Registration Dossier
Registration Dossier
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EC number: 231-847-6 | CAS number: 7758-98-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Already evaluated by the Competent Authorities for Biocides and Existing Substance Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Copper sulphate
- EC Number:
- 231-847-6
- EC Name:
- Copper sulphate
- Cas Number:
- 7758-98-7
- Molecular formula:
- CuSO4
- IUPAC Name:
- copper(2+) sulfate
- Reference substance name:
- 2310847-6
- IUPAC Name:
- 2310847-6
- Details on test material:
- Lot/Batch number: Batch number 844, S
pecification: Not stated,
Description: Blue crystals,
Purity: 99.0 - 100.5%,
Stability: Reported to be stable under the conditions of the study.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Iffa Credo, B.P. 0109 (L'Arbresle Cedex, France)
At test initiation:
Males were 5 to 7 weeks old in a body weight range of 226 -234 g.
Females were 5 to 7 weeks old in a body weight range of 216 - 217 g.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- Purified water
- Details on dermal exposure:
- Male and female rats were exposed at 2000 mg/kg by cutaneous application of the test material in a paste formulation to 10% of the body surface. Exposure was for 24 hours under a semi-occlusive bandage.
Vehicle: Purified water
Concentration in vehicle: 175.66%(w/v). - Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg [concentration in vehicle 175.66% w/v]
- No. of animals per sex per dose:
- 10 (5 male and 5 female)
- Control animals:
- no
- Details on study design:
- Duration of observation period : 14 days
Daily observations of mortality and clinical observations of cutaneous examinations were performed from day 2 to 15. All rats were necropsied on
day 15. - Statistics:
- No details.
Results and discussion
- Preliminary study:
- No mortality or clinical signs were observed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No behavioural or clinical signs were observed in any of the treated animals during the observation period.
- Gross pathology:
- No macroscopic findings were observed that were associated with treatment.
- Other findings:
- LD50 (male and female rats combined) >2,000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Under the conditions of the limit test. Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (male and female rats combined) >2000 mg/kg
- Executive summary:
Materials and Methods
Male and female rats were exposed at 2000 mg/kg by cutaneous application of the test material in a paste formulation to 10% of the body surface. Exposure was for 24 hours under a semi-occlusive bandage. Clinical signs were observed over 14 days post-dose and all animals were subjected to necropsy at day 15.
Results and Discussion
No mortality was observed.
No behavioural or clinical signs were observed in any of the treated animals during the observation period.
LD50 (male and female rats combined) >2000 mg/kg.
Conclusion
LD50(male and female rats combined) >2,000 mg/kg.
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