Registration Dossier
Registration Dossier
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EC number: 245-122-7 | CAS number: 22613-51-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- At the time of the study, it didn't use to perform LLNA method
Test material
- Reference substance name:
- 2-acetoxyethyl stearate
- EC Number:
- 245-122-7
- EC Name:
- 2-acetoxyethyl stearate
- Cas Number:
- 22613-51-0
- Molecular formula:
- C22H42O4
- IUPAC Name:
- 2-acetoxyethyl stearate
- Reference substance name:
- White mineral oil (petroleum)
- EC Number:
- 232-455-8
- EC Name:
- White mineral oil (petroleum)
- Cas Number:
- 8042-47-5
- Test material form:
- liquid: viscous
Constituent 1
additive 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 3% of AGS, 97% paraffin oil
- Day(s)/duration:
- Day 0: duration 24h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- other: washing with 10% SDS solution
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% SDS; 90% paraffin oil
- Day(s)/duration:
- Day 7: duration 24h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% AGS, 75% paraffin oil
- Day(s)/duration:
- Days 8 and 9: duration 48h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 3% AGS, 97% paraffin oil
- Day(s)/duration:
- Day 22: duration 24h
- Adequacy of challenge:
- not specified
- Route:
- epicutaneous, occlusive
- Day(s)/duration:
- Days 23-24: washing of the treated area and observation (24-48h)
- No. of animals per dose:
- 30 (20 tested animals, 10 control animals)
- Challenge controls:
- 10 Guinea pigs
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% of AGS in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% og AGS in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
There were no mortalities. There was no treatment related alteration of body weight increase. Any consistent evidence of treatment related kin irritation was absent. Any evidence of skin reaction attributable to a sensitizing activity of AGS was absent. In conclusion te result of this assay indicates that, in our experimental conditions, AGS is devoid of sensitizing activity in Guinea pig.
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