Bordeaux mixture

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:

other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate

EC Number:

910-853-9

Cas Number:

8011-63-0

Molecular formula:

Ca3Cu4H6O22S4.nH2O where n = 1 to 6

IUPAC Name:

calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate

Details on test material:

- Name of test material (as cited in study report): Bordeaux Mixture
- Purity: 47% as copper hydroxysulphates
- Lot/batch No.: 27/7/00

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were housed individually and acclimatised prior to exposure.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Test atmospheres were generated with a modified Wright dust generator. The gravimetric test concentrations were determined by dividing the total weight of the test substance collected on a glass fibre filter positioned in the breathing zone of the animals by the volume of air sampled. The nominal test concentration was calculated by dividing the total weight of the test substance used by the total volume of air (average airflow multiplied by total time) passing through the chamber during exposure. The MMAD and the particle size distribution were calculated from two samples taken during exposure from the breathing zone of the animals with an Andersen cascade impactor. Chamber environmental conditions were monitored during the exposure.

Duration of exposure:

4 h

Concentrations:

Gravimetric concentrations of 1.05 mg/L (five males), 2.02 mg/L (five males and five females) and 3.08 mg/L (five males, maximum practical concentration).

No. of animals per sex per dose:

See Concentrations.

Control animals:

no

Details on study design:

Animals were observed for mortality and reaction to treatment at least every 30 minutes during exposure (1.05 and 2.02 mg/L treatments) or for the first hour of exposure (3.08 mg/L treatment) on Day 1 until accumulation of the test substance on the walls of the exposure chamber prevented this. After exposure, animals were observed at least once daily for 14 days. Body weights were recorded prior to exposure and after 7 days (Day 8), and 14 days (Day 15) or at death. Gross pathological examinations were performed on decedents and animals surviving for 14 days.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

1.97 mg/L air

Based on:

test mat.

95% CL:

1.63 - 2.47

Exp. duration:

4 h

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

> 2.02 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

There were no mortalities at 1.05 mg/L. At 2.02 mg/L, three males died but there were no female mortalities. At 3.08 mg/L, all males died. All deaths occurred on the day of exposure or within one day after exposure.

Clinical signs:

other: Clinical symptoms during exposure included ocular and nasal discharge, irregular breathing, dyspnoea, hunched posture and hypoactivity. After exposure, similar signs were recorded together with facial staining and/or reduced faecal volume. Surviving ani

Body weight:

Two females treated at 2.02 mg/L lost weight in the first week after treatment but gained weight in the second week. Other surviving animals gained weight during the study.

Gross pathology:

At necropsy, the animals which died during the study showed rigor mortis, oedema of the lungs, discoloration of the liver, discoloration of the lungs and mucous filled trachea. Surviving animals showed no gross abnormalities.

Other findings:

None.

Any other information on results incl. tables

Table 2. Summary of mortalities following inhalation administration

Gravimetric concentration (mg/L)	Males		Females
	Mortality	Time of death	Mortality	Time of death
1.05	0/5	-	-	-
2.02	3/5	Day 1 (2), Day 2	0/5	-
3.08	5/5	Day 1 (4), Day 2	-	-
Figures in parenthesis are the number which died on the day specified if more than one.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 (4 hour) of Bordeaux Mixture to the rat was 1.97 mg/L for males (with 95% confidence limits of 1.63 to 2.47 mg/L) and greater than 2.02 mg/L for females.
DSD Classification: Harmful (Xn). R20, Harmful by inhalation.
CLP Classification: Acute Tox. 4, H332: Harmful if inhaled.

Executive summary:

A GLP-compliant acute inhalation toxicity test was conducted in accordance with OECD Guideline 403 and US EPA OPPTS 870.1300 without significant deviation.  Test atmospheres of Bordeaux Mixture were generated with a modified Wright dust generator. Male and female Sprague-Dawley rats were housed individually and acclimatised prior to exposure. Groups of animals were exposed to an aerosol atmosphere of the test substance at gravimetric concentrations of 1.05 (five males), 2.02 mg/L (five males and five females) and 3.08 mg/L (five males, maximum practical concentration) for four hours using a whole body exposure system. The gravimetric test concentrations were determined by dividing the total weight of the test substance collected on a glass fibre filter positioned in the breathing zone of the animals by the volume of air sampled. The nominal test concentration was calculated by dividing the total weight of the test substance used by the total volume of air (average airflow multiplied by total time) passing through the chamber during exposure. The MMAD and the particle size distribution were calculated from two samples taken during exposure from the breathing zone of the animals with an Andersen cascade impactor. Chamber environmental conditions were monitored during the exposure. Animals were observed for mortality and reaction to treatment at least every 30 minutes during exposure (1.05 and 2.02 mg/L treatments) or for the first hour of exposure (3.08 mg/L treatment) on Day 1 until accumulation of the test substance on the walls of the exposure chamber prevented this. After exposure, animals were observed at least once daily for 14 days. Body weights were recorded prior to exposure and after 7 days (Day 8), and 14 days (Day 15) or at death. Gross pathological examinations were performed on decedents and animals surviving for 14 days.

There were no mortalities at 1.05 mg/L. At 2.02 mg/L, three males died but there were no female mortalities. At 3.08 mg/L, all males died. All deaths occurred on the day of exposure or within one day after exposure. Clinical symptoms during exposure included ocular and nasal discharge, irregular breathing, dyspnoea, hunched posture and hypoactivity. After exposure, similar signs were recorded together with facial staining and/or reduced faecal volume. Surviving animals recovered by Day 5. Two females treated at 2.02 mg/L lost weight in the first week after treatment but gained weight in the second week. Other surviving animals gained weight during the study. At necropsy, the animals which died during the study showed rigor mortis, oedema of the lungs, discoloration of the liver, discoloration of the lungs and mucous filled trachea. Surviving animals showed no gross abnormalities. On this basis Bordeaux Mixture is classified as Acute Tox. 4, H332: Harmful if inhaled.