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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key 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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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:
Study was performed for outside EU.

Test material

Constituent 1
Chemical structure
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:
- Name of test material (as cited in study report): Isofol 12
- Substance type: not mentioned
- Physical state: liquid
- Lot/batch No.: A68263
- Expiration date of the lot/batch: 2010-03-29
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: at room temperature

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 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

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%; 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)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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 chemical
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 chemical
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.

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.