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Diss Factsheets

Administrative data

Description of key information

Skin sensatisation: Negative(OECD 406)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
non-LLNA method already available.
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Center of Experimental Animals,AMS, Beijing
- Weight at study initiation: 250-300 g
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 °C
- Humidity (%): 60-70%
- Photoperiod (hrs dark / hrs light): 12 hour of light and 12 hour of dark
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Three pairs of intradermal injection of 0.1 mL were given in the test area. The component and concentration of the test subtance were given as below:



Day 0 indution:Intradermal injections
Injection 1: a 1:1 mixture (v/v) FCA/Physiological saline
Injection 2: 25%(v/v) of test substance in the Physiological saline
Injection 3: 25%(v/v) of the test substance in the 1:1 mixture (v/v) of the FCA/Physiological saline

Day 6 Induction: topical application

Because the substance is not a skin irritant, 0.5 mL of 10% sodium lauryl sulphate in Vaseline was painted on the again clipped test area in order to creat a local irritation.
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
12.5% v/v test substance in physiological saline( 0.2 mL)
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene
Positive control results:
Erythema and oedema was observed in every animal of positive control group, and the sensitisation rate was 100%.
Reading:
1st reading
Hours after challenge:
27
Group:
positive control
Dose level:
2.5 mg/g
No. with + reactions:
10
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
27
Group:
negative control
Dose level:
0.9%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
27
Group:
test chemical
Dose level:
12.5% v/v
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
3
Group:
test chemical
Dose level:
12.5% v/v
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
27
Group:
test chemical
Dose level:
12.5% v/v
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
3
Group:
test chemical
Dose level:
12.5% v/v
No. with + reactions:
0
Total no. in group:
10

There were no erythema, oedema and other skin changed observed in treated and negative control groups after two induction and one challenge exposures.

Interpretation of results:
GHS criteria not met
Conclusions:
According to the study, the test item was considered as non-sensitisation.
Executive summary:

In the skin sensitization study according to TG OECD 406, 40 male adult puinea pigs were applied with  test material(10 animals/group), positive control substance(10 animals/group) and negative control substance(10 animals/group) . There were no erythema, oedema and other skin changed observed in treated and negative control groups after two induction and one challenge exposures. The sensitisation rate was 0%. Under the above test conditions, the substance was considered as not sensitisation.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In the skin sensitization study according to TG OECD 406, 20 male adult puinea pigs were applied with  Reaction Product of 2-Hydroxybenzoic Acid, Styrene and Oxozinc. There were no erythema, oedema or other skin changed observed in treated  group after two induction and one challenge exposures. The sensitisation rate was 0%. Under the above test conditions, the substance was considered as not sensitisation.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc does not need to be classified for skin sensitisation when considering the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC) and Annex I of Regulation 286/2011/EC.