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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

REACH

1,4-Dioxaspiro[4.5]decane, 8-[4-(4-methylphenyl)-3-cyclohexen-1-yl]-

EC number: 603-101-3 | CAS number: 125962-78-9

Life Cycle description
Uses advised against

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-05-08 to 2018-09-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Version / remarks:

adopted on March 23, 2006; Annex 5 corrected: July 28, 2011

Deviations:

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

Version / remarks:

Council Regulation (EC) No. 761/2009 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Deviations:

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 100 mg/L (nominal)

- Sampling method: The samples (incl. control group) were analyzed undiluted due to a low water solubility with regard to the chemical structure. The test item concentration directly after preparation (0 hour) was < LOD (LOD = 0.003 mg/L) and, thus, could not be determined. Therefore, no further analysis of the test item concentration was performed during the study.

Vehicle:

yes

Remarks:

Reconstituted wtaer

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test medium (reconstituted water and test item) was freshly prepared. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was passed through a membrane filter with a pore size of 0.2 µm. The filtrate was used for the study.

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM
- Common name: Unicellular green alga
- Strain: 61.81 SAG
- Source: Pflanzenphysiologisches Institut der Universität Göttingen", Germany

ACCLIMATION
- Acclimation period: 72-h
- Culturing media and conditions: same as test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

72 h

Hardness:

24 mg/L as CaCO3 (calculated)

Test temperature:

19.6 to 22.4 °C

pH:

7.88 to 8.34

Nominal and measured concentrations:

Nominal concentrations: 100.0 mg/L;
Measured Concentration: < LOD

Details on test conditions:

TEST SYSTEM
- Test vessel: 300 mL Erlenmeyer flasks
- Type: open
- Material, size, headspace, fill volume: 300 mL Erlenmeyer glass flasks filled with 100 mL cell suspension
- Aeration: no
- Initial cells density: 10 000 cells per ml
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to OECD TG 201
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Light intensity and quality: The light intensity measured immediately before start of the study was 7256 Lux ± 2.7% and 7329 Lux ± 3.1% at the end of the study.

EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: electronic particle counter

TEST CONCENTRATIONS
- Nominal test concentration: 100 mg/L

Reference substance (positive control):

Remarks:

potassium dichromate

Key result

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: > 0.003 mg/L (LOD)

Key result

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: > 0.003 mg/L (LOD)

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: > 0.003 mg/L (LOD)

Key result

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Yield

Remarks on result:

other: > 0.003 mg/L (LOD)

Key result

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Yield

Remarks on result:

other: > 0.003 mg/L (LOD)

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Yield

Remarks on result:

other: > 0.003 mg/L (LOD)

Details on results:

No significant effect on growth of the algae was observed at a nominal concentration of 100 mg/L, i.e. up to the maximum water solubility.
- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Unusual cell shape: no
- Colour differences: no
- Effect concentrations exceeding solubility of substance in test medium: yes

Results with reference substance (positive control):

For the reference item, potassium dichromate, the following EC values (Growth rate and Yield), NOEC and LOEC were determined:
72h EC50 of 0.86 mg/L (95 % CI: 0.78 - 0.94 mg/L) for growth rate
72h EC50 of 0.43 mg/L (95 5 CI: 0.41 -0.45 mg/L) for yield
72h NOEC: 0.4 mg/L
72 LOEC: 0.2 mg/L

Validity of the Test

In the control group, the biomass increased by a factor of 121.0 over 72 hours. Therefore, the validity criterion of increase of biomass by at least a factor of 16 within three days was fulfilled. The mean coefficient of Variation of the daily growth rates in the control group (section-by-section growth rates) during 72 hours was 17.3 %. According to the OECD test guideline, the mean coefficient of Variation must not be higher than 35 %. Thus, the validity criterion was fulfilled. The coefficient of Variation of the average specific growth rates in the replicates of the control group after 72 hours was 0.7 %. According to the OECD test guideline, the coefficient of Variation must not be higher than 7 %. Thus, the validity criterion was fulfilled.

Coefficient of Variation of the average specific growth rates in the replicates of the control:

Control replicate no.	Section-by-section arithmetic means 0 – 72-h (1/d)
1	1.5783
2	1.6085
3	1.5936
4	1.5984
5	1.6064
6	1.6002
CV	0.7%

The mean of the replicate coefficients of Variation of the daily growth rates in the control group (section-by-section growth rates) during 72 hours:

Control replicate no.	Coefficients of Variation (CV)
1	19.1%
2	12.0%
3	14.2%
4	18.3%
5	18.3%
6	22.1%
Mean	17.3%

Results

Algal Growth Measurement

Algal biomass (cell number) after 24, 48 and 72 hour exposure:

Nominal concentration [mg/L]	*Biomass of algae (Cell number per mL)**
Control		0 hours	24 hours	48 hours	72 hours
		1.0000	3.4470	21.0294	113.8590
		1.0000	4.1247	20.5524	124.6590
		1.0000	3.8430	19.8567	119.1870
		1.0000	3.5460	19.6830	120.9240
		1.0000	3.5874	19.5930	123.8580
		1.0000	3.3147	18.7767	121.5810
	Mean	1.0000	3.6438	19.9152	120.6780
	SD	0.00000	0.29351	0.78801	3.88738
	CV	0.0	8.1	4.0	3.2
100.0		0 hours	24 hours	48 hours	72 hours
		1.0000	3.3570	19.0413	119.0880
		1.0000	3.6063	19.8450	124.9110
		1.0000	3.3597	19.7820	123.7950
		1.0000	3.4983	20.8413	128.0070
		1.0000	3.7197	20.8620	128.2770
		1.0000	3.3003	19.0026	119.9340
	Mean	1.0000	3.4736	19.8957	124.0020
	SD	0.00000	0.16455	0.82110	3.89566
	CV	0.0	4.7	4.1	3.1

*Cell number divided by factor 10000

Yield

Yield after 24, 48 and 72 hour exposure:

Nominal concentration [mg/L]	Yield
Control		24 hours	48 hours	72 hours
		2.4470	20.0294	112.8590
		3.1247	19.5524	123.6590
		2.8430	18.8567	118.1870
		2.5460	18.6830	119.9240
		2.5874	18.5930	122.8580
		2.3147	17.7767	120.5810
	Mean	2.6438	18.9152	119.6780
	SD	0.29351	0.78801	3.88738
	CV	11.1	4.2	3.2
100.0		24 hours	48 hours	72 hours
		2.3570	18.0413	118.0880
		2.6063	18.8450	123.9110
		2.3597	18.7820	122.7950
		2.4983	19.8413	127.0070
		2.7197	19.8620	127.2770
		2.3003	18.0026	118.9340
	Mean	2.4736	18.8957	123.0020
	SD	0.16455	0.82110	3.89566
	CV	6.7	4.3	3.2

Mean Specific Growth Rate

Mean specific growth rate after 24, 48 and 72 hour exposure:

Nominal concentration [mg/L]	Mean specific growth rate
Control		24 hours	48 hours	72 hours
		1.238	1.523	1.578
		1.417	1.511	1.609
		1.346	1.494	1.594
		1.266	1.490	1.598
		1.277	1.488	1.606
		1.198	1.466	1.600
	Mean	1.290	1.495	1.598
	SD	0.0790	0.0198	0.0109
	CV	6.1	1.3	0.7
100.0		24 hours	48 hours	72 hours
		1.211	1.473	1.593
		1.283	1.494	1.609
		1.212	1.492	1.606
		1.252	1.518	1.617
		1.314	1.519	1.618
		1.194	1.472	1.596
	Mean	1.244	1.495	1.607
	SD	0.0470	0.0206	0.0105
	CV	3.8	1.4	0.7

Morphological Appearance

No morphological changes of the treated algae in comparison to the control algae were observed.

EC-Values

For the test item the following EC values were determined:

Parameter (0-72h)

Growth rate

Yield

EC₁₀

95% confidence interval

> 0.003 mg/L (nominal >100 mg/L)

n.d.