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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Slight variations of humidity were noted beyond the norms (minimum 45% RH) with aminimum at 36.4% RH. This deviation is not considered to have affected the outcome of the study.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Slight variations of humidity were noted beyond the norms (minimum 45% RH) with aminimum at 36.4% RH. This deviation is not considered to have affected the outcome of the study.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Test material: Copper II Sulphate Pentahydrate,
Lot/Batch number: Batch number 844,
Specification: Not stated,
Description: Blue crystals,
Purity: 99.0 - 100.5%,
Stability: Reported to be stable under the conditions of the study.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Source: E.S.D. (Chatillon-sur-Chalaronne, France)
Adult male rabbits were about 3 months old and in a body weight range of 2 - 3 kg at initiation of treatment.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: One untreated intact skin site per animal
Amount / concentration applied:
The copper II sulphate pentahydrate was applied at 0.5 g prepared as a paste with 0.07 g of purified water per animal.
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 male
Details on study design:
TEST SITE: Dorsal area of the trunk. The dose site was prepared by clipping the skin free of hair ensuring no dermal abrasions occurred.
REMOVAL OF TEST SUBSTANCE: Washing with water 4 hours after application.
SCORING SYSTEM: Draize scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for 3 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
for 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mean values for cutaneous irritation were 0.22 for erythema and 0 for oedema over the 24 to 72 hour period.
The lesions observed at 72 hours had overtly recovered by day 7.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is considered non-irritating to the skin of rabbits in accordance with the guidelines.
Executive summary:

Materials and Methods

The test substance article, copper II sulphate pentahydrate, was evaluated for it's potential to produce primary dermal irritation after a single topical 4 -hour application to the skin of rabbits at dose of 0.5 g. The design was in accordance with OECD 404 (1981), EEC 92/69 - Annex V - Method B4 (1992).

Results and Discussion

Clinical: a weak irritation with points of burnt appearance was provoked in one animal.

Mean values for cutaneous irritation were 0.22 for erythema and 0 for oedema.

The lesions observed at 72 hours showed good reversibility at day 7.

Conclusion

The test substance is considered non-irritating to the skin of rabbits in accordance with the guidelines.