Alcohols, C16-18

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Samples were taken twice from selected concentration levels of the test series during the test period and analysed chemically. The first sampling was taken before the 7th day previous to any offspring appearance, the second sample was taken between day 16 and day 21. No further details on analytical methods were presented.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: the test substance was dispersed to make up a stock solution of 200 mg/L, then gradual serial dilutions (corresponding to a ratio of 1:2) of the stock solution were made to produce the concentration range tested.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Common name: water flea

- Strain: IRCHA

- Age of parental stock: maintained in accordance with the procedure practised since 1978

- Feeding during test

- Food type: Tetramin-Haupfutter (fish feed) and activated sludge.


ACCLIMATION

- Type and amount of food: dry algae Scenedsmus spp. 9g of feed were suspended in 1000 mL tap water and 2 mL were added to each 2 L cultures.

- Feeding frequency: daily



METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: pipette

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

25 +/- 1 C

pH:

average: >7

Dissolved oxygen:

>69%

Nominal and measured concentrations:

Nominal: 0.4 to 50 mg/L

Details on test conditions:

TEST SYSTEM

- Test vessel: beakers

- Material, size, fill volume: 400 ml glass beakers filled with 250 mL test water.

- Aeration: none

- No. of organisms per vessel: 5

- No. of vessels per concentration (replicates): 4

- No. of vessels per control: 4

- Biomass loading rate: 1 animal/50ml


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: deionised water was used to prepare standard artificial medium (synthetic fresh water) as stated by DIN - German Institute of Standardisation

- Culture medium different from test medium: yes, culture medium was de-chlorinated tap water

- Intervals of water quality measurement: 3 times / week


OTHER TEST CONDITIONS

- Photoperiod: 7am to 4pm

- Light intensity: fluorescent lamps - Philis TL 40/25W


EFFECT PARAMETERS MEASURED: mortality, reproduction rate and appearance of offspring, daily.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: Mortality, reproduction rate, and appearance of offspring

Details on results:

- Mortality of parent animals: 7.1%

- Time to first brood release or time to hatch: 7-8 days for the appearance of first offpsring.

- Brood size: 88 offspring

Reported statistics and error estimates:

Student's t-test and U-test for deterimining the NOEC of reproduction rate and parent mortality.

Primarily, the results were expressed with reference to the nominal concentration. If however, the chemical analysis showed a loss of tested 

substance greater than 20%, then the lowest analysed concentration (minimum value) obtained during the test was also reported for the NOEC.
The 21-d NOEC based on nominal concentrations was 1.6 mg/L.
The 21-d NOEC based on the minimum value for 1-Octanol was 1.0 mg/L.

 

The most sensitive endpoint was the appearance of first offspring.

Validity criteria fulfilled:

yes

Conclusions:

A reliable 21 day reproduction NOEC value of 1.0 mg/L has been determined for the effects of the test substance on reproduction and survival of the freshwater test organism Daphnia magna.

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

to allow aeration of exposure media.

Principles of method if other than guideline:

Deviation: As a deviation from OECD Guideline 211, all test vessels were aerated with sterile filtrated synthetic air: the autoclaved silicone stoppers were fitted with fine glass capillaries connected to the aeration unit. The aeration was necessary to avoid severe oxygen depletion due to the increase of transferred bacteria with growing Daphnia magna as observed in pre-studies and the associated oxygen consumption by the degradation of the test substance

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All the test concentrations were sampled for chemical analysis three times a week at renewal of the test media.

- Sampling method: A 500 mL aliquot of the fresh solutions was used for analysis. After 24 h, at the next renewal, the aged test liquids were pooled (vessels 1- 5 and 6-10) and analysed.

- Sample storage conditions before analysis: The test media were not stored for more than 1 - 2 hours prior to testing.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Test solutions were prepared daily by stirring the test substance in test media under slow stir conditions (21 h) in sterilized mixing vessels. The mixing vessels were cylindrical brown glass bottles with teflon covered screw caps, fitted with a drain port near the bottom for drawing off the test solution. The volume of the mixing vessels was 2 L. After stirring, the contents of the vessels were left to settle for 2 h. The saturated aqueous phase was then taken out of the drain port. The first fraction 0-100 mL was withdrawn. The fraction between 100 and 1800 mL was used for rinsing (200 mL) and filling (1000 mL) the test flasks for toxicity testing and for analytical measurements (500 mL), if done. Rinsing of the test vessels was carried out to saturate the surfaces of the test vessels. After filling, the vessels were closed immediately by using autoclaved silicone stoppers and only opened to introduce the test organisms and again at the renewals of the test media.

- Evidence of undissolved material: The test solution was not filtered as filtration was shown to cause highly variable and much lower test concentrations the water solubility predicted. When omitting the filtration process, the concentrations were clearly higher than the solubility predicted.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Common name: freshwater flea

- Source: Umweltbundesamt (German Federal Environment Agency). Test organisms bred in the laboratory of the Fh-IME (testing facility).

- Age of parental stock: 4-24 hrs.

- Feeding during test

- Food type: suspension of D. subspicatus.

- Frequency: at each test renewal


ACCLIMATION

- Acclimation conditions: renewal of waters in the cultures is weekly, not daily.

- Type and amount of food: Desmodesmus subspicatus and LiquizellR (HOBBY)

- Feeding frequency: daily


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: newborn daphnia were separated by sieving, the first generation was discarded.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Post exposure observation period:

none

Hardness:

Not reported

Test temperature:

range: 20.0 to 21.0°C

pH:

range: 9.4-9.5

Dissolved oxygen:

oxygen saturation never fell below 70 % (5.7 mg/L)

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal test concentrations were 0, 152, 411, 1110 and 3000 µg test item/L. Initial mean measured concentrations of freshly prepared test solutions were 1.6, 122, 351, 962, 2800 µg/L.
Geometric means of mean measured initial and aged concentrations after 24 h hours were See Table 3 for further details.

Details on test conditions:

TEST SYSTEM

- Test vessel: numbered vessel flask

- Type: closed, with autoclaved silicone stoppers.

- Material, size, headspace, fill volume: glass flasks, filled with 100 ml test solution.

- Aeration: yes, with sterile filtrated synthetic air through glass capillaries.

- Renewal rate of test solution (frequency):

- No. of organisms per vessel: 10

- No. of vessels per concentration: 1

- No. of vessels per control: 1


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: purified drinking water, autoclaved before use. The purification included filtration with activated charcoal, passage through a limestone column and aeration until oxygen saturation.

- Total organic carbon: DOC 1.72 mg/L

- Metals: Ca 0.6 mmol/L, Mg 0.1 mmol/L, Nitrate <0.5 mmol/L. Nitrite <0.002 mg/L, Cu 0.0031 mg/L, phosphate 0.56 mg/L, Fe 0.0066 mg/L, Mn 0.0003 mg/L, Zn 0.0075 mg/L

- Alkalinity: 1.0 mmol/L

- Ca/mg ratio: 6:1

- Conductivity: 227 uS/cm

- Intervals of water quality measurement: daily


OTHER TEST CONDITIONS

- Photoperiod: day/light cycle = 16/8 hours

- Light intensity: 588 to 657 lux


EFFECT PARAMETERS MEASURED: The parent Daphnia magna were assessed visually daily for immobility and any other abnormalities in appearance
and behaviour. At study termination, the length of the adults was measured by digital photography and image analysis and their statistics compared with those of the control animals. The newborn Daphnia magna in each beaker were counted at each daily renewal of the test solutions, inspected for abnormalities in condition, and removed. The following endpoints observed in the reproduction test were evaluated quantitatively:
o Mortality (immobility) of parental generation Daphnia magna;
o Age at first brood;
o Total number of offspring per replicate;
o Cumulative Number of live offspring per surviving female at the time of recording;
o Intrinsic rate of increase, r;
o Individual length of adults.

RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: acute toxicity test D. magna LC50 of 2300 ug/L

Reference substance (positive control):

not specified

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

210 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: reproduction rate

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

110 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: reproduction rate

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

370 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: reproduction rate

Duration:

21 d

Dose descriptor:

other: EC20

Effect conc.:

670 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: reproduction rate

Details on results:

- Mortality of parent animals: during the test no parental mortality occured, neither were any clinical signs observed, except for the highest treatment level where all animals died before reproduction.

- No. of offspring produced per day per female: see Table 1 for details.

- Body length and weight of parent animals: see Table 1 for details.

- Time to first brood release or time to hatch: see Table 1 for details.

- Brood size: see Table 1 for details.

Reported statistics and error estimates:

The evaluation of the concentration-effect-relationships and the calculations of effect concentrations were based on mean measured initial concentrations as multiple peak concentrations, as well as on geometric means between mean measured initial and aged (24h) test concentrations. For each endpoint, the NOEC, LOEC, and, if possible, the EC50, EC20 and EC10 were determined. A LOEC and NOEC were calculated by ANOVA followed by Williams' test or an appropriate non-parametric test suggested by the ToxRat program. When the test results showed a concentration-response relationship, the data were analysed by regression using Probit-analysis assuming log-normal distribution of the values using the computer program ToxRat program.

Table 1a. Survival, growth and age at first brood data (21 day).

 

Test item Nominal Conc. (μg/L)	Survival Mean ± SD (%)	Growth (length) Mean ± SD (mm)	Age at first brood Mean ± SD   (days)
Control	100	5.41 ± 0.22	8.9 ± 0.74
152	100	5.52 ± 0.19	9.2 ± 0.79
411	100	5.43 ± 0.21	9.0 ± 0.82
1,110	100	5.26 ± 0.38	9.4 ± 0.97
3,000	0	n.d.	n.d.

 

Table 1b. 21 day Reproduction data.

 

Test item nominal conc. (μg/L)	Cumulative offspring per female Mean ± SD (#)	Intrinsic rate of increase r  Mean ± SD (1/d)
Control	68.1 ± 9.5	0.294 ± 0.017
152	68.0 ± 5.6	0.297 ± 0.018
411	62.9 ± 5.8	0.281 ± 0.011
1,110	58.6 ± 7.7 *	0.277 ± 0.024 *
3,000	n.d.	n.d.

* significant difference to control according to Williams-test (a = 0.05,  one-sided smaller)

Table 2. Calculated statistics relative to offspring production rate, related to daily initial concentrations.

 

EC10	610 µg test item/L
EC20	1500 µg test item/L
LOEC	960 µg test item/L
NOEC	350 µg test item/L

 

 

Table 3. Results of analytical monitoring of the test substance. The Fresh and Old measurements are the arithmetic mean of three weekly measurements, while the Geometric mean is the geometric mean of fresh and old measurements.

 

Nominal concentration (μg/L)	Fresh (Mean (SD %)) (μg/L)	Old (Mean (SD%)) (μg/L)	Geometric Mean (μg/L)
152	122 (15%)	4.4 (119%)	23.3
411	351 (10%)	33 (109%)	107
1110	962 (30%)	140 (91%)	367
3000	2800 (10%)	537 (65%)	1227

Validity criteria fulfilled:

yes

Conclusions:

A 21 d EC10 value of 210 µg/l and NOEC value of 110 µg/L have been determined for the effects of 1-Decanol on the reproduction rate of Daphnia magna.

Executive summary:

The data was obtained generally in accordance with standard test guideline OECD 211. However some modifications to the normal guideline procedures were necessary to reduce losses of test substances due to the extensive and rapid biodegradation of the LCAAs. Gentle aeration of test vessels was required as degradative losses of LCAAs resulted in unacceptably low dissolved oxygen concentrations. Algae have been found to metabolize LCAAs and this is an unavoidable occurrence in long-term studies with Daphnia magna fed with algae. No modifications could be made to counter this without conducting further research into an alternative diet.

Reference 3

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-06-10 to 2005-10-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

to allow aeration of exposure media.

Principles of method if other than guideline:

Due to unavoidable biodegradation processes, which have to be accepted as an intrinsic and realistic feature of the test procedure, sever oxygen depletion occurred. In contradiction to the test guideline, cautious aeration with sterile filtered air was implemented to overcome this.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All the test concentrations were sampled for chemical analysis three times a week at renewal of the test media.

- Sampling method: A 500 mL aliquot of the fresh solutions was used for analysis. After 24 h, at the next renewal, the aged test liquids were pooled (vessels 1- 5 and 6-10) and analysed.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Test solutions were prepared daily by stirring the test substance in test media under slow stir conditions (21 h) in sterilized mixing vessels. The mixing vessels were cylindrical brown glass bottles with teflon covered screw caps, fitted with a drain port near the bottom for drawing off the test solution. The volume of the mixing vessels was 2 L. After stirring, the contents of the vessels were left to settle for 2 h. The saturated aqueous phase was then taken out of the drain port. The first fraction 0-100 mL was discarded. The fraction between 100 and 1800 mL was used for rinsing (200 mL) and filling (1000 mL) the test flasks for toxicity testing and for analytical measurements (500 mL), if done. Rinsing of the test vessels was carried out to saturate the surfaces of the test vessels. After filling, the vessels were closed immediately by using autoclaved silicone stoppers and only opened to introduce the test organisms and again at the renewals of the test media. The test media were not stored for more than 1 - 2 hours prior to testing.

- Controls: the controls were prepared using test media only.

- Evidence of undissolved material: the test solutions of fatty alcohols were not filtered as it was shown that the filtation procedure caused highly variable and much lower test concentrations than the water solubility predicted from physico-chemical models. When omitting the filtration procedure, the concentrations were clearly higher than the solubility predicted by models and there was no clear indication of a trend to saturation. It was therefore concluded that the measured concentrations comprised a fraction of dissolved test substance and a fraction of finely dispersed material. It was considered technically impossible to avoid the presence of very fine undissolved particles or droplets at the higher test concentrations.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Common name: freshwater water flea

- Source: Umweltbundesamt (German Federal Environment Agency). Test organisms bred in the laboratory of the Fh-IME (testing facility).

- Age of parental stock: adult daphnia at least 3 weeks old are separated from the the stock population by sieving. The test animals used in the test were 0-24h old.

- Feeding during test

- Food type: suspensions of unicellular green alga

- Amount: The content of food in the test suspensions, measured as turbidity at 758 nm, increased during the test from 7 mg C/L equivalents to 15 mg C/L equivalents.

- Frequency: fed at each water renewal.


ACCLIMATION

- Acclimation period: 1 week

- Acclimation conditions: batches of 30 to 50 animals are held at room temperature in ca. 1800 L dilution water. The water is changed once a week.

- Type and amount of food: During the week animals are fed with an algal suspension (Desmodesmus subspicatus) and LiquizellR (HOBBY) Algae growing in the log phase are centrifuged and the pellet is re-suspended in a few ml of medium. 30 ml of this suspension is given to 1L daphnia medium.

- Feeding frequency: daily

- Health during acclimation: good.


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: newborn daphnia were separated by sieving, the first generation being discarded.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Post exposure observation period:

none

Hardness:

0.7 mmol/L

Test temperature:

range 21.0 to 22.0°C

pH:

range: 9.3 to 9.5

Dissolved oxygen:

The oxygen saturation never fell below 56 % (4.0 mg/L)

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 0, 25, 69, 185 and 500 ug test item/L
Measured concentrations: test solutions were The geometric means of mean measured initial and aged concentrations after 24 h hours were

Details on test conditions:

TEST SYSTEM

- Test vessel: glass flask

- Type: closed with autoclaved silicone stoppers.

- Material, size, headspace, fill volume: sterilised glass flask, filled with 100 ml test medium

- Aeration: yes. All test vessels were aerated with sterile filtrated synthetic air: the autoclaved silicone stoppers were fitted with fine glass capillaries connected to the aeration unit. The aeration was necessary to avoid severe oxygen depletion due to the increase of transferred bacteria with growing Daphnia magna as observed in pre-studies and the associated oxygen consumption by the degradation of the test substance.

- Renewal rate of test solution: daily

- No. of organisms per vessel: 1

- No. of vessels per concentration : 10

- No. of vessels per control : 10


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: purified drinking water.

- Metals: Cu 0.0031 mg/L, Fe 0.0066 mg/L, Mn 0.0003 mg/L, Zn 0.0075 mg/L

- Alkalinity: 1.6 mmol/L

- Ca/mg ratio: Ca 0.8 mmol/L, Mg 0.1 mmol/L

- Conductivity: 202 uS/cm

- Intervals of water quality measurement:


OTHER TEST CONDITIONS

- Photoperiod: light/dark cycle of 16/8 hours

- Light intensity: in the range 585 to 647 lux.


EFFECT PARAMETERS MEASURED: The parent Daphnia magna were assessed visually daily for immobility and any other abnormalities in appearance
and behaviour. At study termination, the length of the adults was measured by digital photography and image analysis and their statistics compared
with those of the control animals. The newborn Daphnia magna in each beaker were counted at each daily renewal of the test solutions, inspected
for abnormalities in condition, and removed. The following endpoints observed in the reproduction test were evaluated quantitatively: - Mortality (immobility) of parental generation Daphnia magna - Age at first brood - Total number of offspring per replicate - Cumulative Number of live offspring per surviving female at the time of recording - Intrinsic rate of increase, r - Individual length of adults


RANGE-FINDING STUDY
The range finding studies used to determine test concentration are referenced as:
Schafers C (2005a): Pre-studies with dodecanol (C12 OH) for the preparation of a study plan for a Daphnia magna reproduction test (OECD 211). Fraunhofer IME, Schmallenberg, Germany.
Schafers C (2005a): Pre-studies with pentadecanol (C15 OH) for the preparation of a study plan for a Daphnia magna reproduction test (OECD 211). Fraunhofer IME, Schmallenberg, Germany.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

14 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

95 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: of parent Daphnia

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

10 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Duration:

21 d

Dose descriptor:

other: EC20

Effect conc.:

34 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Details on results:

- Mortality of parent animals: At the highest treatment level 6 out of 10 introduced animals died, 5 of them before reproduction, therefore the highest treatment was not considered in the evaluation of reproduction and growth.

- No. of offspring produced per day per female: for control, 3, 5, 14 and 95 µg/L was respectively: 3.2, 3.19, 3.07, 3.04 and 2.56 (see Table 1)

- Body length and weight of parent animals: The average growth length was (respective to nominal concentrations) control - 4.83 mm, 25 ug/L - 4.37 mm, 69 ug/L - 4.47 mm, 185 ug/L - 4.38 mm, 500 ug/L - 4.76 mm (see Table 1)

- Time to first brood release or time to hatch: the mean age at first brood was between 8.1 and 8.4 days for all relevant treatment levels (see Table 1)

- Brood size: for control, 3, 5, 14 and 95 µg/L the cumulative number of offspring per female was 68, 68, 63, 61 and 64 respectively (see Table 1)

Reported statistics and error estimates:

The evaluation of the concentration-effect-relationships and the calculations of effect concentrations were based on mean measured initial concentrations as multiple peak concentrations, as well as on geometric means between mean measured initial and aged (24h) test concentrations. For each endpoint, the NOEC, LOEC, and, if possible, the EC50, EC20 and EC10 were determined. A LOEC and NOEC were calculated by ANOVA followed by Williams' test or an appropriate non-parametric test suggested by the ToxRat program. When the test results showed a concentration-response relationship, the data were analysed by regression using Probit-analysis assuming log-normal distribution of the values using the computer program ToxRat program.

Table 1. Survival, growth and reproduction data.

 

Test item nominal conc. (ug/L)	Survival (%)	Growth (length) Mean ± SD (mm)	Age at first brood Mean ± SD (days)	Cumulative offspring per female Mean ± SD (#)	Age at first brood Mean ± SD (1/days)
Control	100	4.83 ± 0.35	8.2 ± 0.79	68.0 ± 8.9	0.320 ± 0.024
25	100	4.37 ± 0.39	8.2 ± 0.92	68.0 ± 11.6	0.319 ± 0.026
69	100	4.47 ± 0.31	8.4 ± 0.84	63.0 ± 9.8	0.307 ± 0.018
185	100	4.38 ± 0.41	8.1 ± 0.99	61.0 ± 7.1	0.304 ± 0.019
500	40	4.76 ± 0.40	8.6 ± 1.14	64.0 ± 19.3	0.256 ± 0.044

 

 

Table 2. Calculated statistics relative to initial concentrations.

 

EC10	150 µg test item/L
EC20	520 µg test item/L
LOEC	530 µg test item/L
NOEC	160 µg test item/L

 

Table 3. Nominal and measured concentrations.

 

 

Nominal concentration (ug/L)	Measured concentration - FRESH media (ug/L) (Mean (SD %))	Measured concentration - OLD media (ug/L) (Mean (SD %))	Geometric mean (ug/L)
25	20 (25%)	<LOQ (39%)	3.4
69	56 (21%)	<LOQ (5%)	5.3
185	163 (24%)	1.1 (100%)	13.6
500	534 (19%)	17 (135%)	95.3

Validity criteria fulfilled:

yes

Conclusions:

A reliable 21 day NOEC repro value of 14 ug/L was determined for the effects of the test substance on reproduction (cumulative number of offspring) of the freshwater test organism Daphnia magna.

Reference 4

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-08-22 to 2005-09-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

to allow aeration of the vessels, test media eas prepared daily, water changes occured daily, daphnia were carefully rinsed at each water change.

Principles of method if other than guideline:

Deviations from the guideline was as follows: due to the unavoidable biodegradation process caused by the presence of algae (daphnia feed), severe oxygen depletion occurred, cautious aeration with sterile filtered air was implemented in order to overcome this.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Pooled samples were taken at each concentration from vessels 1-5 and 6-10 for the measurement of the aged test solution.

- Sampling method: Freshly prepared test solutions aliquots (500 ml), obtained before distribution to the replicates, and aged test solutions aliquots (500 ml), obtained before the renewal on the next day of all test concentrations, were sampled three times a week.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method: The test solutions were prepared by stirring the test substance in test media under slow stir conditions (1 h) in sterilised mixing vessels. The mixing vessels were cylindrical brown glass bottles with teflon covered screw caps, fitted with a drain port near the bottom for drawing off the test solution. The volume of the mixing vessels was 2L. The loading of the mixing vessels corresponded to 24.4, 68.6, 185.2 and 500 ug/L and was targeted at achieving an initial top concentration of approximately 350 ug/L, taking into account 30% adsorption to the glassware as shown in pre-studies. For each concentration, an ethanoic stock solution was prepared. 1 ml of the appropriate ethanoic stock solution was pipetted into the 2 L mixing vessel taken from the sterilisation process, the still warm mixing vessel slowly turned to cover maximum area of the glass walls with ethanoic solution. The movements were continued until the liquid was no longer visible. The ethanol solution did not moisten the inner area of the flask where a sharp magnetic stirrer was later placed. After the addition of the stirring bar the vessels were sealed leaving only a small headspace. The contents of the vessels were stirred at 100 rpm for approximately 21 h. After stirring the contents of the vessels were left to settle for 2 h. The aqueous saturated phase was then taken out of the drain port. The first fraction (0-100 ml) was withdrawn. The fraction between 100 and 1800 ml was used for rinsing (200 ml) and filling (1000 ml) the test flasks for toxicity testing and for analytical measurements (500 ml), if done. Rinsing of the vessels was carried out to saturate the surfaces of the vessels. The test media were not stored for more than 1-2 h prior to testing.

- Controls: The control medium was prepared similarly as above with 1 ml of ethanol

- Chemical name of vehicle (organic solvent, emulsifier or dispersant): ethanol

- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): <1ml

- Evidence of undissolved material (e.g. precipitate, surface film, etc): the test solutions of fatty alcohols were not filtered as the filtration procedure was shown to cause highly variable concentrations of alcohols, and lower than the ones predicted by the physico-chemical model. When omitting the filtration procedure, the concentrations were clearly higher than the predicted solubility. This is thought by the authors of the report to be due to the fact that the measured concentrations comprised a fraction of dissolved test substance and a fraction of finely dispersed material. It was considered to be technically impossible to avoid the presence of very fine undissolved particles or droplets at the highest concentration.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Common name: freshwater flea or daphnia

- Source: Umweltbundesamt (German Federal Environment Agency)

- Age of parental stock (mean and range, SD): 4-24h old

- Feeding during test

- Food type: suspensions of unicellular green algae. The suspensions of Desmodesmus subspicatus ere analysed for microbial contamination. The content food in the test suspensions, measured as turbidity at 758 nmm, increased during the test from 7 mg C/L equivalents to 15 mg C/L equivalents.
- Frequency: daily, with the change of test solution.


ACCLIMATION

- Acclimation period: the organisms were bred at the testing facility. Adult daphnia (>3 weeks old) were separated from the stock population, and kept in batches of 30-50 animals in 1800 ml dilution water at room temperature for a week. Newborn daphnia were separated by sieving, the first generation was discarded.

- Acclimation conditions (same as test or not): same though kept at room temperature (temperature not recorded).

- Type and amount of food: algal suspension (Desmodesmus subspicatus) and LiquizellR (HOBBY). Algae growing in the log phase were centrifuged and re-suspended in a few ml of medium. 30 ml of this suspension was given to the 1L of daphnia medium.

- Feeding frequency: daily


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: newborn daphnia were separated by sieving.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Post exposure observation period:

none

Hardness:

0.7 mmol/L

Test temperature:

21 +/- 1 deg C

pH:

9.3-9.4

Dissolved oxygen:

>75% or >6 mg/L

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations: 0, 24.4, 68.6, 185.2, 500 ug test item/L.
Geometric means of mean measured initial and aged concentrations after 24h (effect concentration): 0, 1.6, 3.6, 13 and 77 ug test item/L.
Mean measured concentrations of fresh test solutions: Biodegradation caused the majority of the change in the fresh and aged test solution concentrations, followed by adsoprtion to the test vessels.

Details on test conditions:

TEST SYSTEM

- Test vessel: beakers

- Type (delete if not applicable): closed with an autoclaved silicone stopper

- Material, size, headspace, fill volume: glass beakers filled with 100 ml test medium

- Aeration: yes, with sterile filtrated synthetic air: the autoclaved silicone stoppers were fitted with fine glass capillaries connected to the aeration unit. The capillaries were introduced just below the surface of the test solutions.

- Renewal rate of test solution (frequency/flow rate): daily

- No. of organisms per vessel: 1

- No. of vessels per concentration (replicates): 10

- No. of vessels per control (replicates): 10


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: purified drinking water (filtered and autoclaved before use).

- Total organic carbon: DOC 0.62 mg/L

- Metals: Cu 0.0032 mg/L; Fe 0.0138 mg/L; Mn 0.0007 mg/L and Zn 0.0045 mg/L

- Alkalinity: 1.7 mml/L

- Ca/mg ratio: Ca 0.6 mmolL, Mg 0.1 mmol/L; ratio = 6:1

- Conductivity: 214 uS/cm

- Culture medium different from test medium: no

- Intervals of water quality measurement: daily


OTHER TEST CONDITIONS

- Photoperiod: light/dark cycle of 16/8 hours

- Light intensity: <1000 Lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : effects on growth (adult length at test termination), reproductive performance, immobility and any other abnormalities were investigated daily. The following endpoints were evaluated quantitavely:
- mortality (immobility) of parental generation of Daphnia magna
- age at first brood
- total number of offspring per replicate
- cumulative number of offspring per surviving female at the time of recording
- intrinsic rate of increase
- individual length of adults


VEHICLE CONTROL PERFORMED: ethanol was included in the control


RANGE-FINDING STUDY:

- Test concentrations: up to 500 ug/L (nominal)

- Results used to determine the conditions for the definitive study: highest nominal concentration of 500 ug/L chosen in order to achieve the highest measured concentration near the maximum estimation of water solubility.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1.6 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

3.6 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Duration:

21 d

Dose descriptor:

other: EC20

Effect conc.:

23 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

6.3 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: (cumulative number of offspring)

Details on results:

- Mortality of parent animals: at the highest treatment 3 of the 10 introduced daphnia died between days 9 and 16.

- No. of offspring produced per day per female: for control, 24.4, 68.6, 185.2, 500 ug/L respectively: 3.7, 3.6, 3.5, 3.4 and 3.4

- Body length and weight of parent animals: adult body length showed no significant difference between treatments.

- Time to first brood: the mean first brood occurred between 7.7. and 8.2 days at all concentrations, no statistically significant deviation from controls.

- Brood size: the cumulative number of offspring was significantly reduced by 8, 15 and 20% at the three higher treatments. The intrinsic rate of increase (r) was significantly reduced at the two higher concentrations, but by less than 10%.

- Effect concentrations exceeding solubility of substance in test medium: the test solutions of fatty alcohols were not filtered and the resulting concentrations were clearly higher than the predicted solubility.

Reported statistics and error estimates:

The LOEC and NOEC were calculated by ANOVA followed by William's test or an appropriate non-parametric test suggested bt the ToxRat program. When the results showed a dose-response relationship, the data were analysed by regression using Probit-analysis assuming log-normal distribution of the values using the program ToxRat.

Table 1: Effect of 1 -tetradecanol on growth and survival of D. magna

 

Treatment (ug/L)	Mortality of parents	Growth (length))	Age at first brood	Cumulative offspring per female	Intrinsic rate of increase r
	%	Mean ± SD (mm)	Mean± SD (days)	Mean± SD (#)	Mean ± SD (1/d)
Control *	0	4.47 ± 0.32	7.8± 0.8	86.6± 5.7	0.368± 0.0319
24.4	0	4.83± 0.31	7.7± 0.7	84.0± 7.4	0.364± 0.0343
68.6	0	4.50± 0.38	8.1± 0.7	79.7± 9.4	0.347± 0.0328
185.2	0	4.49± 0.27	8.2± 0.8	73.9± 8.5	0.338± 0.0347
500	30	4.73± 0.40	7.9± 0.6	70.4± 8.2	0.338± 0.0241

 

* thecontrol is also the solvent control (ethanol).

 

The daily transfer of daphnia, although rinsed thoroughly, did cause the re-introduction of bacteria, which increased in number with growth of carapace and resulted in more pronounced losses in the last two weeks of the reproduction studies.

 

Table 2: Nominal and measured concentrations for 21 days.

		Measured concentration (ug/L) results
Nominal concentration		24.4	68.8	185.2	500
Fresh media	Mean* ±st. dev. (%)	10 ± 49%	51 ± 21%	138 ± 20%	367 ± 31%
Old media	Mean* ±st. dev. (%)	<LOQ	<LOQ	1.2 ± 134%	16 ± 157%
Mean¥	% of nominal (ref. to mean)	1.6	3.6	12.7	76.7

* arithmetic mean of 3 weekly measurements

¥ geometric mean of fresh and old means

 

Table 3. Effect concentrations relative to daily initial concentrations (based on cumulative number of offspring).

 

Endpoint	ug test item/L
EC10	70
EC20	270
LOEC	51
NOEC	9.8

Validity criteria fulfilled:

yes

Conclusions:

A reliable 21 d NOECrepro value of 1.6 ug/L has been identified for the effect of the test substance on the cumulative number of offspring of D. magna.

Reference 5

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Qualifier:

according to guideline

Guideline:

other: UBA toxicity testing protocol 'Prolonged toxicity test with Daphnia Magna', 01.02.1984

Deviations:

no

Principles of method if other than guideline:

Method: Chronic toxicity testing in Daphnia magna according to UBA toxicity testing protocol 'Prolonged toxicity test with Daphnia Magna', 01.02.1984; determination of the NOEC for reproduction rate, mortality and the moment of the first appearance of descendants.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Concentrations: At concentrations 0, 10, 30 and 100 mg/L.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: test substance was weighed and added directly into test vessels

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Strain/clone: strain is identical with that of BGA.

- Source: own breeding

- Age of parental stock (mean and range, SD): 24 h

- Feeding during test

- Food type: 1 ml algae (1-3 * 10E6 cells/ml) and 1 ml activated sludge

- Frequency: Mon/Wed/Fri


ACCLIMATION

- Acclimation period: 1 day

- Acclimation conditions (same as test or not): not reported

- Health during acclimation (any mortality observed): not reported

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

19-23 C

pH:

range: 8.3-8.5

Dissolved oxygen:

range: 90-93%

Nominal and measured concentrations:

Nominal Loading rates: 0, 1, 3, 10, 30 and 100 mg/L.

Details on test conditions:

TEST SYSTEM

- Test vessel: Erlenmeyer flasks

- Material, size, headspace, fill volume: 500 ml flasks, filled with 200 ml test solution

- Aeration: not reported

- Renewal rate of test solution (frequency): Monday/Wednesday/Friday

- No. of organisms per vessel: 5

- No. of vessels per concentration (replicates): 4

- No. of vessels per control (replicates): 4



TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: aerated tap water

- Culture medium different from test medium: not reported

- Intervals of water quality measurement: temperature, DO and pH were recorded at each water renewal in the control, 3 and 100 mg/L concentrations.


OTHER TEST CONDITIONS

- Adjustment of pH: not reported

- Photoperiod: 16 hours light, 8 hours dark

- Light intensity: Radium 60W


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : reproduction rate and mortality determined on Mon/Wed/Fri.



RANGE-FINDING STUDY: no range finding study was conducted.

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.98 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: reproduction rate and mortality

Remarks on result:

other: non-toxic at the limit of solubility

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

2.94 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: reproduction rate and mortality

Remarks on result:

other: non-toxic at the limit of solubility

Details on results:

- Mortality of parent animals: increased with increasing concentration, see Table 1 for details.

- No. of offspring produced per day per female: not reported

- Body length and weight of parent animals: not reported

- Time to first brood release or time to hatch: the first time of appearance of young was on the 12th day of the study, on the 9th day no young were recorded. Given the spacing of checks, the young would have first appeared on days 9-12.

- Effect concentrations exceeding solubility of substance in test medium: all the concentrations tested were above the limit of solubility 0.0011 mg/L at 25 degC . The NOEC is also determined a a concentration higher than the limit of solubility.

Reported statistics and error estimates:

NOEC was determined via t-test.

Table 1: Effect of octadecanol on growth and survival of D. magna.

Nominal concentration (mg/L)		Mortality of parents (dead or immobile)		Survival rate (average)	Total no. of offspring	Offspring per adult (average)
		No Dead	%	%	#	Mean ± S.D.
Control	Replicate #1	1	475	90	475	106 ± 3.6
	Replicate #2	1	423		423
	Replicate #3	0	512		512
	Replicate #4	0	523		523
1	Replicate #1	2	398	90	398	101 ± 21.5
	Replicate #2	0	434		434
	Replicate #3	0	445		445
	Replicate #4	0	477		477
3	Replicate #1	0	390	70	390	81 ±   17.6
	Replicate #2	1	260		260
	Replicate #3	3	244		244
	Replicate #4	2	310		310
10	Replicate #1	1	256	70	256	56 ± 20.7
	Replicate #2	1	112		112
	Replicate #3	2	203		203
	Replicate #4	2	224		224
30	Replicate #1	1	284	60	284	56 ± 8.6
	Replicate #2	3	219		219
	Replicate #3	2	132		132
	Replicate #4	2	183		183
100	Replicate #1	1	232	55	232	45 ± 12.1
	Replicate #2	2	157		157
	Replicate #3	2	106		106
	Replicate #4	4	34		34

Mean measured (DOC) concentrations in the 10 mg/L group were 0.7, 1.15 and 1.95 mg/L at 0, 48 and 120 hours, respectively. Similar measured  concentrations were obtained in the 30 and 100 mg/L groups. From these measurements together with stable oxygen levels and the test substance being non-volatile the authors conclude that no biodegradation of the test substance did not occurred and therefore the test substance is present in the test medium at concentrations equivalent to the nominal concentration. It is the opinion of the reviewer that the DOC measurements did not vary greatly between increasing concentrations since a large fraction of the test material was not dispersed due to the low water solubility of the test substance.

The results above the limit of solubility should be treated with caution as they may reflect the effects of physical fouling rather than true toxicity of the test substance.

 

Validity criteria fulfilled:

yes

Conclusions:

A 21 NOEC of 0.98 mg/L has been determined for the effects of the test substance on reproduction rate and mortality of D. magna. The result is much higher than the limit of solubility of the test substance and should be treated with caution; the test substance did not appear to be toxic at the limit of solubility. Therefore the NOEC is >0.001 mg/L.

Reference 6

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

QSAR prediction: US EPA accepted QSAR method for chemicals properties assessment.

Qualifier:

according to guideline

Guideline:

other: QSAR

Principles of method if other than guideline:

EPI Suite v 4.0/ECOSARv1.00

GLP compliance:

no

Remarks:

not applicable to QSAR models

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

other: Mysid shrimp

Details on test organisms:

Scientific name: Americamysis bahia
Common name: Opossum shrimp, Mysid shrimp, Mysids

Test type:

other: QSAR model

Water media type:

saltwater

Limit test:

no

Total exposure duration:

30 d

Hardness:

not applicable. QSAR model

Test temperature:

not applicable. QSAR model

pH:

not applicable. QSAR model

Dissolved oxygen:

not applicable. QSAR model

Salinity:

not applicable. QSAR model

Details on test conditions:

CAS Number: 67762-27-0
SMILES : CCCCCCCCCCCCCCCCO
CHEM : Alcohols, C16-18
MOL FOR: C16 H34 O1
MOL WT : 242.45
Log Kow: 6.73 (KowWin estimate)
Wat Sol: 0.0412 mg/L (experimental database)

Reference substance (positive control):

no

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

0 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: non-toxic at the limit of solubility, as determined by (Q)SAR

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

0.092 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: non-toxic at the limit of solubility, as determined by (Q)SAR

Details on results:

A NOEC value of 0.00000924 mg/L has been calculated for the effects of the test substance on the mortality of the Mysid shrimp. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 0.0924 mg/L has been calculated for the effects of the test substance towards Mysid shrimp. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00000924 mg/L. Predicted to be non-toxic at the limit of solubility.

Overview of QSARs estimations on long-term aquatic toxicity of

Alcohols, C16-18

to Mysid shrimp

 

Method	Results	Remarks	Reference
QSAR estimate	Mysid Shrimp (SW), 30-day, ChV (chronic value) =  0.00000924 mg/L (ppm Mysid Shrimp, 96 -hr, LC50= 0.000435 mg/L (ppm)	Reliable with restrictions, QSAR estimated data	ECOSAR Program (v1.00)

 

Mysid Shrimp (SW), 30-day, ChV (chronic value) =  0.00000924 mg/L (ppm

Mysid Shrimp, 96 -hr, LC50= 0.000435 mg/L (ppm)

 

Validity criteria fulfilled:

yes

Remarks:

US EPA accepted QSAR method for chemicals properties assessment.

Conclusions:

A NOEC value of 0.00000924 mg/L has been calculated for the effects of the test substance on the mortality of the Mysid shrimp. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 0.0924 mg/L has been calculated for the effects of the test substance towards Mysid shrimp. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00000924 mg/L. Predicted to be non-toxic at the limit of solubility.

Executive summary:

A NOEC value of 0.00000924 mg/L has been calculated for the effects of the test substance on the mortality of the Mysid shrimp. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS. A reliable NOEC value of 0.0924 mg/L has been calculated for the effects of the test substance towards Mysid shrimp. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.00000924 mg/L. Predicted to be non-toxic at the limit of solubility.

Reference 7

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

(Q)SAR

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

QSAR prediction: US EPA accepted QSAR method for chemicals properties assessment.

Qualifier:

according to guideline

Guideline:

other: QSAR

Principles of method if other than guideline:

EPI Suite v 4.0/ECOSARv1.00

GLP compliance:

no

Remarks:

not applicable to QSAR models

Analytical monitoring:

not required

Vehicle:

not specified

Test organisms (species):

other: Daphnid species

Details on test organisms:

no further information

Test type:

other: QSAR model

Water media type:

freshwater

Limit test:

no

Total exposure duration:

30 d

Hardness:

not applicable. QSAR model

Test temperature:

not applicable. QSAR model

pH:

not applicable. QSAR model

Dissolved oxygen:

not applicable. QSAR model

Salinity:

not applicable. QSAR model

Details on test conditions:

CAS Number: 67762-27-0
SMILES : CCCCCCCCCCCCCCCCO
CHEM : Alcohols, C16-18
MOL FOR: C16 H34 O1
MOL WT : 242.45
Log Kow: 6.73 (KowWin estimate)
Wat Sol: 0.0412 mg/L (experimental database)

Reference substance (positive control):

no

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

0.04 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: non-toxic at the limit of solubility, as determined by (Q)SAR

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

400 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: (Q)SAR prediction

Remarks on result:

other: Predicted, at water solubility loading rates of 1000 mg/L

Details on results:

Daphnid, 30-day,NOEC for freshwater species cited as ChV (chronic value) = 0.04 mg/L (ppm).
A NOEC value of 0.04 mg/L has been calculated for the effects of the test substance on the mortality of the Daphnid. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 400 mg/L has been calculated for the effects of the test substance towards Daphnid. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.04 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Overview of QSARs estimations on long-term aquatic toxicity

of  Alcohols, C16-18 to Daphnid     

Method	Results	Remarks	Reference
QSAR estimate	Daphnid, 30-day, ChV (chronic value) = 0.04 mg/L (ppm)   Daphnid , 48-hr LC50 =   0.014 mg/L (ppm)	Reliable with restrictions, QSAR estimated data	ECOSAR Program (v1.00)

ECOSAR QSAR model predicts that NOEC for fresh water species Daphnid cited as ChV (chronic value) would to be 0.04mg/l. 

This result signifies that the test substance is not expected to be toxic at the limit of solubility.This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.

  

Daphnid, 30-day, ChV (chronic value) = 0.04 mg/L (ppm)

Daphnid , 48-hr LC50 =   0.014 mg/L (ppm)

Validity criteria fulfilled:

yes

Remarks:

US EPA accepted QSAR method for chemicals properties assessment.

Conclusions:

Daphnid, 30-day,NOEC for freshwater species cited as ChV (chronic value) = 0.04 mg/L (ppm).
A NOEC value of 0.04 mg/L has been calculated for the effects of the test substance on the mortality of the Daphnid. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.
A reliable NOEC value of 400 mg/L has been calculated for the effects of the test substance towards Daphnid. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.04 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Executive summary:

ECOSAR QSAR model predicts that NOEC for fresh water species Daphnid cited as ChV (chronic value) would to be 0.04 mg/l. 

This result signifies that the test substance is not expected to be toxic at the limit of solubility.This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS.

The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

Description of key information

Daphnid, 30-day,NOEC for freshwater species cited as  ChV (chronic value) = 0.04 mg/L (ppm).
A NOEC value of 0.04 mg/L has been calculated for the effects of the test substance on the mortality of the Daphnid. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and  NOEC is >LoS.
A reliable NOEC value of 400 mg/L has been calculated for the effects of the test substance towards Daphnid. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.04 mg/L. Predicted to be non-toxic at the limit of solubility.
The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.
A 21 NOEC of 0.98 mg/L has been determined for the effects of the test substance on reproduction rate and mortality of D. magna. The result is much higher than the limit of solubility of the test substance and should be treated with caution; the test substance did not appear to be toxic at the limit of solubility. Therefore the NOEC is >0.001 mg/L.
The available data for saltwater aquatic invertebrates are limited and to obtaine the value for PNECs for saltwaters is taken account a assesment factor 10 to extrapolate to LC50 following the “Guidance on Information Requirement and Chemical Safety Assessment R.10: Characterisation of dose [concentration]- response for environment”and “Table R.10-5 Assessment factors proposed for deriving PNEC water for saltwater for different data sets”, to account for the possibility that greater taxonomic diversity in the marine environment makes it likely that some marine taxa may be more sensitive than the most sensitive freshwater taxa

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

400 mg/L

Marine water invertebrates

Marine water invertebrates

Dose descriptor:

NOEC

Effect concentration:

40 mg/L

Additional information

Daphnid, 30-day,NOEC for freshwater species cited as ChV (chronic value) = 0.04 mg/L (ppm). A NOEC value of 0.04 mg/L has been calculated for the effects of the test substance on the mortality of the Daphnid. This result signifies that the test substance is not expected to be toxic at the limit of solubility. This result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and NOEC is >LoS. A reliable NOEC value of 400 mg/L has been calculated for the effects of the test substance towards Daphnid. Therefore the test substance has been predicted to be non toxic at the limit of solubility, so the NOEC is 0.04 mg/L. Predicted to be non-toxic at the limit of solubility. The water solubility of the Alcohols, C16-18 is 0.0412 mg/l at 25 degC (experimental database). This is about 10000 times the water solubility of the test substance.

A 21 NOEC of 0.98 mg/L has been determined for the effects of the test substance on reproduction rate and mortality of D. magna. The result is much higher than the limit of solubility of the test substance and should be treated with caution; the test substance did not appear to be toxic at the limit of solubility. Therefore the NOEC is >0.001 mg/L.

The available data for saltwater aquatic invertebrates are limited and to obtaine the value for PNECs for saltwaters is taken account a assesment factor 10 to extrapolate to LC50 following the “Guidance on Information Requirement and Chemical Safety Assessment R.10: Characterisation of dose [concentration]- response for environment”and “Table R.10-5 Assessment factors proposed for deriving PNEC water for saltwater for different data sets”, to account for the possibility that greater taxonomic diversity in the marine environment makes it likely that some marine taxa may be more sensitive than the most sensitive freshwater taxa