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EC number: 203-180-0 | CAS number: 104-15-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1.11.1988-9.12.1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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
- Principles of method if other than guideline:
- Acceptable method
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was already existing
Test material
- Reference substance name:
- p-toluenesulfonic acid
- IUPAC Name:
- p-toluenesulfonic acid
- Reference substance name:
- Toluene-4-sulphonic acid
- EC Number:
- 203-180-0
- EC Name:
- Toluene-4-sulphonic acid
- Cas Number:
- 104-15-4
- Molecular formula:
- C7H8O3S
- IUPAC Name:
- 4-methylbenzene-1-sulfonic acid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- female
- Details on test animals and environmental conditions:
- Supplier: Hoechst AG, Kastengrund, SPF-Zucht
Weight: 310-394 g
Housing: Makrolon cages (type 4), Weichholz-granulate bedding, 5 animals per cage, air conditioned system
Temperature: 22 ± 3 °C
Relative Humidity: 50 ± 20 %
Phot period: 12h/12h
Food: ad libitum feed for animals (Supplier: ERKA- Mishfutter Nr. 8300)
Water: ad libitum, tap water
Acclimation: 5 days
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.2 %
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 %
- Adequacy of challenge:
- not specified
- 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
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- 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.
Any other information on results incl. tables
See attached tables for details.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin sensitizer
- Executive summary:
The skin sensitization potential of Toluene 4-sulphonic acid was assessed following official EU Method B.6, Skin sensitization. None of the tested animals showed positive responses and the test substance can be considered a non-sensitizer in guinea pigs.
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