Registration Dossier

Administrative data

Description of key information

Skin irritation:

No data available for p-TSH.

No specific data on OBSH is available. However, a classification for skin irritation for the substance is used for years as seen from more than 190 CLP notifiers to ECHA. If a minor degree of hydrolysis would occur on the humid skin this would result in release of corrosive substances (hydrazine and toluene-4-sulphonic acid). However, severe or corrosive irritational effects cannot be expected as this would have influenced on the acute toxicity potential by oral and inhalational exposure for OBSH. Thus, it is considered relevant to classify p-TSH as a skin irritant as well.

Eye irritation:

No data available for p-TSH

No specific data on OBSH is available. However, a classification for eye irritation for the substance is used for years as seen from as seen from more than 190 CLP notifiers to ECHA. If a minor degree of hydrolysis would occur on the humid environment of the eye this would result in release of corrosive substances (hydrazine and toluene-4-sulphonic acid). However, severe or corrosive irritational effects cannot be expected as this would have influenced on the acute toxicity potential by oral and inhalational exposure for OBSH. Thus, it is considered relevant to classify p-TSH as an eye irritant as well.

For further read-across justification see document attached in section 13.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Justification for type of information:
No reliable experimental data available on target substance. However, the read-across source substance OBSH (S1) in general is considered as an eye irritant as 131 notifiers out of 225 notifiers in the ECHA CLP database have classified the substance as skin irrit. 2. Due to the close chemical similarity to Toluene-4-sulphonohydrazide this is considered relevant for this substance as well. For full scientific clarification of Toluene-4-sulphonohydrazide this would warrant an in vivo testing. As the target substance will have to be classified as an skin irritant it is considered appropriate to classify the substance as skin irrit.2 here without further testing.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Justification for type of information:
No reliable experimental data available on the target substance. However, the read-across source substance OBSH (S1) in general is considered as an eye irritant as 133 notifiers out of 225 notifiers in the ECHA CLP database have classified the substance as eye irrit. 2. Due to the close chemical similarity to Toluene-4-sulphonohydrazide this is considered relevant for this substance as well. For full scientific clarification of Toluene-4-sulphonohydrazide this would warrant an in vivo testing. As the target substance will have to be classified as an eye irritant it is considered appropriate to classify the substance as eye irrit.2 here without further testing.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No reliable experimental data available. However, a classification for skin and eye irritation (skin irrit. 2 and eye irrit.2) for the substance is used for years as seen from as seen from more than 190 CLP notifiers to ECHA. For full scientific clarification this would warrant further in vivo testing for both endpoints. As the substance 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 substance is used for years as seen from as seen from more than 190 CLP notifiers to ECHA.

For full scientific clarification this would warrant an in vivo testing. As the substance will be classified as a skin sensitizer which indicate a potential for local activity it is considerde 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 substance is used for years as seen from as seen from more than 190 CLP notifiers to ECHA.

For full scientific clarification this would warrant an in vivo testing. As the substance will have to be classified as a skin irritant it is considerde appropriate to classify the substance as eye irrit.2 without further testing.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

No reliable experimental data available.

Based on the overall use of classification for skin and eye irritation by the majority of notifiers for OBSH (S1) the classification as Skin irrit. 2; H315 and Eye irrit.2; H319 is also maintained for the target substance p-TSH (T).

For further read-across justification see document attached in section 13.