Dicopper oxide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

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:

1973

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

US Federal Hazardous Substances Labeling Act Regulations

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dicopper oxide

EC Number:

215-270-7

EC Name:

Dicopper oxide

Cas Number:

1317-39-1

Molecular formula:

Cu2O

IUPAC Name:

copper (I) oxide

Details on test material:

Purity: No data

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

At the start of the study animals weighed 241 to 271 g. No information was provided on the age of the animals.

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

other: none

Details on inhalation exposure:

The test material was used as supplied.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Concentrations:

200 mg/l (nominal)

No. of animals per sex per dose:

One group of 10 males

Control animals:

no

Details on study design:

The animals were weighed before exposure and at the end of the two week observation period. Gross observations were made relative to their well-being and at autopsy.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 200 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

There were no deaths in this study.

Clinical signs:

other: Clinical signs were not reported.

Body weight:

All test organisms gained weight over the course of the 14 day observation period.

Gross pathology:

Upon autopsy, survivors showed no abnormalities of organs of the thorax and abdomen.

Other findings:

The results are summarised in Table 1.

Any other information on results incl. tables

Table 1.         Acute inhalation toxicity study - summary of findings
Dose [mg/l]	Number of dead / number of investigated	Time of death (range)	Observations
200 (males)	0/10	-	Clinical signs were not reported. There were no gross necropsy findings.
LC50(1 h) in the male at > 200 mg/l (nominal concentration)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In the study, the acute inhalation LC50 (1 h) in the male rat was found to be greater than 200 mg/l (nominal concentration). However this study showed major methodological and reporting deficiencies and the results are therefore considered to be unreliable.

Executive summary:

Materials and Methods:

This study was not conducted according to GLP and showed major methodological and reporting deficiencies.  Deviations from OECD Test Guideline 403 include:

Test material concentrations in the test breathing zone, and particle size distribution were not measured,

The exposure period was only 1 h (compared to 4 hrs recommended in the test guideline),

There is no justification for the use of only male animals,

The following information was not reported:

- The purity of the test substance,

- Strain, age and source of test animals,

- Experimental test and housing conditions of the animals.

The following brief description of the test design was given in the study report:

Ten male rats were placed in an enclosed chamber. The test sample was sprayed into the chamber to yield a concentration of 200 mg/ml in the atmosphere. This concentration was maintained for a period of one hour. Following exposure the animals were held for a period of two weeks. The animals were weighed before exposure and at the end of the two weeks. Gross observations were made relative to well-being and at autopsy.

Results and Discussion:

There were no deaths. Clinical signs were not reported.

Upon autopsy, survivors showed no abnormalities of organs of thorax and abdomen.