Registration Dossier

Administrative data

Description of key information

For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 406. Based on the results of the structural analogue substance, the test item is not considered to be sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 406.
See chapter 13 report for a more detailed justification.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs
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 clinical signs
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 clinical signs
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
Interpretation of results:
GHS criteria not met
Conclusions:
For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 406.
The source compound was negative in this in vivo assay. See chapter 13 report for a more detailed justification.
Endpoint:
skin sensitisation: in chemico
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. certificate)
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 information:
Composition 1
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 (e.g. ad libitum): exclusive diet for guinea pigs No. 845, Eberle Nafag
- Water (e.g. ad libitum):community tap water ad libitum 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 (°C): 21-27 °C- Humidity (%): 46-84 %
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
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
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
10 g/L
Day(s)/duration:
on Day 15/24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Total: 35 females
Pre-test: 5 femalesControl 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 STUDYA1.
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/LA2.

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
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
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 group
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
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:

Purpose

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.

Study Design

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.

Results

After challenge no positive reactions were seen 48 or 72 hours after treatment with the test material.

Conclusions

Under the given experimental conditions, the test material induced no reactions. Therefore, the test material is not considered to be a skin sensitizer according to Regulation (EC) No 1272/2008.

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the experimental data obtained from a structural analogue substance, the test item is not considered to be classified as skin sensitizer according to Regulation (EC) No 1272/2008.