Registration Dossier
Registration Dossier
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EC number: 226-242-9 | CAS number: 5333-42-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 79/831/EWG Annex V
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted before the REACH Regulation came into force.
Test material
- Details on test material:
- - Name of test material (as cited in study report): 2-Octyldodecanol
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.:
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (D)
- Weight at study initiation: 324 g
- Housing: Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50-60
- 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:
- intradermal induction: 0.2% test substance plus Freund's adjuvants
epicutaneous induction: 5%
challenge: 0.5 and 0.75% test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- intradermal induction: 0.2% test substance plus Freund's adjuvants
epicutaneous induction: 5%
challenge: 0.5 and 0.75% test substance
- No. of animals per dose:
- 20 per dose/control
- Details on study design:
- according to 79/831/EWG Annex V
- Challenge controls:
- Yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- grade 1 erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.75%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: grade 1 erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- grade 1 erythema
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the Magnusson Kligman test design, 2-Octyldodecan-1-ol was not sensitizing to the skin.
- Executive summary:
Under the conditions of the Magnusson Kligman test design the test substance was not sensitizing to the skin.
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