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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2008-01-02 to 2008-01-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2010
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol
EC Number:
608-245-0
Cas Number:
28770-01-6
Molecular formula:
C8H17NO2
IUPAC Name:
2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol
Test material form:
other: liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK and Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (Certified Rat and Mouse Diet) was allowed throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100 % (undiluted), 50 % or 25 % (v/v), 0 %
No. of animals per dose:
4
Details on study design:
PRELIMINARY SCREENING TESTS:
- Concentration: 25 µL of undiluted test material
- Irritation/ Lymph node proliferation response: The test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of the test method: LLNA
- Criteria used to consider a positive response: Stimulation Index > 3

TREATMENT PREPARATION AND ADMINISTRATION: The mice were treated by daily application of 25 µL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
15.04
Test group / Remarks:
25 % (v/v)
Parameter:
SI
Value:
13.07
Test group / Remarks:
50 % (v/v)
Key result
Parameter:
SI
Value:
12.52
Test group / Remarks:
100 % (v/v)
Parameter:
other: disintegrations per minute (DPM)
Value:
7 908.36
Test group / Remarks:
Vehicle
Parameter:
other: disintegrations per minute (DPM)
Value:
118 976.5
Test group / Remarks:
25 % (v/v)
Parameter:
other: disintegrations per minute (DPM)
Value:
103 377
Test group / Remarks:
50 % (v/v)
Parameter:
other: disintegrations per minute (DPM)
Value:
99 051.8
Test group / Remarks:
100 % (v/v)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test material was considered to be a sensitiser under the conditions of the test.
Executive summary:

A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002) and Method B.42 "Skin Sensitisation (Local Lymph Node Assay)" of Commission Directive 2004/73/EC.

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100 %, therefore, this concentration was selected as the highest investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the undiluted test material or the test material as a solution in acetone/olive oil 4:1 at concentrations of 25 % or 50 % (v/v). A further group of four animals was treated with acetone/olive oil 4:1 alone.

The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows: A stimulation index of greater than 3 was recorded for the three concentrations of the test material (25 % and 50 % v/v in acetone/olive oil 4:1 and 100 %). There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period. The test material was considered to be a sensitiser under the conditions of the test.