Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
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:
One or two New Zealand Albino rabbits (m or f) in each dosing group were dosed with undiluted TS over 24 hrs. 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
Details on test material:
Lot/batch No.: XF 958

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Sex:
male/female
Details on test animals and environmental conditions:
Initial body weights: 2100 - 2200 g (m) and 1800 - 2200 g (f)

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No further data
Duration of exposure:
24 hrs
Doses:
1000, 2000, 3160, 5010 or 7940 mg/kg bw
No. of animals per sex per dose:
1000 mg/kg bw: 1 m
2000 mg/kg bw: 1 f
3160 mg/kg bw: 1 m
5010 mg/kg bw: 1 f
7940 mg/kg bw: 1 m / 1 f
Control animals:
not specified
Details on study design:
Survivors were sacrificed 14 days after dosing.
Statistics:
No data

Results and discussion

Preliminary study:
Slighty irritating according to Draize socre: not irritating.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
1000 mg/kg bw: 0/1 m
2000 mg/kg bw: 0/1 f
3160 mg/kg bw: 0/1 m
5010 mg/kg bw: 1/1 f
7940 mg/kg bw: 0/1 m and 1/1 f

Survival time: 2 - 4 days
Clinical signs:
reduced appetite and activity (4 - 7 days in survivors), increasing weakness, collapse and death.
Body weight:
No data
Gross pathology:
Decedents: Haemorrhagic areas of the lungs, liver hyperaemia, enlarged gall bladder and 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 dermal LD50 value for male and female rabbits was > 3160 mg/kg bw.
Executive summary:

In this older study one or two New Zealand Albino rabbits (m or f) in each dosing group were dosed with undiluted TS at doses of 1000, 2000, 3160, 5010 or 7940 mg/kg bw over 24 hrs. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically. The dermal LD50 value for male and female rabbits was given with > 3160 mg/kg bw. Toxic signs included reduced appetite and activity, increasing weakness, collapse and death. In decedents, haemorrhagic areas of the lungs, liver hyperaemia, enlarged gall bladder and GI tract inflammation were noted, while in survivors viscera appeared normal.

This is the lowest value, as the other study give a higher one (13700 mg/kg)