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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
July, 2016 to October, 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Reda across study
Justification for type of information:
The study with the read across substance is considered sufficient to fulfil the information requirements.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A guinea pig maximisation study was conducted as the most approriate test method for the test substance.
Species:
guinea pig
Strain:
other: BFA (Albino)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lubos Sobota, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Adults
- Housing: in cages on soft wood shavings
- Diet (e.g. ad libitum): Altromin Spezialfutter GmbH
- Water (e.g. ad libitum): Yes
- Acclimation period: min 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: To:25.7 - 26.8.2016
Route:
intradermal
Vehicle:
other: Freund's Complete Adjuvant:Saline (1:1; v/v)
Concentration / amount:
0.1 ml
Day(s)/duration:
Single injection on Day 0
Adequacy of induction:
other: Treated group
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
0.1 ml, 20% test substance in olive oil
Day(s)/duration:
Single injection on Day 0
Adequacy of induction:
other: Treated group
Route:
intradermal
Vehicle:
other: Freund's Complete Adjuvant: Saline (1:1, v/v)
Concentration / amount:
0.1 ml, 20% test substance in FCA:Saline (1:1)
Day(s)/duration:
Single injection on Day 0
Adequacy of induction:
other: Treated group
Route:
intradermal
Vehicle:
other: Freund's Complete Adjuvant: Saline (1:1, v/v)
Concentration / amount:
0.1 ml
Day(s)/duration:
Single injection on Day 0
Adequacy of induction:
other: Control group
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
0.1 ml
Day(s)/duration:
Single injection on Day 0
Adequacy of induction:
other: Control group
Route:
intradermal
Vehicle:
other: 50% formulation of Freund's Complete Adjuvant:saline (1:1, v/v)
Concentration / amount:
0.1 ml
Day(s)/duration:
Sngle injection on Day 0
Adequacy of induction:
other: Control group
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test substance
Day(s)/duration:
48 h application on shaved skin on Day 6
Adequacy of induction:
other: Treated Group
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
100%
Day(s)/duration:
48 h application on shaved skin on Day 6
Adequacy of induction:
other: Control group
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
70% test substance in olive oil
Day(s)/duration:
24 h application on shaved skin on Day 20, right flank of all animals
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
100% olive oil
Day(s)/duration:
24 h application on shaved skin on Day 20, left flank of all animals
No. of animals per dose:
Treated group: 20 animals (11 males and 9 females)
Control group; 10 animals (6 males and 4 females)
Details on study design:
Obervation of skin reactions on Days 22-23 at 48 h from the challenge application, then again 24 h later (72 h from challenge application)
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20% test substance in olive oil (induction), 70% test substance in olive oil (challenge)
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
One animal with discrete or patchy erythema
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
20% test substance in olive oil (induction), 70% test substance in olive oil (challenge)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None

The bodyweights of the animals in the treated groups did not differ significantly from those of the control group throughout the study.

Treated animals did not show any clinical symptoms of intoxication.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the Magnusson and Kligman Guinea pig maximisation study, the test substance was not considered to be sensitising.
Executive summary:

A study was conducted to determine the skin sensitisation potential of the read across substance, vinyl toluene, according to EU Method B6 (Magnusson and Kligman maximisation test), in compliance with GLP. A pilot experiment was implemented on 3 animals. The main study was performed on 20 treated and 10 control animals (males and females). The experiment proceeded in 3 phases: two induction phases (intradermal injections and topical occlusive application) and the challenge phase. Potential skin reactions were evaluated at the end of the experiment. The evaluation of skin reactions in the treated group carried out 48 h after the start of the challenge phase showed discrete erythema in 1 of 20 animals (5%) in the left flank exposed to the test substance. No other negative clinical symptoms were recorded throughout the experiment. Under the conditions of the Magnusson and Kligman Guinea pig maximisation study, the test substance was not considered to be sensitising (Chudobová, 2016).

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

A study was conducted to determine the skin sensitisation potential of the read across substance, vinyl toluene, according to EU Method B6 (Magnusson and Kligman maximisation test), in compliance with GLP. A pilot experiment was implemented on 3 animals. The main study was performed on 20 treated and 10 control animals (males and females). The experiment proceeded in 3 phases: two induction phases (intradermal injections and topical occlusive application) and the challenge phase. Potential skin reactions were evaluated at the end of the experiment. The evaluation of skin reactions in the treated group carried out 48 h after the start of the challenge phase showed discrete erythema in 1 of 20 animals (5%) in the left flank exposed to the test substance. No other negative clinical symptoms were recorded throughout the experiment. Under the conditions of the Magnusson and Kligman Guinea pig maximisation study, the test substance was not considered to be sensitising (Chudobová, 2016).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the in vivo study with the read-across substance, vinyl toluene, the test substance does not warrant classification according to EU CLP (1272/2008) criteria.