3-bromoanisole

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication .

Data source

Reference

Reference Type:

publication

Title:

The Toxicological Assessment of Cyclopentyl Methyl Ether (CPME) as a Green Solvent

Author:

Kiyoshi Watanabe

Year:

2013

Bibliographic source:

Molecules 2013, 18, 3183-3194

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

Skin sensitizing potential of of Cyclopentane, methoxy- was evaluated in mouse by LLNA mode.

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentane, methoxy-

EC Number:

611-360-9

Cas Number:

5614-37-9

Molecular formula:

C6H12O

IUPAC Name:

Cyclopentane, methoxy-

Specific details on test material used for the study:

Details on test material
- Name of test material (as cited in study report): Cyclopentyl methyl ether (Cyclopentane, methoxy-)
- Molecular formula: C6 H12 O
- Molecular weight : 100.159 g/mol
- Substance type: Organic
- Physical state: liquid

In vivo test system

Test animals

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Harlan UK Ltd or
Charles River UK Ltd.
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing: Each cage was made of stainless steel with stainless steel grid floors.
- Diet (e.g. ad libitum): rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18–24 °C
- Humidity (%): 40–70%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 h (06:00–18:00 or 07:00–19:00)

Study design: in vivo (LLNA)

Vehicle:

not specified

Concentration:

25, 50 and 100%

No. of animals per dose:

No data available

Details on study design:

Details on study design

PRE-SCREEN TESTS:
- Compound solubility: No data available
- Irritation: No data available
- Systemic toxicity: No data available
- Ear thickness measurements: No data available
- Erythema scores: No data available

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: The Local
Lymph Node Assay
- Criteria used to consider a positive response: The test substance is regarded as a sensitizer if at least one concentration of the chemical results in a 300% greater increase in 3HTdR incorporation compared to control values.

TREATMENT PREPARATION AND ADMINISTRATION:
In this assays, the concentration of Cyclopentane, methoxy- supplied were 25, 50 and 100%.
The proliferative response of the lymph node cells (LNC) from the draining auricular lymph node was assessed five days following the initial application, by measurement of the incorporation of 3H-thymidine by β-scintillation counting of LNC suspension.

Statistics:

No data available

Results and discussion

In vivo (LLNA)

Results

Parameter:

other: Increase in 3HTdR incorporation compared to control values.

Test group / Remarks:

120, 130 and 260% was the value observed in test group

Remarks on result:

other: No indication of skin sensitization

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA/observation

CELLULAR PROLIFERATION DATA:
The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes(test/control ratio).

DETAILS ON STIMULATION INDEX CALCULATION: No data available

EC3 CALCULATION: No data available

CLINICAL OBSERVATIONS: No data available

BODY WEIGHTS: No data available

Any other information on results incl. tables

No sensitization observed.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

Cyclopentane, methoxy- was observed for its skin sensitizing potential. In this assays, the test/control ratios obtained for 25, 50 and 100% (as supplied) v/v concentration of Cyclopentane, methoxy- were 120, 130 and 260%, respectively, which indicate that Cyclopentane, methoxy- did not show the potential to induce skin sensitization.

Executive summary:

Skin Sensitization of Cyclopentane, methoxy was observed in mouse by LLNA mode.The proliferative response of the lymph node cells (LNC) from the draining auricular lymph node

was assessed five days following the initial application, by measurement of the incorporation of 3H-thymidine by β-scintillation counting of LNC suspension. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes(test/control ratio).TheCyclopentane, methoxy-substance is regarded as a sensitizer if at least one concentration of the chemical results in a 300% greater increase in 3HTdR incorporation compared to control values.In these assays, the test/control ratios obtained for 25, 50 and 100% (as supplied) v/v were 120, 130 and 260%, respectively, which indicate that CPME did not show the potential to induce skin sensitization. ThereforeCyclopentane, methoxy-(5614-37-9 was considered to be non sensitizing to the skin.