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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jun 06 2000 - Jun 30 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo assay OECD 406 was performed before the OECD 429 assay was mandatory.

Test material

Constituent 1
Chemical structure
Reference substance name:
(trans(trans))-4'-vinyl-4-(4-methylphenyl)bicyclohexyl
EC Number:
439-730-3
EC Name:
(trans(trans))-4'-vinyl-4-(4-methylphenyl)bicyclohexyl
Cas Number:
155041-85-3
Molecular formula:
Hill formula: C21H30 CAS formula: C21H30
IUPAC Name:
(trans(trans))-4'-Vinyl-4-(4-methylphenyl)bicyclohexyl

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPoc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: about 6 weeks (beginning of treatment)
- Weight at study initiation: 372 g (range from 316 g to 415 g)
- Housing: single Makrolon cage type with a shelter placed on mobile racksbedding conventional softwood granulate bedding change twice weekly
- Diet: ad libitum; exclusive diet for guinea pigs No. 845, Eberle Nafag
- Water: ad libitum; community tap water from Makrolon drinking bottles
- Acclimation period: At least 7 days prior to the start of dosing under test conditions after health examination. The guinea pigs were identified by color mark.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 27 °C
- Humidity: 46 - 84 %
- Air changes (per hr): not specified
- Photoperiod: 12 hours light / 12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
5 g/L
Day(s)/duration:
on Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
50 g/L
Day(s)/duration:
on Day 8/ 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
10 g/L
Day(s)/duration:
on Day 22/24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Total: 35 females
Pre-test: 5 females
Control group: 10 females (negative control)
Test group 20 females (test material)
Details on study design:
RANGE FINDING TESTS:
- intradermal injection: 0, 1, 5, 10, 25, 50 g/L given to one animal
- topical applications, no pretreatment: 1, 10, 50, 100, 200, 400 g/L given to four animals
- topical applications, pretreatment with FCA: 1, 5, 10, 25 g/L given to two animals

MAIN STUDY

A1.
INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: 6 injections of 0.1 mL each, three on each side of the spinal column)
- Test groups: 0.1 mL FCA + NaCl, 5g/L test item ad liquid paraffin, FCA + 5 g/L test item + NaCl
- Control group: 0.1 mL FCA + NaCl, 0.1 mL liquid paraffin, 0.1 mL FCA + NaCl
- Site: cranial, medial, caudal- Frequency of applications: single
- Concentrations: 5 g/L

A2.
INDUCTION EXPOSURE (topical application)
- No. of exposures: one week after injection (A1) single topical application of a filter plate soaked with either test solution, or vehicle
- Test groups: Test item (50 g/L) in liquid paraffin
- Control group: liquid paraffin- Site: cranial, medial, caudal (8 cm^2)
- Frequency of applications: single
- Duration: 48 h, occlusive
- Concentrations: 50 g/LB.

CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
- Test groups: 10 g/L test item
- Control group: liquid paraffin
- Site: cranial, medial, caudal (4 cm^2)
- Concentrations: 10 g/L
- Evaluation (hr after challenge): 48 and 72 h
Challenge controls:
Data from the GLP study. Experimental part: April 11 until May 05, 2000.
Positive control substance(s):
yes
Remarks:
Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
7
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
4
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the given experimental conditions, the test material induced no reactions. According to the Regulation (EC) No 1272/2008, the test material is not to be classified as a skin sensitizer.
Executive summary:

The purpose of this assay was to identify the contact allergenic potential of the test item in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man. The test item as investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 10 females were treated with the vehicles liquid paraffin (group 1) and 20 females were treated with the test material (group 2). The induction included intradermal injection of test material preparation in liquid paraffin (5 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in liquid paraffine (50 g/L) for 48 hours on experimental day 8. The challenge was performed by topical application of the test material preparation (10 g/L) for 24 hours, two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment. After challenge no positive reactions were seen 48 or 72 hours after treatment with the test material. Under the given experimental conditions, the test material induced no reactions. Therefore, the test material is not considered to be a skin sensitizer.

It should be noted that this study was already evaluated by the German competent authority BAUA during the registration under ChemG. BAUA agreed with the scientific interpretation of the results presented here.