Butan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Activity of human contact allergens in the murine local lymph node assay

Author:

Ryan CA et al.

Year:

2000

Bibliographic source:

Contact dermatitis,Vol.43, 95-102

Reference 2

Reference Type:

publication

Title:

Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods

Author:

Gerberick GF et al

Year:

2005

Bibliographic source:

Dermatitis Vol 16, No 4, pp 157-202

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Butan-1-ol

EC Number:

200-751-6

EC Name:

Butan-1-ol

Cas Number:

71-36-3

Molecular formula:

C4H10O

IUPAC Name:

butan-1-ol

Test material form:

liquid

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/J mice strain and CBA/Ca strain

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CBA/J strain mice:Harlan Sprague Dawley, Inc., Indianapolis, IN or Jackson
Laboratories, Bar Harbor, ME; female
CBA/Ca strain mice: Harlan Olac Bicester, Oxfordshire, UK
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] not specified
- Age at study initiation:6-12 weeks

Study design: in vivo (LLNA)

Vehicle:

other: distilled water

Concentration:

5%, 10% and 20% (v/v) in distilled water

No. of animals per dose:

n=5 (Laboratory A) or n=4 (Laboratory B and C)

Details on study design:

- groups of mice were treated 1x a day for 3 consecutive days on the dorsum of both ears with 25 µL of
1 of 3 concentrations of test material or with vehicle
- 5 days after initial treatment, all mice were injected intravenously, via the tail vein, with 250 µL PBS
containing 20 mCi of 3H-methylthymidine (3H-TdR; specific activity 5.0 Ci/mmol for Laboratory A, 2.0 Ci/mmol for Laboratories B and C, respectively).
- 5 h later, mice were euthanised and draining auricular lymph nodes were removed and pooled for each
individual mouse (Laboratory A) or for each experimental group (Laboratories B and C)
- single cell suspensions were prepared
- samples were centrifuged, resuspended in 1 mL 5% TCA and transferred to 10 mL of
scintillation cocktail
- 3H-TdR incorporation was measured by b-scintillation counting and expressed
as disintegrations per min (dpm) per individual mouse (Laboratory A) or as dpm per node for each experimental group (Laboratories B and C)

Stimulation indices (SI) for each experimental group were determined as the increase in 3H-TdR incorporation relative to concurrent vehicle treated control group. Positive: 3-fold or greater increase in proliferation, compared with the concurrent vehicle control, obtained at 1 or more test concentrations.

Results and discussion

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

vehicle water

Results 2

Key result

Parameter:

SI

Value:

1.6

Test group / Remarks:

5% (v/v)

Results 3

Key result

Parameter:

SI

Value:

1.2

Test group / Remarks:

10% (v/v)

Results 4

Key result

Parameter:

SI

Value:

1.4

Test group / Remarks:

20% (v/v)

Cellular proliferation data / Observations:

vehicle water: 366 ± 44 mean dpm (± SEM)
5% (v/v) 1-butanol: 598 ± 157 mean dpm (± SEM)
10% (v/v) 1-butanol: 451 ± 17 mean dpm (± SEM)
20% (v/v) 1-butanol: 530 ± 91 mean dpm (± SEM)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met