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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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:

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)

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

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)

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.

 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no studies available for (R)-3 -Amino-butan-ol, only for the racemat 3-Amino-butan-1 -ol.

In this study the test item 3-Amino-butan-1-ol was assessed for its skin sensitizing potential using the Local Lymph Node Assay (LLNA, OECD 429 ) in mice. Test item solution at different concentrations was prepared in the vehicle DMF. For this purpose a local lymph node assay was performed using test item concentrations of 0.25, 0.5 and 1% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation. 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, respectively. The test item 3-Amino-butan-1-ol was thus not a skin sensitizer under the test conditions of this study.

Migrated from Short description of key information:
LLNA: not sensitizing

Justification for selection of skin sensitisation endpoint:
only one study available

Justification for classification or non-classification

No need for classification according to Annex VI of Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.