Reaction mass of cobalt and copper and iron

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: Already evaluated by the Competent Authorities for Biocides and Existing Substance Regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF 4200 (1985)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

copper sulphate pentahydrate

IUPAC Name:

copper sulphate pentahydrate

Details on test material:

Lot/Batch number: Batch number 844, S
pecification: Not stated,
Description: Blue crystals,
Purity: 99.0 - 100.5%,
Stability: Reported to be stable under the conditions of the study.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Iffa Credo, B.P. 0109 (L'Arbresle Cedex, France)
At test initiation:
Males were 5 to 7 weeks old in a body weight range of 226 -234 g.
Females were 5 to 7 weeks old in a body weight range of 216 - 217 g.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

Purified water

Details on dermal exposure:

Male and female rats were exposed at 2000 mg/kg by cutaneous application of the test material in a paste formulation to 10% of the body surface. Exposure was for 24 hours under a semi-occlusive bandage.
Vehicle: Purified water
Concentration in vehicle: 175.66%(w/v).

Duration of exposure:

24 hours

Doses:

2,000 mg/kg [concentration in vehicle 175.66% w/v]

No. of animals per sex per dose:

10 (5 male and 5 female)

Control animals:

no

Details on study design:

Duration of observation period : 14 days
Daily observations of mortality and clinical observations of cutaneous examinations were performed from day 2 to 15. All rats were necropsied on
day 15.

Statistics:

No details.

Results and discussion

Preliminary study:

No mortality or clinical signs were observed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: No behavioural or clinical signs were observed in any of the treated animals during the observation period.

Gross pathology:

No macroscopic findings were observed that were associated with treatment.

Other findings:

LD50 (male and female rats combined) >2,000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male and female rats combined) >2000 mg/kg

Executive summary:

Materials and Methods

Male and female rats were exposed at 2000 mg/kg by cutaneous application of the test material in a paste formulation to 10% of the body surface. Exposure was for 24 hours under a semi-occlusive bandage. Clinical signs were observed over 14 days post-dose and all animals were subjected to necropsy at day 15.

Results and Discussion

No mortality was observed.

No behavioural or clinical signs were observed in any of the treated animals during the observation period.

LD50 (male and female rats combined) >2000 mg/kg.

Conclusion

LD₅₀(male and female rats combined) >2,000 mg/kg.