Bordeaux mixture

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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: 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 and acclimatised prior to dosing. Body weight at study initiation was 186 to 319 grams.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Test material was applied on a surgical gauze patch (5 x 5 cm) moistened with distilled water to an area of intact shaven skin, approximately 25 cm2 in size (approximately 10% of the total body surface area), of each rat on Day 1. The patch was held in place with non-irritating occlusive tape wrapped around the trunk of the animal. After 24 hours, the dressings were removed and the skin wiped with dampened tissue to remove residual test substance.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

Five males and five females.

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: The only clinical sign recorded was a red nasal discharge in all females two and four hours after dosing.

Gross pathology:

No gross findings were recorded at necropsy.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of Bordeaux Mixture to the rat was greater than 2000 mg/kg bw for males and females.
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified.

Executive summary:

A GLP-compliant acute dermal toxicity study was conducted in accordance with EU method B.3 and OECD 402 without significant deviation. Bordeaux Mixture was used. Five male and five female Sprague-Dawley rats weighing 186 to 319 g were housed in groups of up to five by sex and acclimatised prior to dosing. A dose level of 2000 mg/kg bw was applied on a surgical gauze patch (5 x 5 cm) moistened with distilled water to an area of intact shaven skin, approximately 25 cm2 in size (approximately 10% of the total body surface area), of each rat on Day 1. The patch was held in place with non-irritating occlusive tape wrapped around the trunk of the animal. After 24 hours, the dressings were removed and the skin wiped with dampened tissue to remove residual test substance. Animals were observed for treatment-related clinical signs frequently on the day of administration and once daily for the 14 day post-dosing period. Animals were weighed prior to treatment and after 7 days (Day 8) and 14 days (Day 15). Decedents and animals surviving to 14 days were subject to gross necropsy.

There were no mortalities. The only clinical sign recorded was a red nasal discharge in all females two and four hours after dosing. All animals showed acceptable weight gain during the study. No gross findings were recorded at necropsy. The acute dermal LD50 of Bordeaux Mixture to the rat was greater than 2000 mg/kg bw for males and females. On this basis, Bordeaux Mixture is not classified.