Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 251-110-2 | CAS number: 32582-32-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-03-15 until 1999-04-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to internationally accepted testing guideline, well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes.
Test material
- Reference substance name:
- Isofol 20 H
- IUPAC Name:
- Isofol 20 H
- Reference substance name:
- alcohol mixture 1:1 of 2-Octyl-1-dodecanol and 2-Hexyl-1-tetradecanol
- IUPAC Name:
- alcohol mixture 1:1 of 2-Octyl-1-dodecanol and 2-Hexyl-1-tetradecanol
- Details on test material:
- - Name of test material: ISOFOL 20 H
- Molecular formula: C20H42O
- Molecular weight: 298
- Composition of test material: alcohol mixture 1:1 of 2-Octyl-1-dodecanol (CAS 5333-42-6) and 2-Hexyl-1-tetradecanol (no CAS-No.)
- Substance type: not mentioned
- Physical state: liquid
- Analytical purity: 98.1 %
- Impurities: not mentioned
- Lot/batch No.: Toe 9/033
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: Pure: approx. 24 months; In solvent: stable for at least 2 hours in water, PEG, CMC, organic solvents, DMSO, propylene glycol, corn oil
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 4-5 weeks
- Weight at study initiation: 301 - 311 g
- Housing: The animals were kept in groups in Terluran cages on altromin saw fiber bedding. max. group size 10 animals
- Diet: ad libitum, Altromin 3122 maintenance diet for guines pigs, rich in crude fiber, totally-pathogen-free-TPF
- Water: ad libitum, drinking water, municipal residue control, microbiol. controlled periodically
- Acclimation period: not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 100 %; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Concentrations used for challenge: 100 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 100 %; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Concentrations used for challenge: 100 %
- No. of animals per dose:
- test group: 10 animals
control group: 5 animals - Details on study design:
- RANGE FINDING TESTS: Yes, Three animals were topically treated with different concentrations of the test item.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 ml); 2nd exposure: epicutaneous for 48 hours; evaluation after 1 and 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Test group: dermal: 100 % test substance applied to the test area and held in contact by an occlusive dressing
- Control group: Cottonseed Oil
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with 0.5 ml sodium lauryl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks
- Concentrations: 100 % test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance
- Control group: Cottonseed Oil
- Site: test substance of the left flanks, control group to the right flanks (intrspecific control)
- Concentrations: 100 %
- Evaluation (hr after challenge): 24, 48 and 72 hours after application - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- reliability checks were performed in Feb/Mar 1999 with Mercaptobenzothiazole (CAS 149-30-4)
Results and discussion
- Positive control results:
- Frequency of sensitisation at 24 h 70%, at 48 h 70% and at 72 h 60%.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 15 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitisation rate after application of the test substance was 0 %. Under the test conditions described below the mixture of 2-octyldodecan-1-ol and 2-hexyltetradecan-1-ol is not sensitising.
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.
