Registration Dossier
Registration Dossier
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EC number: 807-789-8 | CAS number: 111062-42-1
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Annex VIII 8.5 indicates that in addition to the oral route, the information shall be provided for at least one other route (dermal or inhalation). The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The dermal route is the appropriate second route as inhalation is unlikely due to the vapour pressure of ≤ 0.0000858 Pa at 20 °C. Skin contact during use as a textile fiber lubricant/finish is likely and the absorption through the skin is anticipated to be identical to the oral or inhalation routes of exposure. Information has been presented for both acute oral and dermal toxicity. Additionally, the toxicokinetics assessment indicates that exposure via oral, dermal or inhalation will result in comparable adsorption, distribution, metabolism, and excretion. Therefore, further testing of the acute inhalation toxicity is not scientifically necessary as the available toxicity studies adequately represent the toxicity profile of the registered substance.Annex VIII 8.5 indicates that in addition to the oral route, the information shall be provided for at least one other route (dermal or inhalation). The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The dermal route is the appropriate second route as inhalation is unlikely due to the vapour pressure of ≤ 0.0000858 Pa at 20 °C. Skin contact during use as a textile fiber lubricant/finish is likely and the absorption through the skin is anticipated to be identical to the oral or inhalation routes of exposure. Information has been presented for both acute oral and dermal toxicity. Additionally, the toxicokinetics assessment indicates that exposure via oral, dermal or inhalation will result in comparable adsorption, distribution, metabolism, and excretion. Therefore, further testing of the acute inhalation toxicity is not scientifically necessary as the available toxicity studies adequately represent the toxicity profile of the registered substance.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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