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EC number: 204-528-4
CAS number: 122-20-3
intrinsic properties of the Substance indicate that significant and
relevant long-term effects on fish will not occur (NOEC = 32 mg/L).
The information requirements will be
fulfilled using a weight-of-evidence approach based on the scheme
provided in REACH Guidance Document R.7b (v4.0, ECHA, 2017: Figure
R.7.8-2) and in accordance with Annex XI Section 1.2.
Step 1: The structure as well as the
physico-chemical properties of the Substance are clearly identified. In
screening tests the Substance was found to be not readily biodegradable.
However, in the water/sediment system the Substance has a half-life of
14.3 days under aerobic conditions. After 30 and 60 days of exposure 39%
and 64% of the applied radioactivity were recovered as 14CO2,
respectively, indicating that the Substance will not persist in aerobic
aqueous compartments. In anaerobic media no biodegradation was observed
after 6 month of exposure. In natural soil the Substance is mineralized
to an extent of 66 to 72%. Therefore, the Substance is not rapidly or
inherently biodegradable in regulatory terms but it does not persist in
water/sediment systems due to degradation in surface water and in soil.
The Substance is not P/vP.
Step 2: The substance does not produce an
alert for protein binding in the schemes by OECD and OASIS (OECD QSAR
Toolbox v4.4) which is an indication of the absence of elevated
toxicity. According to the mode of action by OASIS (OECD QSAR Toolbox
v4.4), the substance is a narcotic amine. The modified classification
scheme of Verhaar is not suitable to classify the Substance. It can be
concluded that critical long-term effects are not to be expected.
Step 3 and 4: No experimental data are
available on the long-term toxicity to fish for the Substance.
Step 4a/b: Reliable QSAR predictions or
in-vitro results for long-term toxicity to fish are not available.
Step 5: Acute and long-term toxicity for the
aquatic environment have been assessed by experimental data for the
Substance itself as well as a QSAR approach on the long-term toxicity to
aquatic invertebrates. Information on the long-term toxicity to fish are
not available. Fish are not the most sensitive aquatic trophic level
(96-h LC50 = 3158 mg/L). The Substance is neither acutely nor
chronically hazardous to the aquatic environment according to the
CLP-Regulation (EC) No 1272/2008.
The long-term toxicity to fish is derived
using the Acute-to-Chronic (ACR) approach.
The ACR approach is an important method to
predict acceptable no-effect values (NOEC) from acute toxicity data
(LC50, EC50). The method is valuable for the risk assessment of chemical
substances, which has been successfully assessed for several chemicals,
including organic substances (including alkylamines) with a narcotic
mode of action (modified acute aquatic toxicity classification of
Verhaar) to which the Substance belongs (May et al., 2016; Kienzler et
al., 2016; ECETOC, 2003). Based on these three publications, a
conservative ACR of 100 was selected which covers at least 90% of all
organic chemicals; therefore, the derived NOEC can be regarded as
reliable and sufficiently protective. Based on the available 96-h LC50
of 3158 mg/L (BASF AG, 1987) a NOEC for the long-term toxicity to fish
of 32 mg/L was derived. The available short-term as well as the
long-term toxicity data do not lead to a classification of the Substance
as chronically hazardous to the aquatic environment following the
CLP-Regulation (EC) No 1272/2008. With regard to the PBT assessment,
further testing is also not required as the Substance is neither
persistent (P) nor very persistent (vP). The Substance is also neither
bioaccumulative (B) nor very bioaccumulative (vB) based on the low log
Kow (log Kow < 3, see IUCLID Chapter 4.7) and the experimentally
determined BCF (BCF << 2000 L/kg; NITE, 1992). The available short-term
as well as the long-term toxicity data for the three trophic levels
(fish, aquatic invertebrates and algae) do not indicate a concern for a
high sensitivity of aquatic organisms. In addition, the Substance holds
no relevant classification. Therefore, further testing does not seem
justified and long-term toxicity testing on fish should therefore not be
carried out to avoid unnecessary testing on vertebrate animals. Avoiding
unnecessary testing of vertebrate animals is also in line with the REACH
regulation, which states in §25 that testing on vertebrate animal shall
be undertaken as a last resort. This is further supported by the EU
Directive on the protection of animals used for scientific purposes (EU,
2010) and the EURL ECVAM strategy to replace, reduce and refine the use
of fish in aquatic toxicity and bioaccumulation testing (EURL ECVAM,
2014). Step 6: The intrinsic properties of the Substance indicate that
significant and relevant long-term effects on fish will not occur. The
Substance has no specific mode of action and does not produce structural
alerts for relevant effects. The derived NOEC of 32 mg/L indicates that
long-term effects on fish are not to be expected. Therefore and in
accordance with REACH Regulation 1907/2006, Annex XI, Section 1.2,
further testing on vertebrate animals will be omitted for reasons of
animal welfare. The Registrant will not perform a long-term toxicity
test on fish.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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