Oral toxicity tests: REACH registrants could omit acute oral toxicity tests
What are the different levels of toxicity?
- The level of toxicity can be measured by the time and amount of the exposure to the toxic product. We can distinguish 3 main levels of toxicity: acute toxicity, chronic toxicity and sub-acute toxicity.
- Acute toxicity describes the adverse effects of a substance that result from a single exposure to a toxicant or other stressor.
- Chronic toxicity describes the adverse effects of a substance that result from a long term exposure to a toxicant or other stressor.
- Sub-acute toxicity describes the adverse effects of a substance that result from multiple short term exposures to a toxicant or other stressor.
ECHA�s study on oral toxicity
In the wake of the study led by ECHA in December 2016, the results show that low oral toxicity in sub-acute tests may not require additional acute oral tests. Indeed, the study suggests that low acute oral toxicity can be predicted from the results of low toxicity in oral sub-acute toxicity studies.
The agency estimates that about 550 chemical registrants will be able to omit in vivo acute oral studies.
Furthermore, the Agency has recommended that registrants� use results from a 28-day oral toxicity study as part of a weight-of-evidence approach in their acute toxicity approach.
Results show correlation between sub-acute and acute oral toxicity
Registrant that would like to use the sub-acute toxicity results in their dossier will need to report the following findings: - Results from a 28-day oral toxicity study - Cytotoxicity tests - Qsar - Physico-chemical information about the product.
On the eve of the 2018 registration deadline, ECHA estimates that about one third of the 5,200 substances that have to be registered will need information for the acute oral toxicity endpoint.
Would like to know more about the topic?
For more information, do not hesitate to check out both ECHA �s website and our registration pages or to contact us at contact@ecomundo.eu. You can also call us at +33 (0)1 83 64 20 54 for Europe or +1 (778) 234 1607 for North America. Our experts are happy to help!
What are the different levels of toxicity?
- The level of toxicity can be measured by the time and amount of the exposure to the toxic product. We can distinguish 3 main levels of toxicity: acute toxicity, chronic toxicity and sub-acute toxicity.
- Acute toxicity describes the adverse effects of a substance that result from a single exposure to a toxicant or other stressor.
- Chronic toxicity describes the adverse effects of a substance that result from a long term exposure to a toxicant or other stressor.
- Sub-acute toxicity describes the adverse effects of a substance that result from multiple short term exposures to a toxicant or other stressor.
ECHA�s study on oral toxicity
In the wake of the study led by ECHA in December 2016, the results show that low oral toxicity in sub-acute tests may not require additional acute oral tests. Indeed, the study suggests that low acute oral toxicity can be predicted from the results of low toxicity in oral sub-acute toxicity studies.
The agency estimates that about 550 chemical registrants will be able to omit in vivo acute oral studies.
Furthermore, the Agency has recommended that registrants� use results from a 28-day oral toxicity study as part of a weight-of-evidence approach in their acute toxicity approach.
Results show correlation between sub-acute and acute oral toxicity
Registrant that would like to use the sub-acute toxicity results in their dossier will need to report the following findings: - Results from a 28-day oral toxicity study - Cytotoxicity tests - Qsar - Physico-chemical information about the product.
On the eve of the 2018 registration deadline, ECHA estimates that about one third of the 5,200 substances that have to be registered will need information for the acute oral toxicity endpoint.
Would like to know more about the topic?
For more information, do not hesitate to check out both ECHA �s website and our registration pages or to contact us at contact@ecomundo.eu. You can also call us at +33 (0)1 83 64 20 54 for Europe or +1 (778) 234 1607 for North America. Our experts are happy to help!
