Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
cell number
Details on results:
No NOEC was determined.
TEAC showed toxicity in the range-finding test at the highest concentration, but the inhibition was < 50%.
Validity criteria fulfilled:
not applicable
Conclusions:
The nominal 96h-EC50 of Tetraethylammonium chloride to algae based on cell number was >1000 mg/L. This result is read across to TEAH.
Executive summary:

The toxicity of Tetraethylammonium chloride to Pseudokirchnerella subcapitata was examined in a combined limit/range-finding study carried out according to EPA OTS 797.1050. Six nominal concentrations were tested: 0.01, 0.1, 1.0, 10, 100 and 1000 mg/L.

The nominal 96h-EC50 of Tetraethylammonium chloride to algae based on cell number was >1000 mg/L.

No NOEC was determined. The cell number data in the report are in a handwritten appendix and insufficiently readable for determination of the NOEC by the reviewer.

The study was not carried out according to GLP and nominal concentrations were not verified by chemical analyses. Therefore the study is considered as reliable with restrictions. The study can be used in a weight-of-evidence approach. This result is read across to TEAH.

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 251 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
31.4 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Details on results:
[DOC measurements]

The recovery rates based on DOC measurements were > 80%

[Effect Data]
Table 2. Percent inhibition of the cell growth and the average specific growth rates in the 72-hour growth inhibition test on Scenedesmus subspicatus
============================================================
Nominal conc. growth Rate
rate# related
(mg/l) (mgTMAH/l) inhibition
(%)
------------------------------------------------------------
control 1.39 ---
-----------------------------------------------------------
pH control pH control
of 1,000 of 251 (-)1.37 1.47
mg/L mg/L
neutralised neutralised
-----------------------------------------------------------
31.25 7.84 (-)1.40 -0.41
-----------------------------------------------------------
62.5 15.7 (-)1.39 0.22
-----------------------------------------------------------
125 31.4 (-)1.34 3.87
-----------------------------------------------------------
250 62.8 (+)1.32 4.92
-----------------------------------------------------------
500 126 (+)1.29 6.98
-----------------------------------------------------------
1,000 251 (-)1.34 3.43
============================================================
#; Statistically significant differences of biomass integrals and growth rates compared to control values are marked(+), not significant differences are marked(-)

Table 3. Calculated EC50 values and NOEC
==================================================
Formulation(mg/L) Equivalent to 100%TMAH
(mg TMAH/L)
ErC50 >1,000 >251
NOEC(r) 125 31.4
===================================================
Results with reference substance (positive control):
Potassium dichromate: 72h-ErC50: 0.85 mg/L (95% CI 0.69-1.04 mg/L)
Validity criteria fulfilled:
yes
Conclusions:
The nominal 72h-ErC50 value and NOECr value to Desmodesmussubspicatus were >251 and 31.4 mg/L, respectively. As no significants effects were observed in the neutralised solution of 251 mg/L TMAOH (pH control), it can be concluded that the effects are pH related. This result is read across to TEAH.
Executive summary:

A toxicity test with Desmodesmus subspicatus was carried out in accordance with OECD 201, EU Method C.3 (Algal Inhibition test) and GLP. The nominal 72h-ErC50 value and NOECr value to Desmodesmus subspicatus were >251 and 31.4 mg/L, respectively.The recovery rates of samples taken at the start and the end of the test based on DOC measurements were > 80% and therefore it is deemed acceptable to express the results as nominal values. As no significant effects was observed in neutralised solution of 251 mg/L TMAOH (pH control), it can be concluded that the effects are pH related. This result is read across to TEAH.

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
96.3 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks on result:
other: Analytical monitoring was conducted. The TMAH concentrations in test solutions were maintained within ± 20% of nominal concentrations throughout the test. Thus the value was estimated with nominal concentrations.
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
6.25 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks on result:
other: Analytical monitoring was conducted. The TMAH concentrations in test solutions were maintained within ± 20% of nominal concentrations throughout the test. Thus the value was estimated with nominal concentrations.
Details on results:
Rate method:
ErC50 (0-72 hr) = 96.3 mg/l (Table 1 - 3)
NOEC (0-72 hr) = 6.25 mg/l (Table 1, 2 & 4)

ErC50 (24-48 hr) = 74.8 mg/l (Table 1 - 3)
NOEC (24-48 hr) = 6.25 mg/l (Table 1, 2 & 4)

ErC50 (24-72hr) = >100 mg/l (Table 1 - 3)
NOEC (24-72 hr) = 6.25 mg/l (Table 1, 2 & 4)

Table 1.Chlorophyll fluorescence value and their standard
deviations (S. D.) in the test cultures and controls
==============================================================
Nominal concn Chlorophyll fluorescence value (relative unit)
(mg/l) 0 hr# 24 hr 48 hr 72 hr
-------------------------------------------------------------
Control Mean 4.15 24.8 123 490
S. D. 0.0 0.892 3.52 8.00
-------------------------------------------------------------
0.391 Mean 4.15 24.7 120 485
S. D. 0.0 0.204 1.36 21.3
-------------------------------------------------------------
1.56 Mean 4.15 20.0 100 439
S. D. 0.0 1.32 9.34 27.5
-------------------------------------------------------------
6.25 Mean 4.15 17.5 83.6 387
S. D. 0.0 1.23 1.74 58.3
-------------------------------------------------------------
25.0 Mean 4.15 10.5 40.0 188
S. D. 0.0 0.390 9.34 72.5
-------------------------------------------------------------
100 Mean 4.15 8.63 15.4 40.7
S. D. 0.0 4.71 7.09 16.2
=============================================================
#; Based on pre culture medium

Table 2.Percent inhibition of the cell growth in the 72-hour growth
inhibition test on Pseudokirchneriella subcapitata
========================================================
Nominal Area Inhibition Rate Inhibition
concn. (%) (%)
--------------------- --------------------
(mg/l) (0-72 hr) (0-72 hr)
--------------------------------------------------------
Control 9170 --- 1.59 ---
0.391 9040 1.40 1.59 0.223
1.56 7910 13.7 1.55 2.33
6.25 6820 25.6 1.51 5.14
25.0 3220 64.9 1.26 21.0
100 815 91.1 0.741 53.4
========================================================

Table 3..Percent inhibition of the average specific growth rates in the 72-hour growth
inhibition test on Pseudokirchneriella subcapitata
=======================================================
Nominal Rate Inhibition Rate Inhibition
concn. (%) (%)
--------------------- -------------------
(mg/l) (24-48 hr) (24-72 hr)
-------------------------------------------------------
Control 0.0667 --- 0.0622 ---
0.391 0.0658 1.37 0.0620 0.315
1.56 0.0671 -0.693 0.0643 -3.39
6.25 0.0652 2.17 0.0643 -3.44
25.0 0.0550 17.6 0.0591 4.93
100 0.0262 60.8 0.0341 45.2
========================================================

Table 4.Calculated EC50 values and NOEC
================================================
EC50 NOEC
(mg/l) (mg/l)
------------------------------------------------
Rate (0-72 hr) 96.3 6.25
Rate (24-48 hr) 74.8 6.25
Rate (24-72 hr) >100 6.25
================================================
Validity criteria fulfilled:
yes
Conclusions:
The nominal 72h-ErC50 value and NOECr value to Pseudokirchnerella subcapitata were 96.3 and 6.25 mg/L, respectively. This result is read across to TEAH.
Executive summary:

A toxicity test with Pseudokirchnerella subcapitata was carried out according to OECD 201 and GLP under static conditions. Analytical monitoring was conducted. The TMAH concentrations in test solutions were maintained within ± 20% of nominal concentrations throughout the test. Thus the value was estimated with nominal concentrations. The nominal 72h-ErC50 value and NOECr value were 96.3 and 6.25 mg/L, respectively. This result is read across to TEAH.

Description of key information

Based on the results of  tests with the structural analogues TEAC and TMAH, it is reasonably predicted that the EC50 of TEAH to algae is higher than 100 mg/L.
Based on the results with the structural analogue TMAH, it is reasonably predicted that the NOEC of TEAH to algae is higher than 1 mg/L.

Key value for chemical safety assessment

Additional information

There is one study available on the structural related substance Tetraethylammonium chloride (TEAC) and there are two studies available on the structural related substance Tetramethylammonium hydroxide (TMAH), which can be used in a weight-of-evidence approach (see read-across document attached in IUCLID section 13).

The toxicity of the structural analogue Tetraethylammonium chloride (TEAC) to Pseudokirchnerella subcapitata was examined in a combined limit/range-finding study carried out according to EPA OTS 797.1050 (Bollmann et al., 1989). Six nominal concentrations were testes: 0.01, 0.1, 1.0, 10, 100 and 1000 mg/L.

The nominal 96h-EC50 of Tetraethylammonium chloride to algae based on cell number was >1000 mg/L.

No NOEC was determined. The cell number data in the report are in a handwritten appendix and insufficiently readable for determination of the NOEC by the reviewer.

The study was not carried out according to GLP and nominal concentrations were not verified by chemical analyses. Therefore the study is considered as reliable with restrictions. The study can be used in a weight-of-evidence approach.

The toxicity of the structural analogue Tetramethylammonium hydroxide (TMAH) to Pseudokirchnerella subcapitata was examined according to OECD 201 and GLP under static conditions (TMAH Consortium, 2001). Analytical monitoring was conducted. The TMAH concentrations in test solutions were maintained within ± 20% of nominal concentrations throughout the test. Thus the value was estimated with nominal concentrations. The nominal 72h-ErC50 value and NOECr value were 96.3 and 6.25 mg/L, respectively.

The toxicity of TMAH to Desmodesmus subspicatus was examined in accordance with OECD 201, EU Method C.3 (Algal Inhibition test) and GLP under static conditions (Scheerbaum, 2001). The nominal 72h-ErC50 value and NOECr value to Desmodesmus subspicatus were >251 and 31.4 mg/L, respectively.

The recovery rates of samples taken at the start and the end of the test based on DOC measurements were > 80% and therefore it is deemed acceptable to express the results as nominal values. As no significant effects were observed in neutralised solution of 251 mg/L TMAH (pH control), it can be concluded that the effects were pH dependent.

Based on the results of tests with the structural analogues TEAC and TMAH, it is reasonably predicted that the EC50 of TEAH to algae is higher than 100 mg/L.

Based on the results with the structural analogue TMAH, it is reasonably predicted that the NOEC of TEAH to algae is higher than 1 mg/L.