1H-Indole-6-carboxylic acid, 3-cyclopentyl-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

3-cyclopentyl-1H-indole-6-carboxylic acid

Cas Number:

494799-36-9

Molecular formula:

C14 H15 N O2

IUPAC Name:

3-cyclopentyl-1H-indole-6-carboxylic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): CD 6002 SE
- Physical state: solid
- Analytical purity: 99.7 %
- Stability under test conditions: The test substance appeared to be stable under the conditions of the study; no evidence of instability was observed.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Frederick, Maryland, U.S.A.
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: 18.5 - 23.3 g
- Housing: Each mouse was housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified Rodent LabDiet 5002 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum of 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 : 12
:

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

1, 5, 10, 25 %

No. of animals per dose:

5 animals per dose

Details on study design:

- Criteria used to consider a positive response: Statistical significant increase in cell proliferation in the test concentration groups compared to the
vehicle control group and / or SIs greater than or equal to 3.0 indicated a positive response.

Positive control substance(s):

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

Results and discussion

Positive control results:

A 25 % concentration of the positive control, HCA, produced a dermal sensitization response in mice.
DPM = 4229.20
SI = 5.94

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Concentration 1 % SI = 0.89 Concentration 5 % SI = 1.68 Concentration 10 % SI = 1.20 Concentration 25 % SI = 1.24

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Concentration 1 % DPM = 563.80 Concentration 5 % DPM = 1061.40 Concentration 10 % DPM = 755.40 Concentration 25 % DPM = 782.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Based on the data, CD 6002 SE is not a dermal sensitizer.

Executive summary:

The objective of this study was to evaluate the potential of CD 6002 SE to produce a dermal sensitization response in the mice using the local lymph node assay (LLNA). Five groups of 5 female mice were dosed for 3 consecutive days with 0% (vehicle control ), 1%, 5%, 10 % or 25 % CD 6002 SE on both ears. N,N-dimethylformamide was used as the diluting vehicle. One group of five female mice was

dosed for 3 consecutive days with 25 % hexylcinnamaldehyde (HCA) in 4:1 acetone:olive oil (AOO) as a positive control and one group of five female mice was dosed for 3 consecutive days with AOO as positive control vehicle. On test day 5 of the assay, mice received ³H-Thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance group was than evaluated and compared to the vehicle control group.

No statistically significant differences in mean body weight and body weight gains compared to the vehicle control group were observed ant any test concentration. No clinical signs of toxicity were observed in the study.

No statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at any test concentration. Stimulation indexes less than 3.0 were observed at all test concentrations of CD 6002 SE. Therefore, the EC3 value for the test substance under the conditions of this study was not calculable. A 25 % concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with CD 6002 SE. Under the conditions of this study , CD 6002 SE did not produced a dermal sensitization response in mice.

Based on these data, CD 6002 SE is not a dermal sensitizer.