Registration Dossier
Registration Dossier
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EC number: 246-278-9 | CAS number: 24468-13-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Reference Type:
- publication
- Title:
- RIFM fragrance ingredient safety assessment, 2-ethyl-1-hexanol, CAS registry number 104-76-7
- Author:
- Api A.M. et al.
- Year:
- 2 016
- Bibliographic source:
- Food and Chemical Toxicology, 97, S147-S156
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:
- Older study
Test material
- Reference substance name:
- 2-butyloctan-1-ol
- EC Number:
- 223-470-0
- EC Name:
- 2-butyloctan-1-ol
- Cas Number:
- 3913-02-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- 2-butyloctan-1-ol
- Details on test material:
- - State of aggregation: liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: A68263
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 358 - 367 g (pretest group); 345- 416 g (control and test group)
- Housing: individually in Makroion cages type IV with standard softwood bedding
- Diet ( e.g. ad libitum): Provimi Kliba 3418 libitum, supplied by Provimi Klima, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 50%; dermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 50% test substance in a mixture of FCA
and physiological saline (1 :1)
- Concentrations used for challenge: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 50%; epidermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 50% test substance in a mixture of FCA
and physiological saline (1 :1)
- Concentrations used for challenge: 50%
- No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: intradermal: 50% v/v in physiological saline
- Concentration in Freunds Complete Adjuvants (FCA): 50% test substance in a mixture of FCA and physiological saline (1 :1)
- Test group: dermal: 0.3 ml test substance (2 x 4 cm patch)
- Control group: 0.3 ml sesame oil (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: pretreatment and day 22 challenge treatment
- Duration: removal of patches after 48 hours
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (3 x 3 cm patch)
- Control group: test substance (3 x 3 cm patch)
- Site: left flanks
- Concentrations: 50% v/v
- Evaluation (hr after challenge): 24 and 48 hours after application - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- All test animals showed discrete/patchy to moderate/confluent erythema with/without scales at the 24- and 48-hour reading after the challenge treatment with ALPHA-HEXYLCINNAMALDEHYDE at 3 % (w/w) in PEG 300. Discrete/patchy erythema was observed in two out of 5 control animals at the 24-hour reading when treated under the same conditions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 3%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 3%
- No. with + reactions:
- 10
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study 2-butyloctan-1-ol is not sensitising.
- Executive summary:
The Maximization-Test was performed in 30 (20 test and 10 control) female albino Dunkin Hartley guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 50 % dilution of the test item in sesame oil and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item one week after the intradermal induction. The animals of the control group were intradermally induced with sesame oil and FCA/physiological saline and epidermally induced with sesame oil under occlusion.Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 50 % in sesame oil and sesame oil alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
Except one animal of the control group showing emaciation and dehydratation during the acclimatization period, no toxic signs were evident in the guinea pigs of the control or test group.
Except one control animal which had to be killed in extremis during the acclimatization period no deaths occurred during the course of the study.
None of the control and test animals showed skin reactions after the challenge treatment with ISOFOL 12 at 50 % (w/w) in sesame oil.
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