1-Butanol, 3-amino-, (3R)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Justification for data waiving:

other:

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

3-Amino-butan-1-ol

IUPAC Name:

3-Amino-butan-1-ol

Constituent 2

Reference substance name:

2867-59-6

Cas Number:

2867-59-6

IUPAC Name:

2867-59-6

Details on test material:

- Name of test material (as cited in study report): 3-Amino-butan-1-ol
- Physical state: Colorless, clear liquid
- Analytical purity: 93.6% corr.area-%
- Lot/batch No.: 37794-117 (02/1302/24)

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Horst / The Netherlands
- Age at study initiation: 9 - 10 weeks (beginning of treatment)
- Weight at study initiation:
- Housing: group (Makrolon Type II (pre-test) / III (main study), with wire mesh top)
- Diet (e.g. ad libitum): ad libitum, 2018C Teklad Global 18% protein rodent diet (certified)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 42.8-65%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

0.25, 0.5, 1.0 %

No. of animals per dose:

5

Details on study design:

The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation (as determined by three pre-experiments).

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: In this study Stimulation Indices (S.I.) of 1.21, 1.28 and 1.69 were determined with the test item at concentrations of 0.25, 0.5 and 1% (w/w) in DMF.

Any other information on results incl. tables

 Calculation of Stimulation Indices per Dose Group

Test item concentration	Group Calculation
	Mean DPM per animal (2 lymph nodes)^a)	SD	S.I.
Vehicle Control Group (DMF)	564.6	54.4	1.00
0.25% 3-Amino-butan-1-ol	684.0	154.1	1.21
0.5% 3-Amino-butan-1-ol	722.8	343.3	1.28
1% 3-Amino-butan-1-ol	955.8	297.3	1.69

The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On day 3 and 4, the animals treated with a test item concentration of 1% showed an erythema of the ear skin (score 1). Animals treated with 0.25 or 0.5% test item concentration did not show any signs of local skin irritation. A statistically significant or biologically relevant increase in ear weights was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cut-off value (1.1) of the ear weight index for a positive response regarding ear skin irritation reported for BALB/c mice (see Ref. 9) was not exceeded in any of the treated groups.

A statistically significant or biologically relevant increase in lymph node weights or –cell counts was also not observed in any of the test item treated groups in comparison to the vehicle control group. For BALB/c mice, a cut-off value for the lymph node cell count index of 1.55 was reported for a positive response (See Ref. 8). The indices determined for the lymph node cell count did not exceed this threshold.

The test item 3-Amino-butan-1-ol was thus not a skin sensitizer under the test conditions of this study.