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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is a read across from hexanol (CAS 111-27-3). Reasonable reporting of a modified Draize test, result reporting limited. Test sample not fully characterised. Controls only included at rechallenge.

Data source

Reference
Reference Type:
publication
Title:
The sensitization potential of some perfume ingredients tested using a modified Draize procedure.
Author:
Sharp D W
Year:
1978
Bibliographic source:
Toxicology 9(3):261-271.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin sensitisation test in guinea pigs. Range finding (preliminary irritation) test by intradermal injection and topical application. Sensitisation test with induction by intradermal injection followed by intradermal and topical challenge. Repeated induction and rechallenge if negative results.
GLP compliance:
not specified
Type of study:
other: modified Draize test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hexanol
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: random sample from commercial batch

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: approximately 350 g
- Housing: wire mesh cages, two animals (same sex) per cage
- Diet (e.g. ad libitum): pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data

IN-LIFE DATES: no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
Concentrations used for induction: Based on a primary irritation screen the concentration used was 2.5 times the injection challenge concentration (the concentration giving slight barely perceptible irritation with no oedema), 0.25%.
Concentrations used for challenge: 0.1% intradermally ad 10% topically
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
Concentrations used for induction: Based on a primary irritation screen the concentration used was 2.5 times the injection challenge concentration (the concentration giving slight barely perceptible irritation with no oedema), 0.25%.
Concentrations used for challenge: 0.1% intradermally ad 10% topically
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:
In the preliminary irritation test to determine the injection challenge concentration (ICC), four animals of a single sex were injected intradermally on shaved flanks with 0.1 ml aliquots of a range of concentrations of test material 'in a suitable solvent'. Reactions were examined for size, erythema and oedema after 24 hours, and the concentration resulting in slight but perceptible irritation in the absence of oedema was selected as the ICC.

The same method was used for the topical range-finding test, except solutions were applied dermally. The application challenge concentration (ACC) was the highest concentration causing no irritation.

0.25%, 0.1% and 10% solutions were chosen for the intradermal induction, intradermal challenge and topical challenge respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4 simultaneously
- Exposure period: single timepoint
- Test groups: 1
- Control group: 0
- Site: 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications: 4 injections at one timepoint
- Concentrations: 0.25%, 0.1 ml

B. CHALLENGE EXPOSURE
- No. of exposures: 2 simultaneously, one intradermal, one topical
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 hours (topical)
- Test groups: 1
- Control group: 0
- Site: 2 shaved flanks, one intradermal, one topical
- Concentrations: 0.1% intradermal, 10% topical without occlusion
- Evaluation (hr after challenge): 24

OTHER:
- Rechallenge: negative at challenge, therefore a repeat set of induction applications was carried out followed by challenge at 14 days and rechallenge (with controls) 7 days later.
- No adjuvant was used in the study.
- Hair was shaved from both flanks with Oster animal clippers (size 40 blades) before application of test material.
- Reactions were examined under a Philips colour-matching unit with three Philips 40W Actinic Blue 05 fluorescent tubes and three Philips 40W White 35 fluorescent tubes.
- Each injection reaction was given a total score based on size ('2 largest diameters'), erythema and oedema. A reaction was considered positive if its total score was 'significantly greater' than the average total score for control reactions. Topical application reactions were 'scored on a 0 to +++ scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls'.

Challenge controls:
No controls for challenge at 14 days; rechallenge (with 4 controls) 7 days later
Positive control substance(s):
not specified
Remarks:
series of compounds tested, some positive for skin sensitisation

Results and discussion

Positive control results:
No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1% intradermal; 10% topical
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% intradermal; 10% topical. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Reading:
rechallenge
Group:
test group
Dose level:
0.1% intradermal, 10% topical
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: rechallenge. Group: test group. Dose level: 0.1% intradermal, 10% topical. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.

Any other information on results incl. tables

Individual animal data were not presented.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a reliable study, conducted by a non-adjuvant modified Draize procedure (reliability 2), hexan-1-ol was not a skin sensitiser in guinea pigs following intradermal and topical challenge after 2 series of induction applications. The result is a read across from hexanol (CAS 111-27-3).

Classification: not sensitizing