Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 416-740-6 | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Long-term toxicity to fish - read across data
Read-across results from a chronic fish studies with the structural analog, DEHT (CAS 6422-86-2) indicate that the submission substance is not expected to produce chronic toxicity to fish at or near its maximum water solubility limits.
Key value for chemical safety assessment
Additional information
Chronic fish toxicity data were not available for the submission substance, CAS No. 162030-42-4. However, there are sufficient read-across chronic toxicity fish data reported for a structurally similar analogue, namely, DEHT (CAS 6422-86-2) to help assess the long-term toxicity potential in fish for the submission substance.
A flow-through early life stage toxicity study of DEHT to rainbow trout (Salmo gairdneri) has been reported in which trout eggs were subjected to 11 days of continuous exposure to 0.014, 0.024, 0.047, 0.15 and 0.28 mg/L of test substance. The 71-day long study monitored for 60 days post exposure the hatchability, survival and growth of the trout fry. Hatchability of the trout eggs after 11 days of exposure was not significantly affected when compared to control. Likewise, survival of fry between hatching and 60 days of exposure to all test concentrations was not reduced in any significant manner. Growth of trout fry, as measured by wet weight after 60 days of exposure to all test concentrations, was not significantly reduced. Overall, DEHT showed no effect on egg hatchability, egg survival, fry survival, or growth (length and weight) at its highest exposure test concentration (0.28 mg/L, measured) when compared with controls and under the conditions of this test. Based on these findings, the NOEC as well as MATC (maximum acceptable toxicant concentration) was estimated to be > 0.28 mg/L or 280 ug/L. Hence, DEHT did not cause chronic toxicity to fish as measured by hatchability, survival or growth.
Based on the read-across chronic non-toxicity findings for the DEHT surrogate and owing to their structural similarity, the submission substance, (CAS No.162030-42-4), also would not be expected to be cause any chronic toxicity to fish at or near its maximal water solubility limit.
The findings are consistent with the structurally similarity between these high MW C8-13 terephthalate diester materials. The absence of any chronic toxicity may be due in part to their low water solubility, resulting in low exposure potential in the aqueous compartment as well as to the ability of organisms to metabolize or biodegrade the test materials.
[Note: There are also sufficient read-across chronic toxicity data in invertebrates (e.g., Daphnia magna) to indicate that the submission substance, EC No. 416-740-6, is not likely to cause long-term aquatic toxicity to other aquatic organisms at its maximum water solubility limits (see Section 7.1.1.2.2). Other supporting test data or read-across data indicate that the submission substance is expected to cause no acute toxicity to fish, invertebrates or algae at its maximum water solubility limit.
Justification for Read-Across:
For the purpose of this assessment, data for a lower molecular weight terephthalate, di(2-ethylhexyl) terephthalate (DEHT), will be used as read-across. This read-across approach is based on the principle that substances of similar structure have similar physico-chemical properties (e.g., low water solubility, high log Kow, lipophilicity) and the premise that a narrow range of ester carbon numbers will produce analogous trends in physicochemical, environmental and toxicological properties. Both the submission substance and DEHT are composed of a 1,4-benzenedicarboxylic acid moiety with a branched alkyl alcohol attached to the acid units via an ester linkage (referred to as the alkyl side chains). The distinguishing feature between DEHT and the submission substance is in the alkyl side chains. DEHT has alkyl side chains with a 2-ethylhexyl moiety (carbon number of 8) whereas the submission substance has mixed alkyl side chains ranging in carbon backbone length from C11-C14, C13-rich mainly. Because of the similarity in structure and physicochemical properties, it is reasonable to rely on the available read-across data on DEHT to characterize the potential aquatic and terrestrial effects of the submission substance.
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.
