(3-chloroprop-1-enyl)benzene

Endpoint summary

Description of key information

Skin sensitisation:

In a LLNA test performed according to SPL Standard Test Method 595.12, the test item was observed to be a skin sensitiser (Sanders, 2004). A K2 score was assigned to this key study.

Skin sensitisation in vitro:

An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study (initiated before October 11th 2016) is available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-02-02 to 2004-02-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

other: SPL Standard Test Method 595.12

Deviations:

not specified

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS: no data

ENVIRONMENTAL CONDITIONS: no data

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

25% or 50% v/v in acetone/olive oil and 100%

No. of animals per dose:

three groups with four animals in each group

Details on study design:

PRE-SCREEN TESTS:
- Compound solubility: no data
- Irritation: no data
- Systemic toxicity: no signs of systemic toxicity at a concentration of 100%
- Ear thickness measurements: no data
- Erythema scores: no data

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Test to control ratio greater than 3.0 indicates a ‘positive’ result.

TREATMENT PREPARATION AND ADMINISTRATION:
Three groups, each of four animals, were treated with 50 µL of the undiluted test material (25 µL per ear) 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.

Positive control substance(s):

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

other: 2,4 Dinitrobenzenesulfonic acid, sodium salt at 1%, 10%, 20% in 1% pluronic F-68 in distilled water

Positive control results:

see: any other information on results (here below)

Parameter:

SI

Value:

1.68

Test group / Remarks:

based on 4 animals of 25% v/v goup in acetone/olive oil 4:1

Parameter:

SI

Value:

4.63

Test group / Remarks:

based on 4 animals of 50% v/v group in acetone/olive oil 4:1

Parameter:

SI

Value:

6.2

Test group / Remarks:

based on 4 animals of 100% group

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA: no data

DETAILS ON STIMULATION INDEX CALCULATION: see results table above

EC3 CALCULATION: Using the data generated, an EC3 value of 36.3% was calculated.

CLINICAL OBSERVATIONS: no data

BODY WEIGHTS: no data

Positive Control Local Lymph Node Assay in the Mouse (2004)

Start Date	Finish Date	Test Material	Concentration	Vehicle	Stimulation Index^a	Classification^b
29/04/2004	05/05/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	acetone/olive oil 4:1	1.40, 2.23, 6.09	Positive
29/04/2004	05/05/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	acetone/olive oil 4:1	1.74, 2.20, 8.89	Positive
14/10/2004	26/10/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	tetrahydrofuran	1.97, 3.71, 7.82	Positive
29/09/2004	05/10/2004	2,4‑Dinitrobenzenesulfonic acid, sodium salt	1%, 10%, 20% v/v	1% pluronic F-68 in distilled water	1.03, 4.41, 13.55	Positive
27/10/2004	02/11/2004	α‑Hexylcinnamaldehyde, tech., 85%	10%, 25%, 50% v/v	cottonseed oil	1.52, 2.63, 5.07	Positive

a=        Ratio of test to control lymphocyte proliferation

b=        Stimulation index greater than 3.0 indicates a positive result

* =        Standard Test Method 595 (Pooled nodes)

·=        Standard Test Method 599 (Individual nodes)

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

The test item was considered to be a sensitiser under the conditions of the test. Based on the calculated EC3 value of 36.3% and the criteria of the CLP Regulation (EC3 value > 2%), the substance is classified as skin sensitiser category 1B (H317).

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

A local lymph node assay (LLNA) was performed to assess the skin sensitisation potential of the test item in the mouse (CBA/Ca strain). 

Following a preliminary sighting test at which there were no signs of systemic toxicity at a concentration of 100%, three groups, each of four animals, were treated with 50 µl of the undiluted test material (25 µl per ear) 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) for each treatment group was as follows: 1.68 at 25% v/v, 4.63 at 50% v/v and 6.20 at 100%. Using the generated data, an EC3 value of 36.3% was calculated. The test item was considered to be a sensitiser under the conditions of the test.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin sensitisation:

Based on the study results and the criteria of the CLP Regulation, the test item should be classified as skin sensitising substance, category 1B (H317).

Respiratory sensitisation:

No data were available to decide on the classification for respiratory sensitisation.