Registration Dossier
Registration Dossier
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EC number: 616-328-8 | CAS number: 76359-37-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Analogue substance tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Analogue substance (refer to IUCLID chapter 13)
- IUPAC Name:
- Analogue substance (refer to IUCLID chapter 13)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: polyethylene glycol and saline (7:3 parts)
- Controls:
- no
- Amount / concentration applied:
- On test day 1, 0.5 g of the test article was applied to the intact skin of the shaved area and covered with an occlusive dressing.
- Duration of treatment / exposure:
- Four hours after the application, the occlusive dressing was removed and the skin was flushed with water.
- Observation period:
- The skin reaction was assessed then and at 1-, 24-, 48 and 72 hours intervals after removal of the dressing, gauze patch and test article.
- Number of animals:
- 1 male, 2 females
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Other effects:
- In the area of application a slight blue discoloration of the skin was observed.
Any other information on results incl. tables
No corrosion effect had occurred on the skin at each measuring interval.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test on the primary skin irritation was carried out with the analogue substance. As a result of the test, the analogue substance did not show a corrosive or irritating effect to the skin. Due to the structural similarity of the analogue substance and the substance subject of registration, the substance subject of registration is expected to show a comparable behaviour.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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