Registration Dossier
Registration Dossier
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EC number: 201-178-4 | CAS number: 79-11-8
Acute Toxicity: dermal
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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Chloroacetic acid
- EC Number:
- 201-178-4
- EC Name:
- Chloroacetic acid
- Cas Number:
- 79-11-8
- Molecular formula:
- C2H3ClO2
- IUPAC Name:
- chloroacetic acid
- Details on test material:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system 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:
- other: yes, neuro behavioural effects, lacrimation, respiratory difficulties
- 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
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