Reaction mass of undec-8-enal and undec-9-enal and undec-10-enal

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

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:

other: The result derived from read across is sufficiently reliable because all Annex XI criteria are met.

Justification for type of information:

The read across justification for Daphnia is presented in the endpoint summary and the accompanying files are also attached, in the Aquatic endpoint summary.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL 1.2-1.5 mg/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.7 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL 1.4-1.9 mg/L

Validity criteria fulfilled:

yes

Remarks:

adequate and reliable documentation on the read across is provided

Conclusions:

Intreleven aldehyde is concluded to have a 48h EC50 value of 1.4 mg/L, based on the result of the read across substance Floral Super.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 July - 27 August 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The information is used for read across to Intreleven aldehyde.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Test concentrations were verified by chemical analysis. Water samples (2 mL, in duplicate) were taken from the approximate centre of the test vessels of the control and each exposure level at the start and end of both 24-h (renewal) periods. Samples were stored in the freezer until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: WSF
Floral Super was not completely soluble in test medium at the loading rate initially prepared. No correction was made for the purity/composition of the test substance.
* test medium: adjusted ISO medium
* loading rate: 100 mg/L
* stirring period: one day of magnetic stirring in a closed vessel to reach the maximum solubility of the test substance in the test medium
* phase separation: after stirring, the aqueous mixture was left to stabilize for 60 to 100 minutes whereafter the clear and colourless Water Soluble Fraction (WSF) was siphoned out and used as the highest test concentration (range-finding test)
* test concentration range: lower test concentrations for both the range-finding test and the final test were prepared by subsequent dilutions of the WSF in test medium

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (Straus 1820)
- Strain: not stated
- Source: in-house laboratory culture with a known history (at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions)
- Age at study initiation: young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old
- Method of breeding: start of each batch with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel. Renewal of the cultures: after 7 days of cultivation half of the medium twice a week.
- Feeding during test: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20-21 °C

pH:

7.6-8.0

Dissolved oxygen:

8.4 - 9.0 mg O2/L
test end: max. 8.9 mg O2/L

Nominal and measured concentrations:

Based on the results of the range-finding test (biological effects observed in all treatment groups (1.0, 10 and 100% of WSF prepared at 100 mg/L) the following nominal test concentrations were assigned to the final test: 0.46, 1.0, 2.2, 4.6, 10 and 22% of a WSF prepared at a loading rate of 100 mg/L.

Measured test concentrations: see tables 1 and 2 in field 'Any other information on results'.

The effect concentrations are based on the mean of the initial measured exposure concentrations.

Details on test conditions:

TEST SYSTEM
The final tests were performed in closed airtight all-glass vessels (60 mL) completely filled up with test solutions.

* Range-finding test (static):
- Three test concentrations (1.0, 10 and 100% WSF prepared at 100 mg/L) plus one control each in duplicate with 5 animals/test vessel (i.e. 10 animals/concentration).

* Final test (semi-static):
- Six test concentrations (0.46, 1.0, 2.2, 4.6, 10 and 22% of WSF prepared at 100 mg/L) plus one control, each in 4-fold with 5 animals/test vessel (i.e. 20 animals/concentration).
- Loading rate: 12 mL test solution per organism
- Test vessels were maintained at 20 °C under a photoperiod of 16 hours light : 8 hours dark and without supplementary aeration or feeding during the 48 hour exposure period.
- The temperature in each vessel, the pH and dissolved oxygen levels were recorded at the start and at the end of the study.

TEST MEDIUM / WATER PARAMETERS
- Test medium: adjusted ISO
- Culture medium different from test medium: yes (M7)

OTHER TEST CONDITIONS
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED: Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (September 2015)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL 1.2-1.5 mg/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.7 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL 1.4-1.9 mg/L

Details on results:

* Range-finding test:
Samples taken from 1.0 and 10% of the WSF were analysed. At the start of the test the actual concentrations were 0.40 and 4.2 mg/l, respectively. These concentrations remained stable during the first 24 hours of exposure (99-100% of initial) but decreased during the last 24 hours of exposure (6.3-48% of initial at the end of the test).

* Final test:
Measured concentrations ranged from 93 - 100 % of inital at the end of the first renewal period (t=0-24 hours) and 90-97 % of initial at the end of the second renewal period (t=24-48 hours).
During both 24-h exposure periods the test concentrations remained stable.

Individual pH, temperature and dissolved oxygen values remained within acceptable limits throughout the duration of the study.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- 24-h EC50: 0.80 mg/L
- 48-h EC50: 0.39 mg/L

Table 1: Concentrations of the test item in test medium - final test

Time of sampling [days]	Percentage of WSF^1 [%]	Analysed concentration^2 [mg/L]	Relative to initial [%]
0	0	n.d.
(fresh)	0.46	0.177
	1.0	0.385
	2.2	0.855
	4.6	1.79
	10	4.03
	22	8.82
1	0	n.d.
(old)	0.46	0.177	100
	1.0	0.357	93
	2.2	0.820	96
	4.6	1.71	96
	10	3.80	94
	22	8.61	98
1	0	n.d.
(fresh)	0.46	0.172
	1.0	0.429
	2.2	0.936
	4.6	1.92
	10	4.33
	22	9.47
2	0	n.d.
(old)^3	0.46	0.167	97
	1.0	0.388	90
	2.2	0.907	97
	4.6	1.81	94

1 Percentage of a water soluble fraction (WSF) prepared at a loading rate of 100 mg/L.

2 Samples were stored in the freezer (≤ -15°C) until the day of analysis.

3 10% and 22% WSF test solutions were not used on day 2 of the test as all daphnids were immobolie within 24 hours, hence no analysis was performed.

n.d.    Not detected.

Table 2: Nominal, initial and mean initial exposure concentrations

Floral Super % of WSF prepared at 100 mg/L	Initial concentration (mg/L)		Mean initial concentration  (mg/L)
	t=0 h	t=24 h
0.46	0.177	0.172	0.17
1.0	0.385	0.429	0.41
2.2	0.855	0.936	0.90
4.6	1.79	1.92	1.9
10	4.03	-	4.0
22	8.82	-	8.8

Test concentrations were prepared and analysed (see Table 1) but no organisms were exposed as all daphnids were immobile within 24 hours. Therefore, only the results of the initial concentrations at the first renewal period were used.  

Range-finding test

From 24 hours onwards all daphnids exposed to 10 and 100% of the WSF were immobilized. After 48 hours of exposure two daphnids exposed to 1.0% of the WSF were immobilized. No immobility was observed in the control, although 3 daphnids were observed trapped at the surface of the medium.

 

Final test

Table 3: Cumulative immobilisation data for Daphnia magna exposed for 48 hours to the test substance

 

%WSF prepared at 100 mg/L	Mean initial measured concentration [mg/L]	Cumulative immobilised Daphnia magna (initial population: 5 per replicate)
		24 hours						48 hours
		A	B	C	D	total	%	A	B	C	D	total	%
Control		0	0	0	0	0	0	0	0	1	0	1	5
0.46	0.17	0	0	0	0	0	0	0	0	0	0	0	0
1.0	0.41	0	0	0	0	0	0	0	0	0	0	0	0
2.2	0.90	0	0	0	1	1	5	0	0	0	0	0	0
4.6	1.9	2	4	4	4	14	70	5	5	5	5	20	100
10	4.0	5	5	5	5	20	100	5	5	5	5	20	100
22	8.8	5	5	5	5	20	100	5	5	5	5	20	100

 A, B, C, D = replicate 1, 2, 3, 4

Validity criteria fulfilled:

yes

Remarks:

<10% (5%) immobilization in control group, O2 conc. at the end is >=3 mg/L (8.7-8.9) in control and test vessels

Conclusions:

The 48-h EC50 for Daphnia magna is 1.4 mg/L.

Executive summary:

A study was performed to assess the acute toxicity of the substance to Daphnia magna under semi-static conditions (renewal period: 24 hours). The study was conducted in accordance with OECD TG 202 and GLP. Groups of twenty daphnids were exposed for 48 hours to the following six concentrations of the substance dispersed in test water: 0.46, 1.0, 2.2, 4.6, 10 and 22 % of a WSF prepared at a loading rate of 100 mg/L. Measured concentrations ranged from 93 - 100 % of initial at the end of the first 24 hour period, and 90 - 97 % of initial at the end of the second 24 hour period. Because the concentrations in the solutions were stable, mean initial measured concentrations were calculated and they were: 0.17, 0.41, 0.90, 1.9, 4.0 and 8.8 mg/l. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. 48-h EC50 was determined to be 1.4 mg/L, expressed as mean initial measured concentration.

Description of key information

The 48h EC50 for Daphnia is 1.4 mg/L, based on the result of the read across substance Floral Super tested in OECD TG 202.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1.4 mg/L

Additional information

Intreleven aldehyde information is derived from read across from Floral Super. It is concluded to have a 48h EC50 of 1.4 mg/L, based on the result of Floral Super. The Daphnia study of Floral Super is summarized below. The read-across justification is presented in the Aquatic Endpoint summary. The accompanying files are also attached there.

The OECD 201 Daphnia study with Floral Super used for read-across to Intreleven aldehyde:

A study was performed to assess the acute toxicity of Floral Super to Daphnia magna under semi-static conditions (renewal period: 24 hours). The study was conducted in accordance with OECD TG 202 and GLP. Groups of twenty daphnids were exposed for 48 hours to the following six concentrations of the substance dispersed in test water: 0.46, 1.0, 2.2, 4.6, 10 and 22 % of a WSF prepared at a loading rate of 100 mg/L. Measured concentrations ranged from 93 - 100 % of initial at the end of the first 24 hour period, and 90 - 97 % of initial at the end of the second 24 hour period. Because the concentrations in the solutions were stable, mean initial measured concentrations were calculated and they were: 0.17, 0.41, 0.90, 1.9, 4.0 and 8.8 mg/l. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. 48-h EC50 was determined to be 1.4 mg/L, expressed as mean initial measured concentration.