Reaction mass of 1,3-dichloropropene and 2-chloropropane and 2-chloropropene and 3-chloropropene

Skin sensitisation

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: The study was conducted according to O.E.C.D. Testing Guideline 429 with GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropene

EC Number:

203-457-6

EC Name:

3-chloropropene

Cas Number:

107-05-1

Molecular formula:

C3H5Cl

IUPAC Name:

3-chloroprop-1-ene

Details on test material:

As per the IUCLID5 Sections 1.1. - 1.4. for 3-chloropropene.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Animals were acquired from Harlan Laboratories UK Limited, Bicester, Oxon, UK, and were 8 - 12 wks old at study initiation. The weight range at study initiation was 15 to 23 gm. Animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Feed offered ad libitum was 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK. Tap water was supplied ad libitum. The acclimation period > 5 days. The environmental conditions were: Temperature 19 to 25 °C, Humidity 30 to 70%, Air changes (per hr): 15 and the Photoperiod (hrs dark / hrs light) was 12/12.

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

25, 50 % (v/v) in acetone/olive oil and 100 % (undiluted)

No. of animals per dose:

5

Details on study design:

The preliminary screening test suggested that 3-chloropropene would not produce excessive local irritation at the highest tested of 100%. Animals, were treated with 50 pl (25 pl per ear) of the undiluted test substance or the test substance as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of five animals was treated with acetone/olive oil 4:1 alone. A concurrent positive control test, using a
group of five animals, was also performed with the known sensitiser, a-Hexylcinnamaldehyde tech., 85%, at a concentration of 15% v/v in acetone/olive oil 4:1.

Five days after treatment the animals were injected via the tail vein with 250 uL phosphate buffered saline containing 3H-methyl thymidine at 20 uCi per mouse to label the lymph node DNA. After sacrifice the draining auricular lymph nodes were excised and processed to single cell suspensions. The radiolabeled DNA was precipated with 5% trichloroacetic. Samples were subjected to liquid scintillation counting by a Bechman LS6500 scintillation system.

Positive control substance(s):

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

Statistics:

Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships by analysis of homogeneity of variance followed by one way analysis of variance (ANOVA). In the event of a significant result from the ANOVA, pairwise comparisons were performed between control and treated groups. For homogenous datasets Dunnett's Multiple Comparison test was used and for non-homogenous datasets Dunnett's T3 Multiple Comparison Method was used.

Results and discussion

Positive control results:

a-Hexylcinnamaldehyde tech., 85%, at a concentration of 15% v/v in acetone/olive oil 4:1 induced a positive stimulation index of 6.2.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: The Stimulation Index for the 25%, 50%, 100% test substance concentrations and positive control were: 0.78, 0.75, 1.97 and 6.2 respectively.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: The mean DPM per animal for the Vehivle, 25%, 50% and 100% test substance were as follows: 1656 ±417; 1293 ±359; 1246 ±378 and 3255 ±139. respectively. Mean DPMs for the positive control were 10278 ±3234.

Any other information on results incl. tables

No adverse affects were observed concerning clinical signs or body weight effects.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Treatment with the structural analog of AC Lighe Ends, 3-chloropropene, did not induce a state of dermal sensitization in the mouse local lymph node assay up to a high concentration level of 100%.

Executive summary:

3 -Chloropropene, a structural analog for AC Light Ends was assessed for the ability to induce dermal sensitization in the mouse following an O.E.C.D. 429 Testing Guideline "Skin Sensitization Local Lymph Node Assay" with GLP compliance. Treatment with 3-chloropropene, did not induce a state of dermal sensitization in the mouse local lymph node assay up to a high concentration level of 100%. Therefore, it is anticipated that AC Light Ends will not be a dermal sensitizer in mouse LLNA system.