Registration Dossier
Registration Dossier
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EC number: 233-866-5 | CAS number: 10402-16-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF 4200 (1985)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Copper sulphate pentahydrate
- IUPAC Name:
- Copper sulphate pentahydrate
- Details on test material:
- Lot/Batch number: Batch number 844,
Specification: Not stated,
Description: Blue crystals, Purity: 99.0 - 100.5%,
Stability: Reported to be stable under the conditions of the study
Constituent 1
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)
Male rats were 5 to 7 weeks old in body weight range of 130 - 230 g.
Female rats were 5 to 7 weeks old in body weight range of 120 - 180 g at initiation of treatment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Purified water
- Details on oral exposure:
- Dose: 447, 562, 708 and 893 mg/kg.
Concentration in vehicle: 2.235, 2.810, 3.540 and 4.465%.
Individual doses were adjusted to take account of animal's fasted bodyweight to achieve the dose levels. Additionally, the doses were adjusted for purity. The rats were fasted overnight (approxomately 15 to 20 hours) prior to dosing. - Doses:
- 447, 562, 708 and 893 mg/kg.
- No. of animals per sex per dose:
- 10 (5 male and 5 female)
- Control animals:
- yes
- Details on study design:
- Post exposure period: 14 days
Daily observations of mortality, clinical observations of toxicity or behavioural change and body weights. All rats found dead or sacrificed were necropsied. - Statistics:
- LD50s calculated using Bliss and Litchfield & Wilcoxon's methods.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 482 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 403 - < 575
- Remarks on result:
- other: by Bliss method
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 481 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 400 - < 580
- Remarks on result:
- other: by Litchfield & Wilcoxon's method
- Mortality:
- Motalities at the 447, 562, 708 and 893 mg/kg dose levels were 40, 70, 90 and 100% respectively. Mortalities occurred within the first four hours after dosing.
- Clinical signs:
- other: Clinical signs observed included lethargy, prostrate posture, green coloured diarrhoea, voiding few faeces and moribundity.
- Gross pathology:
- Stomach distention with green fluid occurred in one female dosed at 562 and one male dosed at 708 mg/kg and one female at 447 mg/kg (this female also had liver discolouration)
The intestine of 2 males at 893 mg/kg and one male at 447 mg/kg were slightly congested.
There were no other macroscopically detectable abnormalities.
Applicant's summary and conclusion
- Conclusions:
- LD50 (male and female rats combined):
482 mg/kg (95% confidence limits of 403 to 575 mg/kg) by Bliss method.
481 mg/kg (95% confidence limits of 400 to 580 mg/kg) by Litchfield & Wilcoxon's method - Executive summary:
Materials and Methods
Fasted male and female rats were dosed at 447, 562, 708 and 893 mg/kg by oral gavage administration of the test material, copper II pentahydrate solution. Clinical signs and body weights were observed over 14 days post-dose and all animals were subjected to a necropsy.
Results
Mortalities at the 447, 562, 708 and 892 mg/kg treatment groups were 40, 70, 90 and 100% respectively.
Clinical signs observed included lethargy, prostrate posture, green coloured diarrhoea, voiding few faeces and moribundity.
All decedents died within 1 - 24 hours after dosing.
Conclusion
LD50(male and female rats combined):
482 mg/kg (95% confidence limits of 403 to 575 mg/kg) by Bliss method
481 mg/kg (95% confidence limits of 400 to 580 mg/kg) by Litchfield & Wilcoxon’s method
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