Registration Dossier
Registration Dossier
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EC number: 216-407-3 | CAS number: 1576-35-8
Endpoint summary
Administrative data
Description of key information
Skin irritation:
No reliable experimental data is available for Toluene-4-sulphonohydrazide (TSH). However, the presumed breakdown product toluene-4-sulphonic acid (CAS No. 104-15-4) has a harmonized classification for Skin Irrit. 2, H315. Furthermore, toluene-4-sulphonic acid is considered as skin corrosive since > 500 notifiers in the ECHA CLP database have classified the substance as Skin Corr. 1C. Likewise, hydrazine (CAS No. 302-01-2), another presumed breakdown product of Toluene-4-sulphonohydrazid, has a harmonized classification for Skin Corr. 1B. Based on the skin irritation and corrosiveness of the breakdown products it is considered appropriate to classify the substance as skin irrit.2 here without further testing.
Eye irritation:
No reliable experimental data is available for Toluene-4-sulphonohydrazide (TSH). However, the presumed breakdown product toluene-4-sulphonic acid (CAS No. 104-15-4) has a harmonized classification for Eye Irrit. 2, H319. Furthermore, toluene-4-sulphonic acid is considered to be able to induce sever eye damage since 593 notifiers in the ECHA CLP database have classified the substance as Eye Dam.1. Likewise, hydrazine (CAS No. 302-01-2), another breakdown product of Toluene-4-sulphonohydrazid, is considered to be able to induce severe eye damage since 596 notifiers in the ECHA CLP database have classified the substance as Eye Dam.1. Based on the effect to the eyes of the breakdown products it is considered appropriate to classify the substance as Eye Irrit. 2 here without further testing.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- No testing data on skin irriation is available for Toluene-4-sulphonohydrazide (TSH).
Use of Danish QSAR database and ToxTree; and classification of two pressumed breakdown products - Principles of method if other than guideline:
- in silico prediction models
- Danish QSAR database
- ToxTree (v3.1.0-1851-1525442531402) - Irritation parameter:
- other: QSAR prediciton
- Remarks on result:
- other: QSAR predicitons considered equivocal
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- it is considered appropriate to classify the substance as skin irrit.2
- Executive summary:
No testing data on skin irritation is available for Toluene-4-sulphonohydrazide (TSH).
From QSAR predictions on skin irritation using the Danish QSAR database (see attached prediction report), only one out of three separate predictions from CASE Ultra, Leadscope and SciQSAR was considered valid (i.e., SciQSAR: Negative_ in scope). The leadscope had a positive prediction for skin irritation (out of scope) and the CASEultra had an inconclusive prediction for skin irritation. The overall prediction results for skin irritation are equivocal. Using the Toxtree programme, no alerts were identified for skin irritation.
Based on the overall dataset from different in silico prediction models (Danish QSAR database and ToxTree) no valid conclusion can be derived for skin irritation of TSH.
However, data from the presumed breakdown products of TSH can be used for the evaluation of the skin irritative potential of TSH. When applied to skin, TSH is expected to slowly hydrolyse due to the moisture in the skin with the presumed products being toluene-4-sulphonic acid (CAS No. 104-15-4) and hydrazine (CAS No. 302-01-2). This hydrolysis is though evaluated to be slow indicating that the concentration of the breakdown products also is low.
Toluene-4-sulphonic acid (CAS No. 104-15-4) has a harmonized classification for Skin Irrit. 2, H315. Furthermore, toluene-4-sulphonic acid is considered as skin corrosive since > 500 notifiers in the ECHA CLP database have classified the substance as Skin Corr. 1C.
Hydrazine (CAS No. 302-01-2) may be generated and could induce skin damage. Hydrazine, has a harmonized classification for Skin Corr. 1B.
Based on the skin irritation and corrosiveness of the two presumed breakdown products it is considered appropriate as a precautionary approach to classify TSH as skin irrit.2 here without further testing.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No reliable experimental data available for Toluene-4-sulphonohydrazide (TSH). However, a classification for skin and eye irritation (skin irrit. 2 and eye irrit.2) for the presumed breakdown products of TSH has been used for years as seen from the CLP notifiers to ECHA CLP database. For full scientific clarification this would warrant further in vivo testing for both endpoints. As TSH will be classified as a skin sensitizer which indicate a potential for local activity it is considered appropriate to classify the substance as skin irrit.2 and eye irrit.2 without further testing.
Justification for selection of skin irritation / corrosion endpoint:
No reliable experimental data available.
However, a classification for skin and eye irritation (skin irrit. 2 and eye irrit.2) for the presumed breakdown products has been used for years as seen from CLP notifications to the ECHA CLP database.
For full scientific clarification this would warrant an in vivo testing. As TSH will be classified as a skin sensitizer which indicate a potential for local activity it is considered appropriate to classify the substance as skin irrit.2 without further testing.
Justification for selection of eye irritation endpoint:
No reliable experimental data available.
However, a classification for skin and eye irritation (skin irrit. 2 and eye irrit.2) for the presumed breakdown products has been used for years as seen from CLP notifications to the ECHA CLP database.
For full scientific clarification this would warrant an in vivo testing. As TSH will be classified as a skin sensitizer which indicate a potential for local activity it is considered appropriate to classify the substance the substance as eye irrit.2 without further testing. Further, TSH is also classified as skin irrit.2.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
No reliable experimental data available for Toluene-4-sulphonohydrazide (TSH).
Based on the overall use of classification for skin and eye irritation by the majority of notifiers for the presumed breakdown products of TSH, the classification as Skin irrit. 2; H315 and Eye irrit.2; H319 is concluded.
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