Aluminium tributanolate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

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

Author:

Ryan et al.

Year:

2000

Bibliographic source:

Contact Dermatitis. 2000 Aug;43(2):95-102.

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

Specific details on test material used for the study:

100%

In vivo test system

Test animals

Species:

mouse

Strain:

CBA:J

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley Inc, Indianapolis IN, USA
- Age at study initiation: 6-12 weeks
- Weight at study initiation: no data


ENVIRONMENTAL CONDITIONS: no data

Animals were housed, fed and handled according to the USA Animal Welfare Act

Study design: in vivo (LLNA)

Vehicle:

other: distilled water

Concentration:

0, 5, 10 and 20% v/v

No. of animals per dose:

5 females

Details on study design:

PRE-SCREEN TESTS: no data on pre-test and selection of the doses

MAIN STUDY:
Mice were treated for 3 consecutive days with 25 uL of the concentration at the dorsal site of the ears. After 5 days mice were injected with 3H-methylthymidine in PBS (20 uCi). Five hours thereafter mice were euthanised and draining auricular lymphnodes were removed (pooled per animal) and single cell suspensions were prepared by mechanical disaggregation through a nylon mesh (100 um pore size). Cell suspension were washed, precipitated with TCA and left overnight (at 4 degr C). After further preparation and suspension in scintillation cocktail the 3H-methylthymidine incorporation was measured by beta-scintillation counting (expressed as DPM/mouse)

Positive control substance(s):

other: the test contained several substances with positive results

Statistics:

NA

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

other: DPM

Value:

366

Variability:

± 44

Test group / Remarks:

control

Remarks on result:

other: SI =1

Results 2

Parameter:

other: DPM

Value:

598

Variability:

± 157

Test group / Remarks:

5% group

Remarks on result:

other: SI = 1.6

Results 3

Parameter:

other: DPM

Value:

451

Variability:

± 17

Test group / Remarks:

10% group

Remarks on result:

other: SI = 1.2

Results 4

Parameter:

other: DPM

Value:

530

Variability:

± 91

Test group / Remarks:

25% group

Remarks on result:

other: SI = 1.4

Results 5

Parameter:

SI

Value:

1

Test group / Remarks:

control

Results 6

Parameter:

SI

Value:

1.6

Test group / Remarks:

5%

Results 7

Parameter:

SI

Value:

1.2

Test group / Remarks:

10%

Results 8

Parameter:

SI

Value:

1.4

Test group / Remarks:

20%

Cellular proliferation data / Observations:

No additional data available

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not sensitizing in the LLNA test

Executive summary:

A test following the protocol of OECD 429 was performed in mice treated with 5, 10 and 25% of the substance in distilled water during 3 consecutive days. On day 5 animals were treated with 3H-methylthymidine and the amount of 3H-TdR was measured in a cell suspension derived from the auricular lymphnodes (pooled/animal). The stimulation index was 1.6, 1.2 and 1.4 at 5, 10 and 25%. This is indicative for no sensitizing effects.