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 Authority for Biocides and Existing Substances Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/Batch number: 02-0084
Description: Brown/black powder
Purity: 97.7% cupric oxide
Stability: Stable at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
Source: Charles River (UK) Ltd, Margate, Kent, UK
Age/weight at study initiation: Test animals were at least 200 g and were approximately 8 weeks old.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
Concentration in vehicle: 200 mg/ml
Total volume applied: 10 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 animals (2 groups both dosed 2000 mg/kg bw)
Control animals:
no
Details on study design:
Clinical observations, mortality, bodyweights and necropsy.
Observations for death or toxicity were taken 0.5, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Individual bodyweights were
measured prior to dosing and seven and fourteen days after treatment. All animals were subjected to gross pathological examination after death.
Statistics:
LD50 was determined from mortality data and not by statistical analysis.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities among any of the treated animals at study termination.
Clinical signs:
There were no signs of systemic toxicity at any observation time point in any of the treated animals.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

There were no mortalities or signs of systemic toxicity among any of the animals treated with copper oxide at the test concentration of 2000 mg/kg b.w. An LD50of >2500 mg/kg b.w can be estimated using the flow chart in annex 2d of OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 of >2500 mg/kg b.w can be estimated using the flow chart in annex 2d of OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001).
Executive summary:

Materials and Methods

The study was performed to assess the acute oral toxicity of copper oxide following a single oral administration by gavage in the Sprague-Dawley rat. A group of three fasted male rats were treated with the test material at a dose level of 2000 mg/kg bw administered as a suspension in Arachis oil BP. This was followed by a further group of three fasted males treated with the same dose level.

 

The animals were observed for deaths or overt signs of toxicity at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The individual bodyweights were recorded prior to dosing, 7 and 14 days after treatment. At the end of the observation period, the animals were sacrificed and subject to gross pathological examination.

 

The study was conducted according to OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001). The study was also conducted according to GLP.

 

No deviations from the test guidelines, or deficiencies in the method were reported.

Results and Discussion

There were no mortalities or signs of systemic toxicity among any of the animals treated with copper oxide at the test concentration of 2000 mg/kg b.w. All animals showed expected gains in bodyweight over the study period and there were no abnormalities noted at necropsy.

 

An LD50of >2500 mg/kg b.w can be estimated using the flow chart in annex 2d ofOECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001).

 

The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 93/21/EEC.