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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:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Mass mean diameters of particles were 3.23, 3.55 and 3.65 μm, respectively. Respirable particles (<4μm) were 62.5, 56.7 and 54.9%, respectively. No purity data were reported. Copper content of the test substance was 57.28% w/w.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
1.14, 1.79 and 2.77 mg/
No. of animals per sex per dose:
five males and five females in each group
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
ca. 2.83 mg/L air (nominal)
Based on:
test mat.
95% CL:
> 2.23 - < 7.22
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
> 2.77 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 4.74 mg/L air (nominal)
Based on:
test mat.
95% CL:
> 3.09 - < 384
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC0
Effect level:
ca. 1.14 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
Deaths occurred at 1.79 mg/L (1/5 females; 2/5 males) and 2.77 mg/L (2/5 males); these deaths occurred overnight following exposure. No deaths occurred at 1.14 mg/L.
Clinical signs:
other: Clinical signs of toxicity, such as increased respiration rate, noisy/laboured breathing, hunched posture and/or ataxia, occurred in some animals during, or shortly after, exposure at all dose levels. Clinical signs returned to normal during the second w
Gross pathology:
At necropsy, lung abnormalities (enlargement, with dark/pale patches) were observed in premature decedents and in some surviving animals.

Any other information on results incl. tables

It was noted that the 95% confidence limits were wide in this study; the reason for this is uncertain.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study is of relatively good quality and can be used in a read-across approach for the classification of copper powders, flakes.
Executive summary:

An acute inhalation toxicity study which fully conformed to Annex V and OECD Test Guidelines (B.2 and 403, respectively) was conducted with copper oxychloride by Wesson (2003 – unpublished). Groups of Sprague Dawley rats (five males and five females in each group) were exposed by the nose only to copper oxychloride aerosol (1.14, 1.79 and 2.77 mg/L) for four hours. Mass mean diameters of particles were 3.23, 3.55 and 3.65 μm, respectively. Respirable particles (<4μm) were 62.5, 56.7 and 54.9%, respectively. No purity data were reported. Copper content of the test substance was 57.28% w/w. Deaths occurred at 1.79 mg/L (1/5 females; 2/5 males) and 2.77 mg/L (2/5 males); these deaths occurred overnight following exposure. No deaths occurred at 1.14 mg/L. Clinical signs of toxicity, such as increased respiration rate, noisy/laboured breathing, hunched posture and/or ataxia, occurred in some animals during, or shortly after, exposure at all dose levels. Clinical signs returned to normal during the second week after exposure. At necropsy, lung abnormalities (enlargement, with dark/pale patches) were observed in premature decedents and in some surviving animals. The following LC50values (and 95% confidence limits) were reported for copper oxychloride in this study: 2.83 mg/L (2.23-7.22) for males; >2.77 mg/L for females; 4.74 mg/L (3.09-384) for males and females combined. It was noted that the 95% confidence limits were wide in this study; the reason for this is uncertain.