimetric analysis was eluted from the filter and then determined by HPLC.
Duration of exposure:
4 h
Concentrations:
Four groups of rats were nose-only exposed to a solid aerosol in concentrations of 483, 1022, 2208, and 2729 mg/m3 air.
No. of animals per sex per dose:
5
Control animals:
yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 729 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC0
Effect level:
483 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
Mortality did not occur in any concentration-dependent manner. The particle size distribution was not essentially different between groups with mortality. The LC50 was greater than 2729 mg/m3. No animals died at 483 mg/L (0/10 animals, 4 h exposure).
Clinical signs:
other: The signs of importance for the toxicological evaluation of the highest dose group can be qualitatively described as follows: bradypnea, labored breathing patterns, stridor, motility reduced, flaccidity, piloerection, hair-coat ungroomed, nose reddened, a
Body weight:
Comparison between control and exposure groups revealed consitent, concentration-dependent decrease in body weights.
Gross pathology:
Findings of toxicological importance and for toxicological evaluation can be summarized as follows:
Animals sacrificed at the end of the observation period: The macroscopic findings were essentially indistinguishable amongst exposure and control groups.
Animals succumbing during the observation period: nose-/muzzle area: red encrustations with somewhat occlude nostrils, trachea with white foamy content, lung less collapsed and with dark-red discolorations, gastrointestinal tract: black-red focal discolorations of mucosa and dark-red content in the lumen.
Other findings:
Statistical comparisons between the control and the exposure groups revealed significant changes in body temperature in groups 3 and above.
Interpretation of results:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The aerosolized CaTG (solid aerosol, dry powder) proved to have a low acute inhalation toxicity in rats. Thus, the LC50 is greater than 2729 mg/m3. However, the observed signs demonstrated that the respirable dust of this test substance (in its micronized form) may cause marked and prolonged respiratory tract irritation.
Executive summary:

A study on the acute inhalation toxicity of CaTG on rats has been conducted in accordance with OECD Guideline No. 403. Mortality occurred in a few rats at 1022 mg/m3and above. However, any concentration-dependence or particular sex-dependence was not observed. The maximum technically achievable concentration was 2729 mg/m3. The exposure to this exposure level caused lingering and pronounced irritant effects in the upper and lower respiratory tract. Mortality is considered to be linked to acute lung edema. Due to the absence of concentration-dependent changes in particle size, the LC50is greater than the maximum technically attainable concentration. Due to technical aspects as well as animal welfare considerations, the testing of CaTG at around 3000 mg/m3is considered to meet the criteria of limit-test of contemporary testing guidelines.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
1 896 mg/m³

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-Mar-2012 - 28-Aug-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 290 ± 7 g for the males and 228 ± 6 g for the females
- Water and food: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG400
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:
A single dose of 2000 mg/kg of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of PEG 400) and then applied to the clipped area of the skin.
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 389 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
A reduced body weight gain or a slight body weight loss was seen in 2/5 females between day 8 and day 15. The overall body weight gain of the other animals was similar to that of CIT historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Interpretation of results:
moderately toxic
Remarks:
Migrated information Because the test item in contact with purified water had a pH of 12. Criteria used for interpretation of results: expert judgment
Conclusions:
Under the experimental conditions, the dermal LD50 of CaTG is higher than 2000 mg/kg in rats.
Executive summary:

The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females).

The application was performed with the test item in its original form at the dose-level of 2000 mg/kg. PEG 400 was used to moisten the gauze pad and ensure a good contact with the skin.

The test site was then covered by a semi-occlusive dressing for 24 hours.

Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item.

All animals were subjected to necropsy.

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

A reduced body weight gain or a slight body weight loss was seen in 2/5 females between day 8 and day 15. The overall body weight gain of the other animals was similar to that of CIT historical control animals.

Skin reactions were noted in almost all animals between day 3 and day 14 at the latest.

No apparent abnormalities were observed at necropsy in any animal.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 389 mg/kg bw
Quality of whole database:
LD50 determined with CaTG (LD50 is >2000 mg/kg bw corresponding to > 1389 mg/kg bw a. i. thioglycolate)

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.


Justification for selection of acute toxicity – oral endpoint
LD50 determined with CaTG (LD50 = 352 mg/kg bw corresponding to 245 mg/kg bw a. i. thioglycolate)

Justification for selection of acute toxicity – inhalation endpoint
LC50 determined with CaTG (LC50 is >2729 mg/m³ bw corresponding to > 1896 mg/m³ bw 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.