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Skin sensitisation

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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
Qualifier:
according to
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.
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
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
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
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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 group
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 group
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
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.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2006-08-30 until 2006-10-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to internationally accepted testing guideline, well documented
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was performed for outside EU.
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 Makrolon 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
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%
Route:
epicutaneous, occlusive
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%
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
Challenge controls:
see above B. Challenge exposure
Positive control substance(s):
yes
Remarks:
Alpha-hexylcinnamaldehyde (regular historical positive control in the laboratory)
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study 2-butyloctan-1-ol is not sensitising.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
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
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
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.
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
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 %
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
Positive control results:
Frequency of sensitisation at 24 h 70%, at 48 h 70% and at 72 h 60%.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
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
Remarks on result:
other: Reading:
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Data on skin sensitising are available for 2-butyloctan-1-ol (C12), 2 -octyldodecan-1-ol (C20) and a mixture of the two C20 isomers 2-octyldodecan-1-ol and 2 -hexyltetradecan-1-ol. All substances showed no skin sensitising effects in the guinea pig. As all substances of the category of Guerbet alcohols have the same structure with no additional functional groups the whole category is regarded as not sensitising.

Justification for classification or non-classification

Available data are conclusive but not sufficient for classfication of 2 -octyldodecan-1-ol with regard to skin sensitisation.

There are data lacking for the classification of 2 -octyldodecan-1-ol with regard to respiratory sensitisation.