Registration Dossier
Registration Dossier
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EC number: 212-550-0 | CAS number: 825-90-1
Endpoint summary
Administrative data
Description of key information
An attempt was made to predict the skin sensitisation potential of sodium 4 -hydroxybenzenesulfonate using the OECD Toolbox v 4.4.1. In first step, the profiling schemes related to the skin sensitisation were run. In the second step, the auomated workflow for skin sensitisation for GPMT was run. All the alerts related to skin sensitisation came out negative. Also the automated workflow predicted the substance to be negative in the Guinea pig maximisation test using read across. Toluene-4 sulfonic acid was tested for skin sensitisation potential in a guinea pig maximisation test conducted according to OECD Guideline 406. In this study 10 females in test group and 5 females in control group were used. For induction exposure the flanks (both sides) were exposed along the midline. The intradermal injection (0.1 mL of 0.2 % test substance) was done on day1 followed by topical application (20 % solution) on day 9 (48 hours duration). The challenge exposure was done on day 22 (24 hr exposure) on left flank with 10 % test substance in saline solution. The post-challenge evaluation was done at 48 hours and 72 hours. None of the tested animals showed positive responses. The test substance can be considered a non-sensitizer in guinea pigs. As a conclusion, S4HBS can be considered to be a non-sensitiser to the skin. Currently another set of in vitro studies is under investigation to further evaluate the sensitisation potential of the test item. Once the results are available these will be communicated with an additional dossier update and the waiver for the in vitro skin sensitisation study will be removed.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 13 January, 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
: OECD Toolbox
2. MODEL (incl. version number) : 4.4.1
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL : CAS number 890-25-1 was used.
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
The QMRF is attached in the section 13 with the title "Prediction of Skin sensitisation for Benzenesulfonic acid, 4-hydroxy-, monosodium salt".
5. APPLICABILITY DOMAIN
The substance was within the applicability domain. For more details, please refer to the QMRF attached in the section 13 with the title "Prediction of Skin sensitisation for Benzenesulfonic acid, 4-hydroxy-, monosodium salt".
6. ADEQUACY OF THE RESULT
The prediction supports the conclusion that the substance is not a skin sensitiser and thus no classification is required. - Qualifier:
- according to guideline
- Guideline:
- other: REACH guidance on QSARs R.6. May/July 2006
- GLP compliance:
- no
- Remarks:
- QSAR, hence not applicable
- Species:
- guinea pig
- Key result
- Reading:
- other: Skin sensitisation
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sodium 4-hydroxybenzenesulfonate was predicted to be not a skin sensitiser.
- Executive summary:
An attempt was made to predict the skin sensitisation potential of sodium 4 -hydroxybenzenesulfonate using the OECD Toolbox v 4.4.1. In first step, the profiling schemes related to the skin sensitisation were run. In the second step, the auomated workflow for skin sensitisation for GPMT was run. All the alerts related to skin sensitisation came out negative. Also the automated workflow predicted the substance to be negative in the Guinea pig maximisation test using read-across.
Reference
All the alerts related to skin sensitisation came out negative. Also the automated workflow predicted the substance to be negative in the Guinea pig maximisation test using read across.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
As the substance was not considered to be a sensitiser, it does not warrant classification as per Regulation EC No. 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.
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