Diphosphoric acid, copper salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2011-06-28 to 2011-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

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:

Dicopper hydroxide phosphate

EC Number:

235-285-2

EC Name:

Dicopper hydroxide phosphate

Cas Number:

12158-74-6

Molecular formula:

Cu2HO5P

IUPAC Name:

copper(2+) hydroxide phosphate (2:1:1)

Specific details on test material used for the study:

- Name of test material (as cited in study report): dicopper hydroxide phosphate
- Batch number: 08004
- CAS number: 12158-74-6
- EC number: 235-285-2
- solid: particulate/powder

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Deutschland
- Age at study initiation: Guinea pigs were young adults at the start of the study.
- Weight at study initiation: 350 - 450 g
- Housing: Guinea-pigs were kept in separate cages.
- Diet (e.g. ad libitum): Commercial feeding mixture was fed ad libitum.
- Water (e.g. ad libitum): Water was supplemented with 1g/l vitamin C. Access was ad libitum.
- Acclimation period: The animals were acclimated and permanently controlled by veterinarians according to DIN ISO 10993-2.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: The fur was removed from the dorsal area of the trunk of the test animals 24 hours before the test.Test material was applied over an area which is approximately 10% of the total body surface.
- % coverage: 10%
- Type of wrap if used: Test substance was held in contact with the skin with gauze dressing and tape throughout a 24 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The animals recieved an effective dose of 2000 mg/kg bodyweight moistened with water to ensure good skin contact.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5 males and 5 females.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The test animals were observed frequently during the first day and then at least once each day. The weighing of the test animals was carried out shortly before the test substance was applied and weekly thereafter.
- Necropsy of survivors performed: yes - a necropsy of all animals was carried out after 14 days.
- Other examinations performed:body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No test animals exhibited adverse physical symptoms or signs of toxicity after the application of the test material over the observation period of 14 days.

Body weight:

See tables 1 and 2.

Gross pathology:

A through gross pathological examination was performed by a pathologist. No abnormalities were noted in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 was determined to be > 2000 mg/kg bw.

Executive summary:

The test material did not induce toxic reactions in any of the test animals after dermal application and within an observation period of 14 days.

This study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement (Regulation (EC) No. 1907/2006; REACH) as a key study for this endpoint. In addition, this study is considered to be acceptable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).