1-chloro-2,5-dimethoxybenzene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-03-03 to 2009-03-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD and GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

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)

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-2,5-dimethoxybenzene

EC Number:

218-267-9

EC Name:

1-chloro-2,5-dimethoxybenzene

Cas Number:

2100-42-7

Molecular formula:

C8H9ClO2

IUPAC Name:

2-chloro-1,4-dimethoxybenzene

Details on test material:

- Name of test material (as cited in study report): Chlor-dimethylhydrochinon

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., Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:group
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness will be used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

25, 50, and 100%

No. of animals per dose:

4

Positive control substance(s):

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

Statistics:

EC3 = (a-c) [(3-d)/(b-d)] + c
a,b,c,d = Co-ordinates of the two pairs of data lying immediately above and below the S.I. value of 3 on the LLNA dose response plot.

Results and discussion

Positive control results:

The positive control experiment proved the sensitivity of the assay as expected.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 25 %: 1.58 50%: 1.62 100%: 2.50

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM measured: 0%: 2917 25 %: 4594 50%: 4724 100%: 7266

Any other information on results incl. tables

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test item Chlor-dimethylhydrochinon was not a skin sensitiser under the described conditions.

Executive summary:

In the study the test item Chlor-dimethylhydrochinon dissolved in acetone : olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 25, 50, and 100%. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. A relevant increase in ear weights (punches) was not observed and a statistically signifigance of the ear weight was not determined. In this study Stimulation Indices (S.I.) of 1.58, 1.62, and 2.50 were determined with the test item at concentrations of 25, 50, and 100% in acetone : olive oil (4+1), respectively.

The test item Chlor-dimethylhydrochinon was not a skin sensitiser in this assay.