Registration Dossier
Registration Dossier
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EC number: 248-697-2 | CAS number: 27858-32-8
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline line study from read-across substance without detailed documentation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Interspecies Comparisons of Skin Irritancy
- Author:
- Nixon G, Tyson C & Wertz W
- Year:
- 1 975
- Bibliographic source:
- Toxicology and Applied Pharmacology 31, 481-490
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Revised Federal Hazardous Substances Act (FHSA)
- Deviations:
- yes
- Remarks:
- For solid materials 0,25g of test material was mixed with 0,25ml water, rather than 0,5ml of test material with 0,5ml of water as called for in the procedure
- GLP compliance:
- no
Test material
- Reference substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- Molecular formula:
- C3H8O
- IUPAC Name:
- propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): isopropyl alcohol
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No details provided
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abrated skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Test substance was applied undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- at 4, 24 and 48 hours
- Number of animals:
- no data
- Details on study design:
- TEST SITE
- Area of exposure: 2 intact sites and 2 abrated sites per animal
- % coverage: not reported
- Type of wrap if used: patch (unspecified)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 4,24,48h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no irritation observed
- Irritation parameter:
- overall irritation score
- Remarks:
- abrated skin
- Basis:
- mean
- Time point:
- other: 4,24,48h
- Score:
- 0.8
- Max. score:
- 8
- Reversibility:
- no data
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- average of above scores
- Basis:
- mean
- Time point:
- other: 4,24,48h
- Score:
- 0.4
- Max. score:
- 8
- Reversibility:
- no data
- Irritation parameter:
- other: tissue destruction
- Basis:
- mean
- Time point:
- other: 4,24,48h
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no corrosion was observed in any (0) of the 6 sites tested
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The dermal irritation/corrosion potential of propan-2-ol was evaluated when applied to the skin of rabbits. The test substance was a non-irritant under conditions of this study.
- Executive summary:
This study was regarded reliable with restrictions since the study was performed according to Federal Hazardous Substance Act (FHSA)(Code for Federal Regulations, 1973). However, the publication do not present all details on study design and used methods.
By the publication, propan-2 -ol was determined to have negligible potential for skin irritancy. According to EU regulation No. 1272/2008 (CLP)
propan-2 -ol is not classified for skin irritation/corrosion.The data presented here is used as weight of evidence information in CSA as the target substance hydrolyses immediately (half-life < 3minutes), and thus, the intrinsic properties of titanium tetraisopropanolate are related to main organic degradation product (propan-2 -ol).
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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