Reaction mass of cobalt and copper and iron

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Copper oxychloride

IUPAC Name:

Copper oxychloride

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 levels

Effect levels 1

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

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

> 2.77 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 3

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

Effect levels 4

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

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.