Registration Dossier
Registration Dossier
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EC number: 266-019-3 | CAS number: 65996-85-2 The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no data about purity of test substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Principles of method if other than guideline:
- In vitro skin irritation examined by HUMAN SKIN MODEL TEST according to the method B.46 ANNEX III (Regulation REACH 1907/2006)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Details on test material:
- BATCH: N2B
DATE OF PRODUCTION: 04.11.2008
no further details
Constituent 1
Test animals
- Species:
- other: in vitro
Test system
- Type of coverage:
- other: in vitro
- Vehicle:
- water
- Controls:
- other: positive (5 % sodium dodecyl sulfate) and negative (physiol. saline) controls
- Amount / concentration applied:
- 25 mg per tissue insert solved in 25 µL water
- Duration of treatment / exposure:
- 1 h
- Observation period:
- 42 h postincubation plus 3 h MTT medium
- Number of animals:
- tested on three tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: discrimination between irritant and non-irritant effects in vitro
- Remarks on result:
- other:
- Remarks:
- Remarks: irritant. (migrated information)
Any other information on results incl. tables
Optical density (no data about units): 2.43 in negative control, 0.21 in positive control and 0.21 after treatment with the test substance.
Cell viability: 100% in negative control, 8.8 in positive control and 8.6 after treatment with the test substance.
Viability <50% after 1 h exposure corresponds to irritant properties.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Skin irritant properties have been shown in In vitro skin irritation examined by HUMAN SKIN MODEL TEST according to the method B.46 ANNEX III (Regulation REACH 1907/2006). However, no discrimination between corrosive and irritant properties is possible with this test system.
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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