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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:
other: Older study: meets scientific standards with acceptable restrictions (e.g. limited number of animals in study and partly limited documentation)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Study from 1976 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
Mixed groups of 5 male and female Sprague-Dawley strain albino rats were dosed with undiluted TS via gavage at 4 dose levels. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically.
GLP compliance:
no
Remarks:
Study from 1976 (GLP was not compulsory at the time the study was performed).
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Lot/batch No.: XF 958

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Initial body weights: 220 - 235 g (m) and 225 - 240 g (f)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
3160, 3980, 5010 or 6310 mg/kg bw
No. of animals per sex per dose:
mixed groups of 5 male and female rats
Control animals:
not specified
Details on study design:
Survivors were sacrificed 14 days after dosing.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 900 mg/kg bw
95% CL:
3 550 - 4 290
Mortality:
3160 mg/kg bw: 0/5
3980 mg/kg bw: 3/5
5010 mg/kg bw: 3/5
6310 mg/kg bw: 5/5

Survival time: 1 - 5 days, most deaths within 2 days.
Clinical signs:
reduced appetite and activity (1 - 3 days in survivors), increasing weakness, collapse and death.
Body weight:
No data
Gross pathology:
Decedents: Haemorrhagic areas of the lungs, liver discoloration and acute GI tract inflammation.
Survivors: viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value for male and female rats was 3900 mg/kg bw.
Executive summary:

In this older study mixed groups of 5 male and female Sprague-Dawley strain albino rats were dosed via gavage with undiluted TS at doses of 3160, 3980, 5010 or 6310 mg/kg bw. The oral LD50 value for male and female rats was given with 3900 mg/kg bw. Toxic signs included reduced appetite and activity, increasing weakness, collapse and death. In decedents, haemorrhagic areas of the lungs, liver discoloration and acute GI tract inflammation were noted, while in survivors viscera appeared normal.

As the other data indicated a LD50 higher than this one, it will be taken as the oral LD50 for mix DIPB