Registration Dossier
Registration Dossier
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EC number: 216-629-0 | CAS number: 1630-78-0
Endpoint summary
Administrative data
Description of key information
Skin and eye irritation studies were not technically feasible to conduct on a gas substance.
An in-vitro skin irritation study cannot be conducted because the available in-vitro test methods are not applicable for a gas substance. In-vitro skin irritation tests (OECD 439) do not allow for testing of gases and are not validated for gases.
An in-vivo skin irritation study cannot be conducted because the available in-vivo test method (OECD 404) does not allow for testing of gaseous substances and there are no other validated test methods.
An in-vitro eye irritation study cannot be conducted because the available in-vitro test methods are not applicable for a gas substance. In-vitro eye irritation tests (OECD 437, 438, 492) do not allow for testing of gases and are not validated for gases.
An in-vivo eye irritation study cannot be conducted because the available in-vivo test method (OECD 405) does not allow for testing of gaseous substances and there are no other validated test methods.
As the substance is a gas, dermal irritation is not considered to be a relevant concern for the substance. In addition, the substance will be used mainly in closed systems where significant (dermal) exposure is not considered likely.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- An in-vitro skin irritation study cannot be conducted because the available in-vitro test methods are not applicable for a gas substance. In-vitro skin irritation tests (OECD 439) do not allow for testing of gases and are not validated for gases.
- Endpoint:
- skin irritation: in vivo
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Respiratoy irritation:
In acute and repeated dose toxicity tests by the inhalation route, there were no significant clinical signs of toxicity (including histopathology) associated with respiratory irritation.
Justification for classification or non-classification
Skin and eye irritation: In-vitro and in-vivo studies are not available as there are no validated test methods of gaseous substances. No relevant human data (such as epidemioligical and clinical studies) are available.
Respiratory irritation: Classification for respiratory tract irritation (STOT-SE 3, H335: May cause respiratory irritation) is primarily based on human data. No relevant human data is available. There are currently no validated animal tests the deal specifically with RTI but useful information can be obtained from inhalation toxicity tests. In acute and repeated dose inhalation toxicity studies, no significant clinical signs of toxicity and histopathology were observed that are characteristic of RTI. Therefore, the substance has not been classified for STOT-SE 3 (H335).
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