Registration Dossier
Registration Dossier
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EC number: 413-370-7 | CAS number: 17351-75-6 RAPICURE CHVE
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Minor deviations to OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- abraded and non abraded skin
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,4-bis[(vinyloxy)methyl]cyclohexane
- EC Number:
- 413-370-7
- EC Name:
- 1,4-bis[(vinyloxy)methyl]cyclohexane
- Cas Number:
- 17351-75-6
- Molecular formula:
- C12 H20 O2
- IUPAC Name:
- (1r,4r)-1,4-bis[(ethenyloxy)methyl]cyclohexane; (1s,4s)-1,4-bis[(ethenyloxy)methyl]cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): divinyl ether of 1,4-cyclohexane, dimethanol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CAMM Resarch (Wayne, NJ, USA)
- Weight at study initiation: ca. 2 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18,3 -23,9 °C (65 - 75 °F)
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: abraded and non-abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2,5 cm² (flank)
- Type of wrap if used: J&J gauze sponge, Webril pad, J&J dermicel hypo-allergenic cloth tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h
SCORING SYSTEM:Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: (non-Abraded)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: (non-abraded)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: (non-abraded)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: (non abraded)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 -72 h
- Score:
- 3.2
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- Skin was discribed as bleached in 2/6 animal 24 h post application.
Skin was discribed as dry in 3/6 animal 72 h post application.
1/6 animals had a fisur 72 h post aplication.
Except edema after 72 h (score 2.7) results on abraded skin were in the same range as those on non-abraded skin.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Executive summary:
The study is reliable with restrictions due to some deviations to the OECD Guideline. The test substance was applied on abraded and non-abraded skin of 6 rabbits. Edema (max.3 of 4 ) and Erythem (max. 4 of 4) was observed. Primary dermal irritation index was 3.2.
The study was terminated 72 h post application and effects were not fully reversible within this time.
Conclusion
1,4 -bis[(vinyloxy)methyl]cyclohexane is irritating to the skin.
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