Hexan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Reasonable reporting of a modified Draize test, result reporting limited. Test sample not fully characterised. Controls only included at rechallenge. On a related material.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1978

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

Justification for non-LLNA method:

An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler/Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.

Test material

Test material information

Constituent 1

Reference substance name:

Hexan-1-ol

EC Number:

203-852-3

EC Name:

Hexan-1-ol

Cas Number:

111-27-3

Molecular formula:

C6H14O

IUPAC Name:

hexan-1-ol

Test material form:

not specified

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)

Induction

Route:

intradermal

Vehicle:

not specified

Concentration / amount:

2.5 times the injection challenge concentration of 0.1%

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

Challenge 1

No.:

#1

Route:

intradermal

Vehicle:

not specified

Concentration / amount:

0.1%

Adequacy of challenge:

highest non-irritant concentration

Challenge 2

No.:

#1

Route:

epicutaneous, open

Vehicle:

not specified

Concentration / amount:

10%

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

Preliminary test: 4 animals
Main test: 10 animals

Details on study design:

- Preliminary test: 4 animals were injected intradermally in their shaved flanks with 0.1 ml of hexan-1-ol in appropriate solvent (not specified) at different concentrations (not specified). The reactions were examined for size, erythema and oedema at 24 hours post injection and the concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration. In addition to intradermal injection, topical application of 0.1 ml of hexan-1-ol at different concentrations (not specified) in appropriate solvent (not specified) were applied on the shaved flanks of 4 guinea pigs. The erythema skin reactions were examined at 24 hours post application and the highest concentration, which caused no irritation, was selected as the application challenge concentration.

For the main skin sensitisation study, 0.25%, 0.1% and 10% solutions were the chosen concentrations for the intradermal induction, intradermal challenge and topical challenge, respectively, to be tested onto the skin of 10 guinea pigs per dose. No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation.

Induction and challenge: During the induction phase, 0.1 ml of hexan-1-ol at 0.25% concentration (2.5 times the injection challenge concentration of 0.1%) were injected intradermally to 10 guinea pigs at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. Two weeks later, each animal was challenged intradermally in one flank and topically in the other with 0.1 ml of hexan-1-ol at the respective injection challenge concentration of 0.1& and application challenge concentration of 10%. Skin reactions were assessed at 24 hours post challenge and apparent sensitisation reactions confirmed 7 days later by a second challenge with controls included. If no skin sensitisation was observed following the first challenge, the induction and challenge procedures were repeated, but with confirmatory challenge controls. The challenge controls were not induced but treated in a similar way as test animals at challenge.

Challenge controls:

Not used at first challenge. Untreated challenge controls used at follow-up challenge applications.

Positive control substance(s):

not specified

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)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1% intradermal; 10% topical

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Individual animal data were not presented.

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.1% intradermal; 10% topical

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Individual animal data were not presented.

Results 3

Group:

positive control

Remarks on result:

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

Results 4

Group:

negative control

Remarks on result:

other: Individual animal data were not presented.

Any other information on results incl. tables

Individual animal data were not presented.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo skin sensitisation study, conducted by a non-adjuvant modified Draize test procedure (reliability 2) and prior to GLP, hexan-1-ol was concluded to be not a skin sensitiser in guinea pigs following intradermal and topical challenge after 2 series of induction applications.