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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
Study period:
Not specified
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:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice of both sexes were once treated by oral gavage and then observed for 10 days for time of death. 10 different batches of the test material were tested and 3 different doses were used: 6000, 12000 and 24000 mg/kg bw. Each dose was tested in 10 animals.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiamine hydrochloride
EC Number:
200-641-8
EC Name:
Thiamine hydrochloride
Cas Number:
67-03-8
Molecular formula:
C12H17N4OS.ClH.Cl
IUPAC Name:
thiamine hydrochloride

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
6000, 12000 and 24000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 10 days
- Animals were observed for time of death

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
13 347 mg/kg bw
Based on:
test mat.
95% CL:
>= 11 527 - <= 15 167
Sex:
male/female
Dose descriptor:
other: LD10
Effect level:
9 136 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
other: LD90
Effect level:
19 670 mg/kg bw
Based on:
test mat.
Mortality:
All deaths occurred within 24 hours after dosing.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU Criteria
Conclusions:
Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw.
Executive summary:

The acute oral toxicity of the test material to mice was investigated.

Mice of both sexes were once treated by oral gavage and then observed for 10 days for time of death. 10 different batches of the test material were tested and 3 different doses were used: 6000, 12000 and 24000 mg/kg bw. Each dose was tested in 10 animals. No further information on study design was available.

All deaths occurred within 24 hours after dosing. LD50 was calculated to be >10000 mg/kg bw. This was true for each batch tested.

Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw.

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