Registration Dossier

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:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.

Applicant's summary and conclusion