Bordeaux mixture

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral 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 test date: Not stated
- Lot/batch No.: 3/0371

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were housed in groups of up to five by sex, acclimatised, and fasted overnight prior to dosing. Food was returned four hours after dosing. Body weight at study initiation was 128 to 249 grams.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg on day 1.

Doses:

Dose levels (based on a range-finding study) were 1600, 2000, 2400 and 2800 mg/kg bw.

No. of animals per sex per dose:

Groups of five males and five females.

Control animals:

no

Details on study design:

Animals were observed frequently on the day of dosing and then once daily for the 14 day post-dosing period. Animals were weighed prior to administration and after 7 days (on Day 8) and after 14 days (on Day 15) or at death. Decedents and animals surviving to 14 days were subject to gross necropsy.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 187 mg/kg bw

Based on:

test mat.

95% CL:

1 843 - 2 499

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2 433 mg/kg bw

Based on:

test mat.

95% CL:

2 052 - 3 344

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 302 mg/kg bw

Based on:

test mat.

95% CL:

2 098 - 2 516

Mortality:

There were no mortalities at 1600 mg/kg bw. At higher doses, the frequency of mortality increased and all males and four females died (or were killed in extremis) following 2800 mg/kg bw. The deaths occurred between Day 2 and Day 13. A summary of mortalities is shown in Table 1.

Clinical signs:

other: There was a variety of clinical signs recorded including piloerection, soiled coat, reduced activity, red nasal and ocular discharge, ataxia, pale and hunched appearance, swollen abdomen, tail lesions, subdued behaviour, diarrhoea, dark eyes, laboured bre

Gross pathology:

No gross findings were recorded in surviving animals except for dark red foci on the lungs in one male dosed at 1600 mg/kg bw. Findings in animals that died during the study included reddening of the glandular mucosa of the stomach, liquid retention in the stomach and intestines, green coloured kidneys, small seminal vesicles and light coloured foci on the caecum.

Other findings:

None.

Any other information on results incl. tables

Table 1. Summary of Mortalities

Dose (mg/kg bw)	Males		Females
	Mortality	Time of death	Mortality	Time of death
1600	0/5	-	0/5	-
2000	1/5	Day 2	1/5	Day 3
2400	4/5	Day 9 (2); Day 10; Day 13	2/5	Day 4; Day 7
2800	5/5	Day 3; Day 5; Day 6; Day 9 (2)	4/5	Day 5 (2); Day 6 (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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of Bordeaux Mixture to the rat was 2187 mg/kg bw for males, 2433 mg/kg bw for females and 2302 mg/kg bw for the sexes combined.
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified.

Executive summary:

A GLP-compliant acute oral toxicity study was conducted in accordance with the requirements of EU Guideline B.1 and OECD 401. Bordeaux Mixture was administered as a solution in 0.5% carboxymethyl cellulose. Groups of five male and five female Sprague-Dawley rats weighing 128 to 249 g were used. The rats were housed in groups of up to five by sex, acclimatised, and fasted overnight prior to dosing. Food was returned four hours after dosing. Dose levels (based on a range-finding study) of 1600, 2000, 2400 and 2800 mg/kg bw were administered by single oral administration by gavage in 10 mL/kg on Day 1. Animals were observed frequently on the day of dosing and then once daily for the 14‑day post-dosing period. Animals were weighed prior to administration and after 7 days (on Day 8) and after 14 days (on Day 15) or at death. Decedents and animals surviving to 14 days were subject to gross necropsy.

There were no mortalities at 1600 mg/kg bw. At higher doses, the frequency of mortality increased and all males and four females died (or were killed in extremis) following 2800 mg/kg bw. The deaths occurred between Day 2 and Day 13. There was a variety of clinical signs recorded including piloerection, soiled coat, reduced activity, red nasal and ocular discharge, ataxia, pale and hunched appearance, swollen abdomen, tail lesions, subdued behaviour, diarrhoea, dark eyes, laboured breathing, prostration, hypothermia, alopecia and emaciation. Most symptoms occurred between Day 2 and 8 though some effects persisted up to Day 15.  Surviving animals showed acceptable weight gain during the study. No gross findings were recorded in surviving animals except for dark red foci on the lungs in one male dosed at 1600 mg/kg bw. Findings in animals that died during the study included reddening of the glandular mucosa of the stomach, liquid retention in the stomach and intestines, green coloured kidneys, small seminal vesicles and light coloured foci on the caecum.

The acute oral LD50 (calculated by probit analysis) of Bordeaux Mixture to the rat was 2187 mg/kg bw for males (with 95% confidence limits of 1843 to 2499 mg/kg bw), 2433 mg/kg bw for females (with 95% confidence limits of 2052 to 3344 mg/kg bw) and 2302 mg/kg bw for the sexes combined (with 95% confidence limits of 2098 to 2516 mg/kg bw). On this basis, Bordeaux Mixture is not classified.