Registration Dossier
Registration Dossier
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EC number: 295-980-1 | CAS number: 92201-50-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cinnamomum camphora, Lauraceae.
Endpoint summary
Administrative data
Description of key information
Camphor white oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage and its reported variation of each constituent is known.
Therefore, it has been decided that the ecotoxicity of Camphor white oil will be derived from knowledge of the constituents: constituents approach. The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents (as reported in endpoint summary discussions for each species).
Short-term toxicity to fish is provided in the dataset even if the tonnage band (1 -10 tonnes/year) does not require that endpoint. Indeed that endpoint is fulfilled according to environmental classification rules. Classification should be derived from the most sensible species. Because toxicity data have demonstrated the lowest LC50 values for constituents, it has been decided to calculate fish LL50, in order to ascertain the classification for environment of Camphor white oil.
Acute toxicities to aquatic organisms property have been investigated using a calculation method named iSafeRat® that replaces OECD 201, 202 and 203 studies and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). Two compositions have been investigated, the typical composition proposed by the Lead registrant and a theoretical worst case composition, derived from data supplied in the SIP that maximizes the concentration of the most toxic constituents.
The lethal and effective loading rates (96h-LL50, 48h-EL50, 72h-ErL50) of the WAF are determined by using a series of calculation steps using phase equilibrium thermodynamics and excluding the non-bioavailable fraction. This approach is based on validated data derived from tests on fish, daphnid and algae, for which the concentrations of the test item had been determined by chemical analyses over the test period. The E(L)C50s of each constituent were predicted using the iSafeRat QSAR model, and then used to determine the mixture ecotoxicity.
Using the worst case composition of Camphor white oil, ecotoxicity results are as follow:
- Fish: 96-h LL50 was 2.9 mg test material/L
- Aquatic Invertebrate: 48-h EL50 was 4.2 mg test material/L
- Algae: 72-h ErL50 was 4.9 mg test material/L
Based on these results, Camphor white oil would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.
Additional information
CLP Classification proposal
It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).
Acute aquatic hazard: not classified. Reasoning: lowest E(L)L50 higher than 1 mg/L.
Chronic aquatic hazard: category 2. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)L50 value is between 1 and 10 mg/L, rapidly degradable substance but with some constituents having Log Kow > 4.
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