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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2013 - July 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
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 UK Ltd., Oxon, UK.
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: The animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to mains food was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 to 18.00) and twelve hours darkness
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5%, 10% and 25% v/v.
No. of animals per dose:
Preliminary screening test: 2 female mice
1 at 25% v/v and 1 at 50% v/v.

Main test:
5%: 4 female mice
10%: 4 female mice
25%: 4 female mice
Details on study design:
RANGE FINDING TESTS:
- Irritation: The mouse treated at a concentration of 50% v/v in acetone/olive oil 4:1 showed signs of toxicity on Day 2 including haunched posture, lethargy and ptosis.
- Irritation: No signs of systematic toxicity or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted in the mouse at a concentration of 25% v/v in acetone/olive oil 4:1.
- Based on this information the dose level selected for the main test were 25%, 10% or 5% v/v in acetone/olive oil 4:1.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Estimation of the proliferation response of lymph node cells.
- Criteria used to consider a positive response: The stimulation index is expressed as the mean radioactive incorporation treatment group divided by the mean radioactive incorporation of the vehicle control group. The test material will be regarded as a sensitizer if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer."

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated at concentrations of 25%, 10% or 5% v/v in acetone/olive oil 4:1. The preliminary screening test suggested that the test material would produce a systemic toxicity response or excessive local skin irritation at a concentration of 50% v/v. 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.
A further group of four mice received the vehicle alone in the same manner.
Key result
Parameter:
SI
Value:
4.52
Test group / Remarks:
5% (v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
6.49
Test group / Remarks:
10% (v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
7.63
Test group / Remarks:
25% (v/v) in acetone/olive oil 4:1

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Body weight change of the test animals between Day 1 and Day 6 was comparable to those observed in the corresponding control group animals over the same period.

Interpretation of results:
sensitising
Conclusions:
Test material was considered a sentitizer under the conditions of the study.
Executive summary:

Test material was considered a sentitizer under the conditions of the study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation:


In an in vivo study according to EU Method B.42 (Skin sensitisation: Local lymph node assay (LLNA)) the test material is considered to be a skin sensitiser (Harlan Laboratories Limited, 2013).

Justification for classification or non-classification

The skin sensitisation potential of the registered substance was investigated in accordance with the OECD Testing Guideline 429. It was concluded that the substance met the criteria for classification as Skin Sens 1; H317 according to Regulation (EC) No 1272/2008.