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
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted July 22nd, 2010
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted May 30th, 2008
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:
- Name of test material (as cited in study report): Lucirin TPO
- Physical state: yellowish solid
- Analytical purity: 99.5% (w/w), BASF study code 11L00292
- Purity test date: 2011-09-08
- Lot/batch No.: 110053
- Expiration date of the lot/batch: July 19, 2015
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Pretest: Charles River, UK; Main Experiment: Harlan Lab. B.V., Netherlands
- Age at study initiation: Pretest: 9-10 weeks, main experiment: 8-9 weeks
- Weight at study initiation: 18.6 - 22.5g
- Housing: groups in makrolon type II or III cages
- Diet (e.g. ad libitum): pelleted standard diet ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2°C
- Humidity (%): 31-65%
- Photoperiod (hrs dark / hrs light): 12h/12h

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10%, 25%, 50% (w/w) (verified analytically)
No. of animals per dose:
5 (2 in the range finding test)
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: maximal achieveable concentration: 50%
- Irritation: 50%: erythema grade 1, slight ear swelling and an increase in ear thickness (33.3%), which was not observed anymore on day 6
25%: No signs of irritation or systemic toxicity were observed

MAIN STUDY
- Criteria used to consider a positive response:
1. at least one concentration of the test item, showing no excessive local irritation, results in an incorporation of ³HTdR ad least 3-fold greater than that recorded in control mice (indicated by the SI)
2. data are compatible with a conventional dose reponse, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
Sonicating and warming to 37°C was used for formulate the test item. Preparations were freshly made before dosing.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
2.22
Test group / Remarks:
10%
Parameter:
SI
Value:
2.96
Test group / Remarks:
25%
Parameter:
SI
Value:
3.45
Test group / Remarks:
50%
Parameter:
EC3
Value:
792.1
Parameter:
other: Disintegrations per minute
Value:
792.1
Test group / Remarks:
Control
Parameter:
other: Disintegrations per minute
Value:
1 757.5
Test group / Remarks:
10%
Parameter:
other: Disintegrations per minute
Value:
2 347.1
Test group / Remarks:
25%
Parameter:
other: Disintegrations per minute
Value:
2 742.3
Test group / Remarks:
50%

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test substance was found to be a sensitizer, the EC3 value was calculated to be 27%.