Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc
- Test material form:
- liquid - solid: mixture of
- Remarks:
- water and Reaction products of 2-hydroxybenzoic acid and styrene and zinc oxide
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Induction
- 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
Challenge
- 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
Results and discussion
- Positive control results:
- Erythema and oedema was observed in every animal of positive control group, and the sensitisation rate was 100%.
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
There were no erythema, oedema and other skin changed observed in treated and negative control groups after two induction and one challenge exposures.
Applicant's summary and conclusion
- 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.
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