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EC number: 810-688-1 | CAS number: 14034-59-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions in design and/or reporting buth otherwise adequate for assessment
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:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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
- IUPAC Name:
- 4-methylbenzenesulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): p-Toluolsulfonsäure
- Physical state: grayish white crystalline product
- Purity: >98%
- Storage: in the dark at room temperature, with LEV
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
- Weight at study initiation: mean 351 g (310-394 g)
- Housing: 5 animals per cage, in Makrolon Type 4 cages, on softwood granules
- Diet: ad libitum, ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Concentration / amount:
- - Intradermal induction: 0.2%
- Epicutaneous induction: 20%
- Challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- 0.9%
- Concentration / amount:
- - Intradermal induction: 0.2%
- Epicutaneous induction: 20%
- Challenge: 10%
- No. of animals per dose:
- - Test material: 10
- Control: 5 - Details on study design:
- RANGE FINDING TESTS:
A. EPICUTANEOUS EXPOSURE
- Amount applied: 0.5 mL of the test substance formulation was applied to 2 x 2 cm filter paper strips. This was applied to the skin of the flanks under an occlusive dressing and fixated.
- Concentrations tested: 0.01, 0.1, 1, 5, 10 and 20% dissolved in 0.9% physiological saline
- Exposure period: 24 hours
- Site of application: flank
- Number of test animals: 7 (multiple concentrations tested in the same animal)
- Readings: 24 after the beginning of application
B. INTRADERMAL INDUCTION
To determine the intradermal compatibility the test substance the following preparations were injected in three guinea pigs in groups of two, in a 2 x 4 cm area: 1) 0.1 mL of 0.2% test substance in 0.9% physiological saline, 2) 0.1 mL of 0.04% test substance in 0.9% physiological saline, 3) 0.1 mL of 0.008% test substance in 0.9% physiological saline.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (day 1 intradermal injections + day 9 epicutaneous exposure)
- A total of six intradermal injections in groups of two per animal was made, in a 2 x 4 cm area. These injections were: 1) front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1, 2) middle row: 2 injections each of 0.1 mL of the test substance formulation, 3) back row: 2 injections each of 0.1 mL Freund's adjuvant/ 0.9% aqueous NaCl-solution (1:1) with test substance.
- Epicutaneous exposure: 0.5 mL of the test substance was applied to a 2 x 4 cm filter paper strip, which applied to the skin of the shoulder under an occlusive dressing (impermeable film and elastic adhesive bandage).
- Exposure period (epicutaneous): 48 hours
- Control group: The animals were given the same injections (1,2,3) but without test substance, only with the formulating agent. For epicutaneous exposure the control groups received the vehicle only.
- Site: shoulder
- Evaluation: from day 1 till day 8, and after removal of the occlusive epicutanous exposure (48 hours after start of this exposure)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure: 0.5 mL of the test substance was applied to a 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing (impermeable film elastic adhesive bandage).
- Day(s) of challenge: at day 22
- Exposure period: 24 h
- Site: intact left flank
- Evaluation (hr after challenge): 24 and 48 after the removal of the patch - Challenge controls:
- The control animals received in the induction exposure the same injections (1,2,3) but without test substance, only with the formulating agent. For epicutaneous exposure the control groups received the vehicle only. With the challenge exposure the control animals received the same exposure as animals from the test group (0.5 mL of 10% test substance in 0.9% physiol. saline).
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- 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: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- 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: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd 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: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RANGE FINDING TESTS
- EPICUTANEOUS EXPOSURE: After treatment with the 20% concentration one animal showed erythema, but a barely perceptible edema. In the other animal very slight edema was observed. At the other tested concentrations no signs of irritation were observed.
- INTRADERMAL INDUCTION: The injection of 0.2% of the test substance resulted in edema, but no erythema. No effects were observed with the other tested concentrations.
MAIN TEST
The intradermal injections with Freund’s adjuvant, with and without test substance, resulted in severe redness and swelling which lasted for one day. In some cases formation of crusts were observed. After removal of the occlusive dressing (day 11) necrosis and scars were observed on these parts of the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item p-Toluolsulfonsäure is not considered to be a skin sensitizer under the test conditions of this study.
- Executive summary:
In a GLP complaint sensitivity study using the Maximization-Test, performed according to OECD guideline 406, Pirbright-Hartley guinea pigs were treated with the test substance. Ten animals were treated with the test substance and five with only the vehicle (physiological saline). The concentrations of the test substance used in the main study were determined by the results of the preliminary study. The intradermal induction of sensitization in the test group was performed using 0.2% of the test substance in both the vehicle and the Freund's Complete Adjuvant/vehicle mixture. Eight days later this was boosted by the topical application of the test substance at 20% concentration over the injections sites. Animals of the control group were treated in the same manner but the selected vehicle was used. Two weeks after the second induction all animals were challenged by topical application of the test substance at 10% concentration. The animals in the test groups showed no response (after 24 and 48 hours). Therefore it can be concluded that the test substance shows no skin sensitizing potential in guinea pigs.
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