Registration Dossier
Registration Dossier
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EC number: 414-420-0 | CAS number: - SPE 93279
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (maximisation test)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed in 1992. LLNA method (OECD 442 B) was adopted in 2010 and also the (OECD tests n°442 C , D) was adopted in 2015.
Test material
- Reference substance name:
- A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside
- EC Number:
- 414-420-0
- EC Name:
- A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside
- Cas Number:
- 125590-73-0
- Molecular formula:
- (C6H10O5)n, C8H18O n = 1,2
- IUPAC Name:
- Reaction mass of 2-ethylhexyl mono-D-glucopyranoside and 2-ethylhexyl di-D-glucopyranoside
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- concentration of test material and vehicle used at induction:
intradermal: 0.5 % v/v in water for irrigation
topical: 50% v/v in distilled water
Concentration of test material and vehicle used for each challenge:
5% v/v in distilled water
10% v/v in distilled water
Challenge
- Concentration / amount:
- concentration of test material and vehicle used at induction:
intradermal: 0.5 % v/v in water for irrigation
topical: 50% v/v in distilled water
Concentration of test material and vehicle used for each challenge:
5% v/v in distilled water
10% v/v in distilled water
- No. of animals per dose:
- number of animals in test group: 30
number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 30
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 30
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 10%
Signs of irritation during induction: signs of slight irritation following intradermal injection and slight to moderate erythema after topical application.
Evidence of sensitization of each challenge concentration : 5%-0, 10%-6
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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