Registration Dossier
Registration Dossier
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EC number: 700-227-1 | CAS number: 40722-73-4
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- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- 81485-04-3
- EC Number:
- 617-238-1
- Cas Number:
- 81485-04-3
- IUPAC Name:
- 81485-04-3
- Reference substance name:
- 2-Chloro-3-(2-chloro-ethyl)-[1,3,2]oxazaphosphinane 2-oxide
- IUPAC Name:
- 2-Chloro-3-(2-chloro-ethyl)-[1,3,2]oxazaphosphinane 2-oxide
- Details on test material:
- Batch number 110904 4th Dec 1990
Purity >99%
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5gm - moistened with 0.14 ml demineralised water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1,24, and 72 hours after removal of the patches - then once daily up to 8 days after application.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3.8
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1.75
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- No systemic effects observed
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Isophamchloride was classified as moderately irritant on the skin of the rabbit
- Executive summary:
Isophamchloride was investigated for primary irritant/corrosive effects at the skin of rabbits. The test substance (0.5 g) was given to the dorsal skin area of three animals each (4 hours, occlusive patch)
Observed skin reactions
Erythema - Well defined or moderate to severe erythema
Edema - Slight to moderate edema
Additional skin reactions - Formation of skin scales
The findings were recorded up to day 7 after application.
The primary irritation index was 3.8.
Isophamchloride was classified as moderately irritant on the skin of the rabbit.
Systemic toxic effects could not be detected,
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