Registration Dossier
Registration Dossier
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EC number: 231-847-6 | CAS number: 7758-98-7
Skin irritation / corrosion
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:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- 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
- 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. QA statement)
Test material
- Reference substance name:
- Copper sulphate
- EC Number:
- 231-847-6
- EC Name:
- Copper sulphate
- Cas Number:
- 7758-98-7
- Molecular formula:
- CuSO4
- IUPAC Name:
- copper(2+) sulfate
- Reference substance name:
- 231847-6
- IUPAC Name:
- 231847-6
- 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.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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