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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
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

Constituent 1
Chemical structure
Reference substance name:
methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
Cas Number:
494799-38-1
Molecular formula:
C16 H19 N O2
IUPAC Name:
methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): CD 6003 XX
- Physical state: solid
- Stability under test conditions: The test substance appeared to be stable under the conditions of the study; no evidence of instability was observed.
- Analytical purity: 99.7 %

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: 18.4 - 23.3 g
- Housing: All mice were 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: 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:
5, 10, 25 and 50 %
No. of animals per dose:
5 animals per dose
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Statistically significant increase in cell proliferation in the test concentration groups compared to the
vehicle control group and/or SIs of 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 dermal sensitization response in mice.
DPM = 4299.20
SI = 5.94

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Concentration 5 % SI = 1.75 Concentration 10 % SI = 2.08 Concentration 25 % SI = 1.80 Concentration 50 % SI = 2.23
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Concentration 5 % DPM = 1106.60 Concentration 10 % DPM = 1313.40 Concentration 25 % DPM = 1136.20 Concentration 50 % DPM = 1411.80

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Based on the data, CD 6003 XX is not a dermal sensitizer.
Executive summary:

The objective of this study was to evaluate the potential of CD 6003 XX to produce dermal senitization response in mice using the local lymph node assay ( LLNA ). Five groups of 5 female mice were dosed for 3 consecutive days with 0 % ( vehicle control ), 5 %, 10 %,

25 % and 50 % CD 6003 XX on both ears.N,N-dimethylformamide was used as the diluting vehicle. One group of 5 female mice was dosed for 3 consecutive days with 25 % hexylcinnamaldehyde( HCA ) in 4 : 1 acetone : olive oil ( AOO ) as positive control and one group of 5 female mice was dosed for 3 consecutive days with AAO as positive vehicle control. 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 then evaluated and compared to the vehicle control group.

No statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at any test concentration. Stimulation indexes of less than 3.0 were observed at all test concentrations of CD 6003 XX. 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 dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with CD 6003 XX. Under the conditions of this study, CD 6003 XX did not produce a dermal sensitization response in mice.

Based on the data, CD 6003 XX is not a dermal sensitizer.

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