Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF 4200 (1985)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
Clinical signs observed included lethargy, prostrate posture, green coloured diarrhoea, voiding few faeces and moribundity.
Body weight:
Weight loss of 11 to 15% of the fasted body weight occurred in male and female rats dosed at all dose levels within 1 day following dosing. The majority of surviving rats gained weight during the second week of observation.
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

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
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