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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-03-04 to 1996-03-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline and compliant with GLP. No analytical monitoring was carried out.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Principles of method if other than guideline:
The protocol followed in the experiment also took into account the OECD guideline 23 for testing difficult substances and mixtures (2000)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method: An amount of test material (40 mg) was dissolved in tetrahydrofuran with the aid of ultrasonic disruption and the volume adjusted to 10 ml. An aliquot (2.0 ml) of this solution was dispersed in 20L of dechlorinated tap water to give the concentration of 0.4 mg/L.

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

- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 2 ml in 20 L, the solvent control group was exposed to 100 ul/L of solvent control.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM

- Common name: rainbow trout

- Strain: Oncorhynchus mykiss

- Source: Donnington fish Farm, Upper Swell, Gloucestershire, UK

- Length at study initiation (length definition, mean, range and SD): 4.5 cm (SD = 0.2)

- Weight at study initiation (mean and range, SD): 1.2 g (SD = 0.26)

- Feeding during test: no the animals were starved from 24 h prior to the study initiation


ACCLIMATION

- Acclimation period: 7 days

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

- Type and amount of food: commercial trout pellets

- Health during acclimation (any mortality observed): 2% mortality
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none reported
Hardness:
136 CaCO3 mg/L
Test temperature:
14 degC
pH:
range: 7.4-7.9
Dissolved oxygen:
greater or equal to 9.3 mg O2/L
Salinity:
Not Applicable
Nominal and measured concentrations:
Nominal concentrations: 0.4 mg/L
Details on test conditions:
TEST SYSTEM

- Test vessel:

- Type (delete if not applicable): covered

- Material, size, headspace, fill volume: 20 L glass tanks

- Aeration: yes, via narrow bore glass tube

- Renewal rate of test solution (frequency/flow rate): 24 hours

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 2

- No. of vessels per control (replicates): 1

- No. of vessels per vehicle control (replicates): 1


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: dechlorinated tap water

- Alkalinity: 80 mg/L

- Conductivity: 405 uS/cm

- Culture medium different from test medium: no

- Intervals of water quality measurement: daily


OTHER TEST CONDITIONS

- Photoperiod: 8 h dark, 16 h light


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects were recorded at 3, 6, 24, 48 and 96 hours.


TEST CONCENTRATIONS

- Justification for using less concentrations than requested by guideline: the test substance was tested up to the limit of solubility.

- Range finding study

- Test concentrations: 0.1 and 1.0 mg/L

- Results used to determine the conditions for the definitive study: 96h EC50 >1.0 mg/L
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 0.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: non-toxic at the limit of solubility
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: non-toxic at the limit of solubility
Details on results:
- Mortality of control: 0%

- Effect concentrations exceeding solubility of substance in test medium: the test was conducted above the limit of solubility of the test substance, with the employment of the solvent tetrahydrofuran. The presence of undissolved material was not reported.
Reported statistics and error estimates:
Statistical analysis was not required.
Sublethal observations / clinical signs:

No mortalities (0%) were observed in the control, solvent control and 1.0 mg/L groups after 96 h. Therefore the LC50 could not be determined. The water solubility of the test substance is 0.013 mg/l at 25 degC [Yalkowsky et al, 1992]. Therefore the test substance was non-toxic at the limit of solubility.

Validity criteria fulfilled:
yes
Conclusions:
A 96 h LC50 >0.4 mg/L has been determined for the effects of hexadecanol on the mortality of the freshwater fish O. mykiss. However this result is above the LoS (limit of solubility), therefore the substance is non-toxic at the limit of LoS and LC50 is >LoS.
Endpoint:
short-term toxicity to fish
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Remarks:
The value was predicted using a validated (Q)SAR
Justification for type of information:
Please refer to attached justification documents
Qualifier:
according to guideline
Guideline:
other: Fisk et al. 2009
Deviations:
no
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
no data
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
based on OECD guideline requirements, however this is not an experimental data
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.01 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
Sublethal observations / clinical signs:

Predicted to be non-toxic at the limit of solubility.

Validity criteria fulfilled:
not applicable
Conclusions:
A 96 h LC50 value of >0.01 mg/L has been calculated for the effects of the test substance on the mortality of the fish taxonomic group. This result signifies that the test substance is not expected to be toxic at the limit of solubility.

Description of key information

LC50 (96 h): >0.4 mg/l (nominal) in accordance with test guideline OECD 203, for effects of hexadecan-1-ol (C16, CAS 36653-82-4) on mortality of the freshwater fish Oncorhynchus mykiss (Safepharm, 1996c).

Key value for chemical safety assessment

Additional information

A reliable 96 hour LC50 value of >0.4 mg/l has been determined for the effects of hexadecan-1-ol (C16, CAS 36653-82-4) on mortality of the freshwater fish Oncorhynchus mykiss (Safepharm, 1996c) in accordance with test guideline OECD 203. The water solubility of C16 is 0.024 mg/L, therefore C16 can be considered non-toxic at the Limit of Solubility (LoS) and the LC50 value can be said to be >0.024 mg/L (>LoS).

 

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

Linear LCAAs

The data summarised in the table below show that the toxicity of the single carbon number chain length LCAAs increases from an LC50 of 97 mg/L for C6 to 1.0 mg/L for C12. At higher carbon number chain lengths there is an absence of short-term toxicity (LC50 values are reported as being greater than the highest test concentration or higher than the water solubility of the test substance) and this is explained by the water solubility of an LCAA limiting its bioavailability, such that a toxic concentration for short-term exposure is not achieved.

The results of a 7-day, semi-static toxicity test with 1-octanol using Pimephales promelas larvae aged 1, 4 and 7 days at the start of the study have also been reported by (Pickering et al., 1996) but are not included in the table. NOECs based on nominal concentrations were 1.5-11.9 mg/L for survival. Measured concentrations in the test were reduced to non-detectable levels in most test vessels in the old media. The poor maintenance of exposure concentrations means that the reported NOEC values are almost certainly underestimates of the true toxicity of the substance. The results of this test are also discussed later with respect to long-term toxicity.

The lowest reliable LC50 values determined in tests with single carbon chain length LCAAs are shown in the following table. 


Table: Key fish short-term toxicity studies on single carbon chain length linear LCAAs.

CAS

Chemical Name

Comments

Water solubility (mg/L)

Species

Method/ Guideline

Exposure regime

Endpoint

Value (mg/L)1,2

Reliability code

Reference

111-27-3

1-Hexanol

 

5900 at 20°C

Pimephales promelas

US EPA 1975

Flow-through

96 h LC50

97 (m)

2

Veith, Call and Brooke, 1983a,b

111-70-6

1-Heptanol

Supporting

1300 at 20°C

Pimephales promelas

ASTM 1980

Flow-through

96 h LC50

38 (m)

2

Broderius and Kahl, 1985

111-87-5

1-Octanol

 

550 at 25°C 

Pimephales promelas

ASTM 1980

Flow-through

96 h LC50

13 (m)

2

Veith, Call and Brooke, 1983a,b; University of Wisconsin-Superior., 1984; Broderius and Kahl, 1985

143-08-8

1-Nonanol

 

130 at 20 °C

Pimephales promelas

ASTM 1980

Flow-through

96 h LC50

5.5 (m)

2

Broderius and Kahl, 1985

112-30-1

1-Decanol

 

40

Pimephales promelas

(embryo)

OECD TG 236

Flow-through

120 h LC50

3.4 (m)

1

Wildlife International, 2015b

112-30-1

1-Decanol

 

40

Pimephales promelas

US EPA 1975

Flow-through

96 h LC50

2.3 (m)

2

Veith, Call and Brooke, 1983a,b; Brooke et al., 1984

112-42-5

1-Undecanol

 

8.0 at 20°C

Pimephales promelas

US EPA 1975

Flow-through

96 h LC50

1.0 (m)

2

Veith, Call and Brooke, 1983a,b

112-53-8

1-Dodecanol

 

1.9 at 20°C

Pimephales promelas

US EPA 1975

Flow-through

96 h LC50

1.0 (m)

2

Veith, Call and Brooke, 1983a,b

112-70-9

1-Tridecanol

Supporting

0.38 at 20°C

Pimephales promelas

US EPA 1975

Flow-through

96 h LC50

>0.33 (m)

2

Veith, Call and Brooke, 1983a,b

112-72-1

1-Tetradecanol

 

0.19 at 25°C

Salmo gairdneri i3

OECD 203

Semi-static

96 h LC50

>1 (n) (>LoS)

2

SafePharm, 1996b

36653-82-4

1-Hexadecanol

 

0.024 at 25°C

Salmo gairdneri3

OECD 203

Semi-static

96 h LC50

>0.4 (n) (>LoS)

2

SafePharm, 1996c

112-92-5

1-Octadecanol

 

0.0011 at 25°C

Salmo gairdneri3

OECD 203

Semi-static

96 h LC50

>0.4 (n) (>LoS)

2

SafePharm, 1996d

661-19-8

1-Docosanol

 

approx. 0.001 (estimate)

Oncorhynchus mykiss

OECD 203

Semi-static

96 h LC50

>1000 (n)
(>LoS)

2

SafePharm, 2000

Notes:

1 >LoS: concentration/Loading rate greater than the limit of water solubility

2 (n) based on nominal concentrations, (m) based on measured concentrations.

3 Now known as Oncorhynchus mykiss. The names used in the study reports are given here.

Multi-constituent LCAAs

The data for multi-constituent substances of different carbon chain length LCAAs (commercial products) are shown in the table below. The results show that substances containing LCAAs with carbon numbers in the ranges of C8-10 and C6-12 exert short-term toxic effects at concentrations of between 0.7 and 10 mg/L. At these concentrations, all the constituents are likely to have been fully dissolved.

In contrast, multi-constituent substances - Alcohols, C12-13; Alcohols, C12-13-branched and linear and Alcohols, C12-15-branched and linear - exhibited effects at loading rates where not all constituents were fully dissolved. Under such circumstances the presence of retained undissolved test material, such as occurred in the Shell Toxicology Laboratory (1978a) test, opens up the possibility for physical fouling of the test organism and this needs to be kept in mind when interpreting the result. The multi-constituent substances containing LCAAs with carbon chain length C12 and above did not exhibit short-term toxicity effects at loading rates where the solubility of the constituent LCAAs was exceeded.

The data for nonanol, branched and linear, decanol branched and linear, decanol branched and undecanol branched alcohols, have been read-across from their linear alcohols counterparts (C9, C10 and C11) since they are essentially linear alcohols.

Alcohols, C14-15 ecotoxicity assessment is based on weight of evidence from two studies; Shell Internationale Chemie (1973) and Shell Toxicology Lab (1978a). Both studies report the LC50 to be above the limit of solubility. The Shell Internationale Chemie (1973) study tested the toxicity of the substance via the WAF preparation method (the preferred method of testing with poorly soluble mixtures) however it does not report complete information on the study methods and conditions. The Shell Toxicology Lab (1978a) did not utilise WAF methods but it is reported more comprehensively.

The results for both single carbon number LCAAs and the multi-constituent substances indicate that, for fish, there is a short-term toxicity cut-off for LCAAs with carbon numbers >C14.  

The lowest reliable LC50 values determined in tests with multiconstituent carbon chain length LCAAs are shown in the following table.


Table: Fish short-term toxicity studies on mixed carbon chain length LCAAs.

CAS #

Chemical name

Comments1

Water solubility (mg/L)

Species

Method/ Guideline2

Exposure regime

Endpoint

Value (mg/L)3

Reliability code

Reference

n/a

Alcohols, C7-9

 

510 at a loading rate of 1000 mg/L (estimated)

I. idus4

Not specified

Static

96 h LC50

0.7-0.8 (n)

2

Shell, 1978

67762-41-8

Alcohols, C8-10

Type C

SUPPORTING

2.4 at 25°C

Salmo gairdneri4 and Lepomis macrochirus

EPA 1975

Static

96 h LC50

6.5-10 (n)

2

EG&G Bionomics, 1975

n/a

Alcohols, C9-11- branched and linear

 Also valid for Alcohols, C9-11 CAS 66455-17-2

44 at a loading rate of 1000 mg/L. (estimated)

S. gairdneri4

Not specified

Static

96 h LC50

6.3-10 (n)

2

Shell Toxicology Laboratory, 1979

n/a

Alcohols, C9-11- branched and linear

 Also valid for Alcohols, C9-11 CAS 66455-17-2

44 at a loading rate of 1000 mg/L. (estimated)

Scopthalmus maximus (marine species)

Not specified

Semi-static

96 h LC50

5.8 (n)

2

Huntingdon Life Sciences Ltd., 1991d

68515-81-1

Nonanol, branched and linear

 

121 (estimated)

Pimephales promelas

ASTM 1980

Flow-through

96 h LC50

5.5 (m)

 

(r-a from C9)

2

Broderius and Kahl, 1985

90342-32-8

Decanol, branched and linear

 

26.17 at 20°C

P. promelas

US EPA 1975

Flow-through

96 h LC50

2.3 (m)

 

(r-a from C10)

2

Veith, Call and Brooke, 1983a,b; University of Wisconsin-Superior, 1984

128973-77-3

Undecanol, branched and linear.

Reaction mass of 2-methyldecan-1-ol and 2-propyloctan-1-ol and 2-ethylnonan-1-ol and 2-butylheptan-1-ol

 

6.3 at 25°C

P. promelas

US EPA 1975

Flow-through

 96 h LC50

1.0 (m)

(r-a from C11)

2

Veith, Call and Brooke, 1983a,b

75782-87-5

Alcohols, C12-13

 

2.4 at 25oC

S. gairdneri4

Not specified

Static

96 h LC50

4.0-10 (>LoS)

2

Shell Toxicology Laboratory, 1978a

75782-87-5

Alcohols, C12-13

 

2.4 at 25oC

S. maximus (marine species)

Not specified

Semi-static

96 h LC50

10 (n) (>LoS)

2

Huntingdon Life Sciences Ltd., 1991c

740817-83-8

Alcohols, C12-13-branched and linear

 

2.9-3.1 at 20°C

Brachydanio rerio

OECD 203 WAF

Semi-static

96-hr LL50

15 (n) (>LoS)

1

TNO, 2000a

90604-40-3

Alcohols, C12-15-branched and linear

 

0.80 at 20°C

Oncorhynchus mykiss

OECD 203 WAF

Semi-Static

96 h LL50

100-300 (n) (>LoS)

1

Shell Global Solutions, 2000

68855-56-1

Alcohols, C 12-16

Type B

SUPPORTING

0.80 at 20°C

O. mykiss

Not specified

Static

96 h LC50

57 (n) (>LoS)

2

Huntingdon Life Sciences 1996i

80206-82-2

Alcohols, C 12-14

not possible to determine compositional type

SUPPORTING

approx. 4 predicted at 1000 mg/L loading rate

L. idus

OECD 203

Static

48 h LC50

>5000 (n) (>LoS)

2

Henkel, 1999m

75782-87-5

Alcohols, C14-15

 

0.7 at 20°C and 0.15 at a loading rate of 1000 mg/L. (estimated)

S. gairdneri4

Not specified

Static

96 h LL50

>500 (n) (>LoS)

2

Shell Toxicology Lab 1978b

75782-87-5

Alcohols, C14-15

 

0.7 at 20°C and 0.15 at a loading rate of 1000 mg/L. (estimated)

Carassius auratus

Not specified

Static

96 h LL50

>0.7 (n)

(>LoS)

2

Shell Internationale Chemie, 1973

68002-94-8

Alcohols, C 16-18 and 18 Unsaturated 

SUPPORTING

0.0404 predicted at 1000 mg/L loading rate

L. idus

OECD 203

Static

48 h LC50

>10000 (>LoS)

4

Henkel, 1999o

Notes:

1 Compositional Types are described in section 1.4.7 of the category report.

2 WAF denotes test medium was a water-accommodated fraction.      

3 >LoS: LC50 observed was greater than the limit of solubility of at least some constituents of the substance.

4 Now known as Oncorhynchus mykiss. The names used in the study reports are given here.

(n) based on nominal concentrations.

(m) based on measured concentrations.

 


References:

Broderius, S. and Kahl, M., 1985. Acute toxicity of organic chemical mixtures to the fathead minnow. Aquatic Toxicology 6:307-322.

E.G.& G. Bionomics, 1975. Acute toxicity of two Conoco compounds to bluegill (lepomis macrochirus) and rainbow trout (Salmo gairdneri). Bioassay report submitted to Conoco Chemicals, Ponca City, Oklahoma.

Henkel KGaA, 1999m. Biological research and Product Safety/Ecology: Unpublished results; test substance registration No. 6801.

Henkel KGaA, 1999o. Biological Research and Product safety/Ecology: unpublished results, test substance registration no. 6802.

Huntingdon Life Sciences Ltd. (HLS), 1991d. Report No. SLL 207(d)/911034.

Huntingdon Life Sciences Ltd. (HLS), 1991c. Report No. SLL 207(c)/911033.

Huntingdon Life Sciences Ltd. (HLS), 1996i. Report No. 96/KAS231/0417.

SafePharm Laboratories, 1996b. SafePharm Laboratories SPL Project Number 140/599.

SafePharm Laboratories, 1996c. SafePharm Laboratories SPL Project Number 140/500.

SafePharm Laboratories, 1996d. SafePharm Laboratories SPL Project Number 140/506.

SafePharm Laboratories, 2000. SafePharm Laboratories SPL Project Number 140/1001.

Shell, 1978. The acute toxicity of Linevol 79 to the golden orfe (idus idus melanotus), Shell Group Research Report, TLGR.0024.78.

Shell Global Solutions, 2000. Shell Global Solutions Report CT.99.47088.

Shell Internationale Chemie, 1973. Determination of acute toxicity to fish of Shell chemicals. I. AMGR.0095.73. Shell Toxicology Laboratory, 1978a. GRR-TLGR.0161.78.

Shell Toxicology Laboratory, 1978b. GRR-TLGR.0162.78.

Shell Toxicology Laboratory, 1979. GRR-TLGR.0166.78.

TNO Nutrition and Food Research Institute, 2000a. Semi-static acute toxicity test with Compound 33A and the zebra fish Brachydanio rerio. TNO report V98.1319. University of Wisconsin-Superior, 1984. Acute Toxicities of Organic Chemicals to Fathead Minnows (Pimephales promelas). Center for Lake Superior Environmental Studies, University of Wisconsin-Superior.

Veith, G.D., Call, D.J., and Brooke, L.T., 1983a. Estimating the acute toxicity of narcotic chemicals to fathead minnows. In: Bishop, W.E., Cardwell, R.D., and Heidolph, B.B. (eds.). Aquatic Toxicology and Hazard Assessment: Sixth Symposium. ASTM STP 802. American Society for Testing and Materials, Philadelphia.

Veith, G.D., Call, D.J., and Brooke, L.T., 1983b. Structure-toxicity relationships for the fathead minnow, Pimephales promelas: Narcotic industrial chemicals. Can. J. Fish. Aquat. Sci. 40:743-748.

Wildlife International, 2015b. Decanol: A static-renewal fish embryo acute toxicity (FET) test with the fathead minnow (Pimephales promelas) Draft Report; Wildlife International Project Number: 774A-101; OECD Guideline 236.