Registration Dossier
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EC number: 265-314-4 | CAS number: 65036-46-6
Toxicity to aquatic plants other than algae
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic plants other than algae
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across from the alternative salt form of the registered substance is justified as per the document attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- Deviations:
- no
- Guideline:
- other: Commission Regulation (EU) 2016/266
- Deviations:
- no
- Test organisms (species):
- Lemna gibba
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 7 d
- Nominal and measured concentrations:
- Nominal: 0 (control), 10, 22, 46, 100, 220 mg/L
Initial measured: 0 (control), 2.517, 6.892, 16.225, 36.043, 91.817 mg/L - Key result
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 91.817 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- Signs of phytotoxicity were observed in the treatment groups 10 mg/L and higher on day 5 and in treatment groups 22 mg/L and higher on day 7.
The toxicity results of the main study are consistent with the results from preliminary tests. - Results with reference substance (positive control):
- The EC50(7d) of the reference substance 3,5 Dichlorphenol was 7.10 mg/L.
- Conclusions:
- The growth inhibition test on Lemna Gibba on the source substance showed signs of phytotoxicity in the treatment groups >10 mg/L on day 5 and in treatment groups >22 mg/L on day 7. The EC10 for the registered substance is 91.817 mg/L based on initial measured concentration.
Reference
Table 1: Effect concentrations based on nominal concentration (mg/L) after
7 days for the response variable average specific growth rate
| Effect concentration [mg/L] | Average specific growth rate based on frond number [mg/L] |
Average specific growth rate based on dry weight [mg/L] |
| ErC10 (95% CL) |
>220 - |
>220 - |
| ErC20 (95% CL) |
>220 - |
>220 - |
| ErC50 (95% CL) |
>220 - |
>220 - |
| NOErC | ≥220 | ≥220 |
| LOErC | >220 | >220 |
– insufficient data for calculation
Table 2: Effect concentrations based on initial measured concentration (mg/L) after
7 days for the response variable average specific growth rate
| Effect concentration [mg/L] | Average specific growth rate based on frond number [mg/L] |
Average specific growth rate based on dry weight [mg/L] |
| ErC10 (95% CL) |
>91.817 - |
>91.817 - |
| ErC20 (95% CL) |
>91.817 - |
>91.817 - |
| ErC50 (95% CL) |
>91.817 - |
>91.817 - |
| NOErC | ≥91.817 | ≥91.817 |
| LOErC | >91.817 | >91.817 |
– insufficient data for calculation
Table 3: Effect concentrations based on nominal concentration (mg/L) after 7 days for the response variable yield
| Effect concentration [mg/L] | Yield based on frond number [mg/L] |
Yield based on dry weight [mg/L] |
| ErC10 (95% CL) |
>220 - |
>220 - |
| ErC20 (95% CL) |
>220 - |
>220 - |
| ErC50 (95% CL) |
>220 - |
>220 - |
| NOErC | ≥220 | ≥220 |
| LOErC | >220 | >220 |
Table 4: Effect concentrations based on initial measured concentration
(mg/L) after 7 days for the response variable yield
| Effect concentration [mg/L] | Yield based on frond number [mg/L] |
Yield based on dry weight [mg/L] |
| EyC10 (95% CL) |
>91.817 - |
>91.817 - |
| EyC20 (95% CL) |
>91.817 - |
>91.817 - |
| EyC50 (95% CL) |
>91.817 - |
>91.817 - |
| NOEyC | ≥91.817 | ≥91.817 |
| LOEyC | >91.817 | >91.817 |
– insufficient data for calculation
Table 5: Signs of phytotoxicity were observed in the treatment groups 10 mg/L
and higher on day 5 and in treatment groups 22 mg/L and higher on day 7
| Nominal concentration [mg/L] | Vessel No. | Morphological changes, signs of phytotoxicity | ||
| Day 2 | Day 5 | Day 7 | ||
| o (control) | 1-6 | 0 | 0 | 0 |
| 10 | 7-9 | 0 | 8 | 0 |
| 22 | 10-12 | 0 | 8 | 9(++) |
| 46 | 13-15 | 0 | 8 | 6(+) |
| 100 | 16-18 | 0 | 8 | 3, 6(++) |
| 220 | 19-21 | 0 | 8 | 6 |
Explanation of abbreviations:
0: No findings
1: frond or root yellowing (chlorosis)
2: fronds humped or swollen (gibbosity)
3: small fronds
4: shortened roots
5: no roots
6: plants fragmented (fronds and/or roots)
7: dead white plant tissue (necrosis)
8: plants colored by test substance (roots are yellowish)
9: plants increased (fronds and/or roots)
(+): slight effects
(++): medium effects
(+++): strong effects
Description of key information
In an OECD 221 Lemna growth inhibition study on the read-across substance, 7 day ErC50 values for the growth rate based on initial concentrations were >91.817 mg/L. The EyC50 for the yield was determined to be >91.817 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater plants:
- 91.817 mg/L
- EC10 or NOEC for freshwater plants:
- 91.817 mg/L
Additional information
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.
