Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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: performed in accordance with OECD and GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

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

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
-strain: CBA/CaOlaHsd
- Source: Harlan Laboratories B.V., The Netherlands
- Age at study initiation: 8-9 weeks (beginning of treatment)
- Weight at study initiation: 18.3 g to 21.5 g
- Housing: Single caging, Makrolon Type I, with wire mesh top, granulated soft wood bedding
- 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 illne ss were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial light, 12/12

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
0, 0.03, 0.3, 1.0, 3.0, 10.0 % (w/v)
No. of animals per dose:
5 animals per treatment group, 5 animals in the control group
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
EC3: 15.7% (w/v)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The S.I. were 1.06, 1.30, 1.64, 3.02 and 3.25 for concentrations of 0.03, 0.3, 1.0, 3.0 and 10.0% in DMSO (w/v) respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Results expressed as mean per group Group -- DPM per lymph node -- SI Vehicle -- 925.1 -- 1.00 0.03% -- 979.0 -- 1.06 0.3% -- 1206.9 -- 1.30 1.0% -- 1521.1 -- 1.64 3.0% -- 2790.3* -- 3.02 10.0% -- 3007.6* -- 3.25 *Mean DPM value for the group was according to the ANOVA (Dunnett-test) significantly higher than corresponding control value. The p value for the analysis was < 0.001.

Any other information on results incl. tables

Viability / Mortality: No deaths occurred during the study period.

Clinical Signs: No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period.

Body Weights: The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be a skin sensitiser in the LLNA when tested at 0.03, 0.3, 1.0, 3.0 and 10.0% in DMSO (w/v).
An EC3 value is calculated to be 3.0% (w/v).