Registration Dossier
Registration Dossier
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EC number: 223-829-1 | CAS number: 4090-51-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Standard protocol with some deficiencies in data reporting
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Skin irritation test according to Draize
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide
- EC Number:
- 223-829-1
- EC Name:
- 2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide
- Cas Number:
- 4090-51-1
- Molecular formula:
- C10H20O5P2S2
- IUPAC Name:
- 2,2'-oxybis(5,5-dimethyl-1,3,2-dioxaphosphinane) 2,2'-disulfide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- no details
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0,5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- Exposure period 24 h in this study, compared to 4 h in OECD guideline 404
Use of impervious wrap
SCORING SYSTEM:
Evaluation of results according to ETAD score system: Values for erythema and edema (maximal score: 4 each) for intact and abraded skin at 24 and 72 h are added and divided by 4 to give the primary irritation score:
0 - 0.5: non irritant
0.6 - 3.0: slightly irritant
3.1 - 5.0: moderately irritant
5.1 - 8.0: severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals were treated on abraded skin
- Time point:
- other: 24h and 72h
- Score:
- 0.166
- Max. score:
- 1
- Reversibility:
- other: Edema were observed in 6 animals on abraded skin at 72 h time point. No longer observation period described.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals were treated on abraded skin
- Time point:
- other: 24h and 74h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No erythema observed on abraded skin at any time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals were treated on intact skin
- Time point:
- other: 24h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No edema observed in intact skin at any time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals were treated: intact skin
- Time point:
- other: 14 h and 72 h after treatment
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No erythema observed on intact skin at any time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed on intact skin
- Remarks on result:
- other: Based on the evaluation scheme of guideline OECD 404, the effects on intact skin indicate an irritation score of 0 (based on restricted observation period at 24 and 72 h only)
- Irritation parameter:
- overall irritation score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- other: Edema of grade 1 observed in all animals after 72 h on abraded skin. Reversibility not described as the observation period ended at 72 hours.
- Remarks on result:
- other: ETAD score
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance was not irritating to skin
- Executive summary:
The test substance was applied to the skin of 6 albino rabbits for 24 h under an occlusive wrap. Skin reaction were evaluated at the end of exposure (time point 24 h) and 48 h thereafter (time point 72 h) according to the ETAD classification system. No skin irritation was observed in this study.
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