Registration Dossier
Registration Dossier
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EC number: 203-197-3 | CAS number: 104-38-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The study used the footpad method, as mentioned in the OECD 406 guidelines (1981)
- GLP compliance:
- no
- Remarks:
- However was subject to Quality Assurance
- Type of study:
- other: Foodpad method
- Justification for non-LLNA method:
- Study available from 1989, LLNA method not yet accepted guideline
Test material
- Reference substance name:
- 2,2'-p-phenylenedioxydiethanol
- EC Number:
- 203-197-3
- EC Name:
- 2,2'-p-phenylenedioxydiethanol
- Cas Number:
- 104-38-1
- Molecular formula:
- C10H14O4
- IUPAC Name:
- 2,2'-[1,4-phenylenebis(oxy)]diethanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Cr1:(HA)BR Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Acetone/dioxane/guinea pig fat
- Concentration / amount:
- Induction: 1% w/v
Challenge: 10% w/v
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Acetone/dioxane/guinea pig fat
- Concentration / amount:
- Induction: 1% w/v
Challenge: 10% w/v
- No. of animals per dose:
- 10 females
- Challenge controls:
- 10 females
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
No reaction was observed at challenge in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria (Reg 1272/2008) are not met
- Conclusions:
- HQEE was not a skin sensitiser in this assay
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