Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-400-9 | CAS number: 13351-61-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-08-31 to 1981-10-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to OECD guideline 406, no GLP study, unclear if highest non irritating dose was used. Only 20 % mixture in peanut oil was tested.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchtstierzucht, Hagemann GmbH & Co. KG, Hamelner Straße 3, 4923 Exertal
- Weight at study initiation: 250 g (mean weight)
- Housing: Macrolon cages III, height: 14 cm, width: 25 cm, length: 42 cm
- Diet: Ssniff-G, pellets
- Water: ad libitum, tap water
- Acclimation period: ca 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12, light from 7 am to 7 pm - Route:
- epicutaneous, semiocclusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.5 mL
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.5 mL
- No. of animals per dose:
- 20 females test group
10 females control group - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test group: 20 test animals were treated once a week for the duration time of 3 weeks on the clipped left side with the test substance.
- Control group: 10 animals were treated only with the vehicle in a similar manner to that used for the treated group.
- Site: Clipped left side
- Frequency of applications: every week
- Duration: 3 weeks
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.
B. CHALLENGE EXPOSURE (14 days after the last induction exposure)
- No. of exposures: 3
- Exposure period: 6 hours
- Test group/ Control group: Both groups are treated with the test substance on the right side of the animals.
- Site: Right side
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.
- Evaluation (hr after challenge): Right side was depilated after 24 hours, evaluation after 2 hours, 24 and 48 hours - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. No sensitizing potential was found under the test conditions.
- Executive summary:
The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. A sensitization study was conducted using white Pirbright guinea pigs weighing approx. 250 gm at the start of the study. Animals were housed 2/cage in macrolon plastic cages. Bedding was from pure spuce-, fir- or pine-wood, dried and disdusted. Fluorescent lighting was on 12 hr daily, temperature was 21 C, and relative humidity, 45 to 55%. Food and water was provided ad libitum. After an acclimatization period of 7 days, animals were divided into two groups of 20 female animals (test group) and 10 female animals (control group). Prior to treatment, the left shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm). 0.5 mL of the test substance was applied undiluted to a 2 x 2 cm gauze pad. The patches were placed on the clipped left shoulder of each animal of the test group and secured with a wrapping of Elastoplast. Then the animals were immobilized in restrainers for 6 hours. After that time the patches were taken off. The procedure was repeated at the same side once weekly during the next two weeks for a total of three 6 hr exposures. After the last induction exposure, the animals were left untreated for 2 weeks before primary challenge. The animals previously exposed during the induction period as well as the previously untreated control animals were treated following the same patching procedure as for induction but the patches were applied to the freshly clipped right side that has not been treated before. 24 hours after the primary challenge all animals were depilated on the right side. The test sites were graded 6, 24 and 48 hours after the depilation by comparing the treated test animals with the animals of the control group. Any signs of erythema and other lesions were recorded. No skin sensitizing potential was observed during the study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitizing potential of the test item was tested in a Buehler Test, using 20 % of the test substance in peanut oil. This test concentration was probably close to the irritation threshold. The substance has proven to be skin irritating in a tested purity of 99.6 %. The sensitization study was conducted using white Pirbright guinea pigs weighing approx. 250 g at the start of the study. After an acclimatization period of 7 days, animals were divided into two groups of 20 female animals (test group) and 10 female animals (control group). Prior to treatment, the left shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm). 0.5 mL of the test substance was applied undiluted to a 2 x 2 cm gauze pad. After the last induction exposure, the animals were left untreated for 2 weeks before primary challenge. 24 hours after the primary challenge all animals were depilated on the right side. The test sites were graded 6, 24 and 48 hours after the depilation by comparing the treated test animals with the animals of the control group. Any signs of erythema and other lesions were recorded. No skin sensitizing potential was observed during the study sensitizing.
In addition, other substances (2-phenylethanol (CAS 60-12-8), 3-(2,2-dimethyl-3-hydroxypropyl)toluene (CAS 103694-68-4), Methyl-1-phenyl-propan-2ol (CAS 100-86-7), 3-Phenyl-1-propanol (CAS 122 -97 -4)) belonging to the same group of phenyl alcohols have proven to be non-skin sensitizer. All the substances contain the following functional groups: a primary alcohol group adjacent to carbon chains with only small differences in chain length and an aromatic group. Because of comparable structural characteristics and identical functional groups of the target and the source substances it can be presumed that their toxicological properties are similar as shown below.
2-phenylethanol (CAS 60-12-8) was tested in a study according to OECD guideline 429. No skin sensitizing effects were determined (ECHA disseminated dossier). The substance was tested in a purity of 99.9 %. 3-(2,2-dimethyl-3-hydroxypropyl)toluene (CAS 103694-68-4) was tested in an OECD guideline 406 study (maximization test) in guinea pigs. The test substance was not classified for skin sensitisation (ECHA disseminated dossier). Methyl-1-phenyl-propan-2ol (CAS 100-86-7) was tested undiluted in an open epicutaneous test with guinea pigs. No skin sensitizing effects were determined. Same results were observed in another open epicutaneous test with guinea pigs testing the substance in induction concentrations of 100%, 30%, 10%, 1% and 0.3%. 3-Phenyl-1-propanol (CAS 122-97-4) showed also no skin sensitizing effects based on OECD guideline in-vitro skin sensitization data and human patch data.
Conclusion: No skin sensitizing potential was determined in all substances. The performed studies were reliable and standardized test systems. They can be used to predict skin sensitization in an adequate and realistic way. These results are in-line with the result of the target substance observing no skin sensitizing potential.
Migrated from Short description of key information:
The skin sensitising potential of the test item was tested in a Buehler test. No skin sensitizing effects were observed in the study.
Justification for selection of skin sensitisation endpoint:
No guideline and no GLP study, unclear if highest non irritating dose was used, probably technichal pure quality was tested
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.