Registration Dossier
Registration Dossier
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EC number: 277-962-5 | CAS number: 74665-14-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: ead-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1.11.1988-9.12.1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A GLP study with good documentation but with fewer test animals than specified by guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- lower number of test animals
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Skin sensitization non-LLNA is not available because data on one constituent has been performed. In addition, skin sensitization test can be waived due to the corrosivity of the substance (pH < 2).
Test material
- Reference substance name:
- 4-toluene-sulphonic acid
- IUPAC Name:
- 4-toluene-sulphonic acid
- Details on test material:
- - Name of test material (as cited in study report): p-Toluolsulfonsaure
- Substance type: organic
- Physical state: solid
- Analytical purity: >98%
- Isomers composition: p-isomer:84.6%; o-isomer: 10.6%; m-isomer: 4.6%
- Lot/batch No.: GPAD 185
- Expiration date of the lot/batch: no data
- Storage condition of test material: in dark at 20C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 0.2%
topical induction: 20%
topical challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 0.2%
topical induction: 20%
topical challenge: 10%
- No. of animals per dose:
- 10 females in test group and 5 females in control group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in saline solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no positive response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no positive response.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% in saline solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no positive response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no positive response.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% in saline solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no positive response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no positive response.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10% in saline solution
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no positive response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no positive response.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- None of the tested animals showed positive responses. The test substance can be considered a non-sensitizer in guinea pigs.
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