Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July, 2016 to October, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Vinyltoluene
EC Number:
246-562-2
EC Name:
Vinyltoluene
Cas Number:
25013-15-4
Molecular formula:
C9H10
IUPAC Name:
Ethenylmethylbenzene
Test material form:
liquid

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

Positive control results:
No positive control group available.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: not applicable
Hours after challenge:
0
Group:
positive control
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not applicable
Remarks on result:
not measured/tested
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
Remarks on result:
no indication of skin sensitisation
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:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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 test substance 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).