Registration Dossier
Registration Dossier
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EC number: 611-435-6 | CAS number: 56962-04-0
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-bromo-5-chlorophenol
- EC Number:
- 611-435-6
- Cas Number:
- 56962-04-0
- Molecular formula:
- C6H4BrClO
- IUPAC Name:
- 3-bromo-5-chlorophenol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- Breeder: LPT Laboratory of Pharmacology and Toxicology GmbH Löhndorf
Sex: Female
Number of animals: 1
Weight: 3.0 kg
Age: Approx. 21 months
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg/patch and animal (1000 mg test item were mixed with 0.5 ml purified water. 750 mg of this paste were applied per animal (500 mg test item/ animal)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 min and 24, 48, and 72 hours after patch removal
- Number of animals:
- 1
- Details on study design:
- A single patch was applied to one animal for 4 hours. Since the test item showed corrosive properties 60 minutes after patch removal, the test was immediately terminated. No further rabbits were tested.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: after 60 min
- Score:
- 2
- Reversibility:
- no data
- Remarks on result:
- other: No signs od systemic toxicity
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: after 60 minutes
- Score:
- 2
- Reversibility:
- no data
- Remarks on result:
- other: no signs of systemic toxicity
- Other effects:
- Brown discolouration and full thickness destruction of the test site.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- One rabbit exposed for 4 hours to 500 mg of the test substance under semi-occlusive condition revealed an erythema of grade 2 and an oedema of grade 2 observed after 60 minutes after patch removal. Thus, the study was immediately terminated.
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