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Toxicological information

Acute Toxicity: inhalation

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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

Constituent 1
Chemical structure
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.