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Toxicological information

Skin sensitisation

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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)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD test guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: Cinilex DPP RED SR1C
Description: red powder
Batch number: A01297
Storage conditions: room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5%, 10% or 25% w/w in acetone/olive oil 4:1
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 5%: 0.99 25%: 1.13
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: vehicle: 7694.44 5%: 7593.42 25% 8718.31

Any other information on results incl. tables

Due to accidental spillage of the single cell suspension of pooled lymph node cells for the group treated with the test material at a concentration of 10%, the results obtained cannot be verified as being accurate. For this reason the results for the 10% group were not used for reporting purposes. This was considered not to affect the purpose or integrity of the study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP-study according to OECD test guideline 429 (LLNA), the registered substance was not skin sensitising.
Executive summary:

A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

Following a preliminary screening test, three groups, each of four animals, were treated with 50 p.1 (25 p1 per ear) of the test material as a suspension in acetone/olive oil 4:1 at concentrations of 5%, 10% or 25% w/w. A further group of four animals was treated with acetone/olive oil 4:1 alone.

Due to accidental spillage of the single cell suspension of pooled lymph node cells for the group treated with the test material at a concentration of 10%, the results obtained cannot be verified as being accurate. For this reason the results for the 10% group were not used for reporting purposes. This was considered not to affect the purpose or integrity of the study.

Simulation Indexes for 5% and 25 % were 0.99 and 1.13, respectively. Therefore, the test material was considered to be a non-sensitiser under the conditions of the test.