Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-180-0 | CAS number: 104-15-4
Endpoint summary
Administrative data
Description of key information
The ASA Category comprises the following 5 aromatic sulphonic acids:
TSA, Toluene-4-sulphonic acid (EC 203-180-0, CAS 104-15-4)
XSA, (Xylenes and 4-ethylbenzene) sulphonic acid (EC 701-247-3, CAS -) Former EC 246-839-8
CSA, p-cumene sulphonic acid (EC 240-210-1, CAS 16066-35-6)
BSA, Benzene sulphonic acid (EC 202-638-7, CAS 98-11-3)
HBSA, 4-hydroxybenzensulphonic acid (EC No. 202-691-6, CAS No. 98-67-9)
The skin sensitisation potential was assessed with available test on ASA and related salt (Hydrotropes substances). There is a single, key study for sensitization of the aromatic sulphonic acids performed on TSA. None of the tested animals showed positive responses in a, well documented, GLP guinea pig sensitization study (Hoechst, 1988). The test substance can be considered a non-sensitizer in guinea pigs as none of the test animals showed a positive response to combined intradermal and topical induction followed by topical challenge. The test on TSA was used in read across for XSA due to the chemical similarity between the two substances.
Further supporting information of the sensitising potential can be derived by the analogous category of Hydrotropes, for which some members (Cumene and Toluene derivatives) have been tested always with negative results. The test on cumene sulphonate was used in read across for CSA and the test on STS is used to support the absence of sensitization effects of TSA.
Based on the chemical similarity among ASA and Hydrotropes substances it is reasonable to consider the substances of this two categories as not skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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.
- 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.
Reference
See attached tables for details.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
There is no human or animal evidence of skin sensitization effects therefore no classification is requested based on Regulation (CE) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
