Registration Dossier
Registration Dossier
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EC number: 202-691-6 | CAS number: 98-67-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1988, prior to LLNA being the gold standard for sensitization testing. With regard to the good quality of the study, there is no scientific justification for the conduct of another sensitization study.
Test material
- 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-methylbenzenesulfonic acid
- Details on test material:
- - product number: GPAD 185
- CAS number: 104-15-4
- appearance: grey to white, cristalline powder
- MW: 190.2 g/mol
- melting point: 98 °C
- decomposition temperature: approx. 170 °C
- solubility: readily in water
- pH in water: below 1
- imurities: 0.3% H2SO4
- purity: > 98 %
- storage: in the dark at room temperature under local exhaust ventilation
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- strain: Hoe: DHPK(SPFLac)
- Weight at study initiation: approx. 351 g
- Housing: in groups (5 animals)
- Diet (e.g. ad libitum): ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits, ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Treatment group:
- intradermal induction: 0.2% in 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 20% in 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline
Control group:
- intradermal induction: 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Treatment group:
- intradermal induction: 0.2% in 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 20% in 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline
Control group:
- intradermal induction: 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline
- No. of animals per dose:
- 10 (treatment) and 5 (control)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: control group
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: control group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
No signs of irritation after epidermal application of the test substance were noted using the 0.01%; 0.1%; 1%; 5%; and 10% concentrations, with and without Freud Adjuvant.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
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