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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:
1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study performed in 1966, probably no GLP, reasonably documented (2-page summary report), but not sufficient to comply with guideline. Probably only one male animal per dose. Necropsy / pathological evaluation omitted. Submitted to US Office of Toxic Substances under TSCA, 1982.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Individual male animals treated by gavage with a wide range of doses (8 animals, 670 - 25000 mg/kg bw). Time of death and symptoms recorded.
GLP compliance:
no
Test type:
other: Approximate LD50, 1 animal per dose
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Trimetyl orthoformate TMOF
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 98%
- Density: 0.97 g/mL
- Impurities (identity and concentrations): no data
- Used as received

Test animals

Species:
rat
Strain:
other: ChR-CD
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 15% (up to 2250 mg/kg bw), 40% (3400-5000 mg/kg bw), and 100% (7500-25000 mg/kg bw)
- Amount of vehicle (if gavage): Depending on dose
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED:
25 ml/kg bw (pure test substance)

Doses:
670, 2250, 3400, 5000, 7500, 11000, 17000, 25000 mg/kg body weight
No. of animals per sex per dose:
1 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no (at request of the sponsoring department)
- Other examinations performed: clinical signs, body weight
Statistics:
none

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
approximate LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Death at 5000 mg/kg bw occurred 1 day after application; no deaths below this dose.
Mortality:
Death of single animal exposed: within minutes at doses above 7500 mg/kg bw; after one day upon treatment with 5000 mg/kg bw; no deaths below this dose
Clinical signs:
Lethal doses: incoordiantion, cyanosis, loss of muscle tone, rapid respiration, prostration, unresponsiveness
Non-lethal doses: decreased muscle tone for two hours post-treatment
Body weight:
Weight loss on first day after treatment, followed by normal growth

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met