Registration Dossier
Registration Dossier
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EC number: 220-552-8 | CAS number: 2809-21-4
Toxicity to birds
Administrative data
Link to relevant study record(s)
Description of key information
The need for a long-term reproductive toxicity to birds is waived based on:
- low toxicity based on short-term avian toxicity data:
14-day acute toxicity study with Anas platyrhynchos derived a NOEC of >284 mg/kg bw/day as HEDP acid;
14-day acute toxicity study with Colinus virginianus derived a NOEC of >284 mg/kg bw/day as HEDP acid;
- mammalian toxicity data are available to assess effects on secondary poisoning and predators
- the substance is non-bioaccumulative
Key value for chemical safety assessment
Additional information
Column 2 of REACH Annex XI states that any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. For HEDP substances there is no need to carry out further long-term testing with birds for the following reasons:
• Short-term (14-day) oral toxicity studies are available for the read-across substance (HEDP-H) with Bob White and Mallard Ducks. These showed no mortality or signs of abnormal behaviour or appearance at oral doses up to 284 mg/kg bw (the highest dose tested). The LD50 was therefore >284 mg HEDP-H/kg.
• There is an extensive data base of mammalian toxicity data for HEDP substances. Data for oral exposure shows that HEDP substances is of low hazard to mammals. The effects seen can generally be attributed to complexation of metals which is a physico-chemical effect and is unlikely to be species-specific. A DNEL for secondary poisoning has been derived based on the available mammalian toxicity data and it is considered that this is also protective of avian species.
• HEDP substances are not bioaccumulative and adsorbs strongly onto sediment and soil. The low bioaccumulation potential and bioavailability of the substance in the environment means that exposure via the food chain is not significant. This is demonstrated by the low RCRs obtained for secondary poisoning.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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