Registration Dossier
Registration Dossier
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EC number: 236-671-3 | CAS number: 13463-41-7
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:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pyrithione zinc
- EC Number:
- 236-671-3
- EC Name:
- Pyrithione zinc
- Cas Number:
- 13463-41-7
- Molecular formula:
- C10H8N2O2S2Zn
- IUPAC Name:
- Bis [1-hydroxy-2(1H)-pyridinethionato-O,S](T-4)-zinc
- Details on test material:
- Purity: 97.9%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Charles River Germany
Sex: Female
Age at study initiation: 1.7-1.8kg
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- Examination: 60min, 24, 48, 72hour
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: throughout study
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: thoughtout study
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: throughout study
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Irritant / corrosive response data:
- All areas treated with the test substance and all control areas were normal at each observation time.
Any other information on results incl. tables
Table 1. Table for skin irritation study |
|||
score (average animals investigated) |
time |
Erythema |
Edema |
average score |
60 min |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
other times |
State time |
n.a. |
n.a. |
average score |
24h, 48h, 72h |
0.0 |
0.0 |
reversibility: * |
n.a. |
n.a. |
|
average time for reversibility |
n.a. |
n.a. |
|
* c : completely reversible |
|||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- All areas treated with the test substance and all control areas were normal at each observation time. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.
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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