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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Protection against Acetaldehyde Toxicity in the Rat by L-Cysteine, Thiamin and L-2-Methylthiazolidine-4-carboxylic Acid
Author:
Sprince, H. et al.
Year:
1974
Bibliographic source:
Agents Actions. 4(2):125-130

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The oral LD50 values were obtained by the Litchfield-Wilcoxon method after oral intubation of the test substance in 15 male CFE albino rats using 8 dose levels ranging from 4 up to 16 mM/kg bw.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CFE albino rat
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Carworth Farms
- Age at study initiation: 90 ± 5 days
- Weight at study initiation: 365 ± 20 g
- Fasting period before study: Animals were fasted overnight prior to administration.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
VEHICLE
- Amount of vehicle: 1 - 2.5 mL (total)
Doses:
4, 6, 8, 10, 11, 12,14 and 16 mM/kg bw
No. of animals per sex per dose:
15
Control animals:
yes
Details on study design:
The oral LD50 values were obtained by the Litchfield-Wilcoxon method.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 710 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 3710 mg/kg bw, calculated from 11.0 mM/kg bw (according to Sprince et al., 1974)
Mortality:
Death occurred within 15 - 45 minutes after intubation from respiratory failure.
Clinical signs:
Marked tremors developed within 5 - 10 minutes, persisting for another 5 - 10 minutes and were followed by a characteristic jumping behavior for about 1 - 3 minutes. Soon thereafter, the animals became limp.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified