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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 March-16 April 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
rats; 6 females / dose group.
exposure under occlusion for 24 hrs; surface area 32 cm2.
2 concentrations of solution in water; 3 dose levels per concentration
dose levels as given below.
observation for 14 days
daily observations; necropsy.


GLP compliance:
no
Remarks:
did not exist at that time
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: 32 cm2
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at removal of the patch with warm water
- Time after start of exposure:24 h

TEST MATERIAL
- Concentration (if solution):1%-5% and 40%
- Constant volume or concentration used: no data
Duration of exposure:
24 h
Doses:
50 and 10 mg/kg (1% ts concentration) ,
200, 400 mg/kg (5% ts concentration)
200, 281, 400, 2000 mg/kg (40% ts concentration)
No. of animals per sex per dose:
6 females per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:observations daily, weighing weekly
- Necropsy of survivors performed: yes
Statistics:
not used

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
305 mg/kg bw
Based on:
test mat.
95% CL:
242 - 384
Mortality:
yes
Clinical signs:
yes, neuro behavioural effects, lacrimation, respiratory difficulties
Body weight:
normal
Gross pathology:
all dead animals showed macroscopic changes in lungs and bowels.
At 2000 mg/kg the animals showed discolouration of the application site

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
It is concluded that the LD50 depends on the concentration of the formulation; i.e the LD50 is lower at higher concentrations.
LD50 = 305 mg/kg at 40% ts concentration