Neodecanoic acid, iron salt

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 - < 300 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

The 96-h LL50 of Versatic 10 to rainbow trout was >100 mg/L

Executive summary:

The toxicity of neo-decanoic acid to rainbow trout (Oncorhynchus mykiss) was studied for a 96 -h contact period based on mortality. The test concentrations were 30, 100, 300 and 1000 mg/L (nominal) and effects did not appear up to the concentration of 100 mg/L. Therefore, the 96-h LL₅₀ of neo-decanoic acid to rainbow trout was reported as >100 mg/L and <300 mg/L (measured concentrations). The information on neo-decanoic acid is used in a read-across approach for the assessment of the target substance neodecanoic acid, iron salt. The water solubility of neodecanoic acid, iron salt, is below the LL₅₀ concentration reported for neodecanoic acid. Therefore, it is safe to assume that neodecanoic acid, iron salt, will not exhibit toxic effects in the aquatic environment.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.83 mg/L

Nominal / measured:

nominal

Conc. based on:

element (total fraction)

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Remarks:

Poor documentation, validity cannot be assessed.

Conclusions:

LC50 (96 hr) was 0.83 mg Fe/L.

Executive summary:

The 96–hr-acute toxicity of iron to Cyprinus caprio was studied under semi-static conditions as reported by Alam & Maughan (1992) and cited according to OECD (2007) or Johnson et al. (2007).

  

Results Synopsis

Age: fry

Length: 6.9 cm

Test Type: semi-static

LC50: 0.83 mg Fe/L  

Endpoint(s) Effected:  Mortality

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

17 mg/L

Nominal / measured:

nominal

Conc. based on:

element (total fraction)

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Remarks:

Poor documentation, validity cannot be assessed.

Conclusions:

LC50 (96 hr) was 17 mg Fe/L at pH 6.0-7.1.

Executive summary:

The 96–hr-acute toxicity of iron to Oncorhynchus mykiss was studied by Mattock (2002) and cited according to OECD (2007).

  

Results Synopsis

LC50 at pH 6.0 -7.1: 17 mg Fe/L  

Endpoint(s) Effected:  Mortality

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 27.9 mg/L

Nominal / measured:

nominal

Conc. based on:

element (total fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: at pH 6.9-7.4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

element (total fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: at pH 4.1-7.1

Validity criteria fulfilled:

not specified

Remarks:

Poor documentation, validity cannot be assessed.

Conclusions:

LC50 (96 hr) was 13 mg/L at pH 4.1-7.1, and above 28 mg/L at pH 6.9-7.4.

Executive summary:

The 96-hr acute toxicity of iron toOncorhynchus mykisswas studied by Mattock (2002) and cited according to OECD (2007).

Results synopsis

LC50 at pH 4.1–7.1: 13 mg Fe/L  

LC50 at pH 6.9–7.4: 0.41 mg Fe/L  

Endpoint(s) effected:  Mortality

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Justification for type of information:

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Analytical monitoring:

yes

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.41 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: at pH 5.5

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.48 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: at pH 6.0

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.75 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Remarks on result:

other: at pH 7

Validity criteria fulfilled:

not specified

Remarks:

Poor documentation, validity cannot be assessed.

Conclusions:

LC50 (96 hr) was 0.41 mg/L at pH 5.5, 0.48 mg/L at pH 6.0 and 1.75 mg/L at pH 7.0.

Executive summary:

The 96–hr-acute toxicity of iron to Salvelinus fontinalis was studied under flow-through conditions as reported by Decker and Menendez (1974) and cited according to OECD (2007) or Johnson et al. (2007).

  

Results Synopsis

Age: 14 months

Test Type: flow-through

LC50 at pH 5.5: 0.41 mg Fe/L  

LC50 at pH 6.0: 0.48 mg Fe/L  

LC50 at pH 7.0: 1.75 mg Fe/L  

Endpoint(s) Effected:  Mortality

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Details on test conditions:

TEST SYSTEM
- Test vessel: 8.7 L aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume:5.0 L
- No. of organisms per vessel: A group of 7 fish was used without duplication.

TEST MEDIUM / WATER PARAMETERS
Dilution water source: Tap water passed through activated carbon and membrane filter (1 μm), hardness: 34 mg/L as CaCO3, alkalinity: 24 mg/L as CaCO3

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16/8 (light/dark)
- Light intensity: 890 – 1,030 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5
- Range finding study : not reported

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

46.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

See below "Any other information on resukts incl. tables"

Reported statistics and error estimates:

LC50 value and 95 % confidence limit were calculated by Probit method (EPA/600/4-85/13, 1985).

Sublethal observations / clinical signs:

Table 1. Cumulative mortality of Oryzias latipes

Nominal concentrations (mg/L)	Measured concentrations (mg/L)	Number of organisms tested	Cumulative number of dead fish
			24 hrs	48 hrs	72 hrs	96 hrs
Control	Control	7	0	0	0	0
10	11.7	7	0	0	0	0
15	16.5	7	0	0	0	0
24	24.0	7	0	0	0	0
39	34.4	7	0	0	0	0
63	62.6	7	0	0	1	6
100	99.2	7	2	4	7	7

Table 2. pH of test solutions

Nominal concentrations (mg/L)	Measured concentrations (mg/L)	0 hr	24 hrs	48 hrs	72 hrs	96 hrs
Control	Control	7.42	7.15	7.17	7.25	7.27
10	11.7	6.75	7	7.07	7.09	7.17
15	16.5	6.58	6.82	6.97	7.01	7.07
24	24.0	6.36	6.49	6.65	6.67	6.8
39	34.4	6.11	5.89	5.34	4.11	4.19
63	62.6	5.93	5.61	4.72	3.65	3.5
100	99.2	5.71	5.53	4.21	-	-

Table 3. The results of acute toxicity test with pH adjustment

Nominal concentrations (mg/L)	pH	Number of organisms tested	Cumulative number of dead fish
			24 hrs	48 hrs	72 hrs	96 hrs
100	3,5	5	5	5	5	5
100	4,0	5	0	0	0	0
100	4,5	5	0	0	0	0
100	5,0	5	0	0	0	0
100	5,5	5	0	0	0	0
100	6,0	5	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

Measured concentrations were 11.7, 16.5, 24.0, 34.4, 62.6 and 99.2 mg/L (nominal concentrations at 10, 15, 24, 39, 63 and 100 mg/L). The LC50 (96 hr) equals 46.6 mg/L with a 95 % confidence limit was 36.1 – 61.5 mg/L. LC50 value and 95 % confidence limit were calculated by Probit method (EPA/600/4-85/13, 1985).

Executive summary:

The 96–hr-acute toxicity of iron dichloride to Oryzias latipes was studied under static conditions according to OECD 203 (GLP). Oryzias latipes were exposed to control, and test substance at measured concentrations of 11.7, 16.5, 24.0, 34.4, 62.6 and 99.2 mg/L (nominal concentrations at 10, 15, 24, 39, 63 and 100 mg/L) for 96 hrs. Mortality was observed daily.  The 96 – hour LC50 with 95 % confidence limit was 36.1 – 61.5 mg/L. LC50 value and 95 % confidence limit were calculated by Probit method (EPA/600/4 -85/13, 1985). 

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with fish.  

  

Results Synopsis

Age: 4 months

Length: 2.9 ± 0.1 cm

Weight: 0.22 ± 0.03 g

Test Type: static

LC50:  46.6 mg FeCl₂/L  (equalling 20.5 mg Fe/L)

Endpoint(s) Effected:  Mortality

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Description of key information

The potential toxicity of neodecanoic acid, iron salt to fish is assessed via read-across from its corresponding acid neodecanoic acid and and the counter-ion iron.

In a valid 96-hr short-term toxicity study according to OECD 203 (Eadsforth et al., 1998), Oncorhynchus mykiss were exposed to neodecanoic acid at nominal concentrations of 0.0 (control) and 30, 100, 300 and 1000 mg/L under semi-static conditions. Effects were observed. The LL50 value, based on mortality, was > 100 mg/L (arithm. mean measured concentration). As the measured concentrations of neodecanoic acid are far above the water solubility of the target substance neodecanoic acid, iron salt, aquatic short-term toxicity against fish is considered unlikely.

The toxicity of soluble iron (III) salts to fish was determined in a series of 96-hr tests, which were carried out at pH values between 4.1 and 7.8 and published in existing reviews (Johnson et al. 2007, OECD 2007). The lowest LC50 (96-hr, Oryzias latipes) of 46.6 mg FeCl₂/L (corresponding to 20.5 mg Fe/L) was reported by Bae et al. (2005). Soluble iron as such is considered not to exert any systemic effects on fish in the tested concentration range of up to 100 mg/L in a neutralized solution.  

In conclusion, true, intrinsic toxicity of iron cations in aquatic test organisms cannot be determined in studies when the solubility of the dissolved ferric cation (as the ferrous form will readily be oxidized to ferric species) is exceeded. None of the experiments found effects at such low levels. Therefore, acute effects are most likely the results of physical processes (pH-effect; electrostatic effects).

Finally, neither neodecanoic acid nor soluble iron (III) salt, of which neodecanoic acid, iron salt, is composed, exhibit any mortality in fish up to maximally achievable water soluble concentrations of the target substance. This information is used in a read-across approach in the assessment of the target substance neodecanoid acid, iron salt. A key value (LC50) for chemical safety assessment hence cannot be identified.

Additional information

Substance	Source	Key result	Hazard
Neodecanoic acid CAS 26896-20-8	Study report, 1998	Species: Oncorhynchus mykiss LL50 (96 hrs) = > 100 - < 300 mg/L (nominal) > 85 and < 305 mg/L (measured)   Measured values correspond to > 280 and < 990 mg Neodecanoic acid, iron salt/L	No hazard identified.   Solubility of neodecanoic acid, iron salt is far below 85 mg/L
FeSO4	Decker and Menendez 1975	Salvelinus fontinalis: 96-hr LC 50 at pH 5.5: 0.41 mg Fe/L (corresponding to 4.181mg Neodecanoic acid, iron salt/L);   96-hr LC 50 at pH 6.0: 0.48 mg Fe/L (corresponding to 4.896mg Neodecanoic acid, iron salt/L);   96-hr LC 50 at pH 7.0: 1.75 mg Fe/L (corresponding to 17.85mg Neodecanoic acid, iron salt/L);	No hazard identified. True, intrinsic toxicity of iron kations in aerobic aquatic test organisms cannot be determined in studies when the solubility of the dissolved ferric kation (as the ferrous form will readily be oxidized to ferric species) is exceeded. None of the experiments found effects at such low levels.
FeSO4	Alam M.K., Maughan, O.E. 1992	Cyprinus carpio:   96-hr LC50: 0.83 mg Fe/L (corresponding to 8.47mg Neodecanoic acid, iron salt/L);
Fe2(SO4)3	Mattock 2002a	Oncorhynchus mykiss: 96-hr LC50 at pH 6.9-7.4: >28 mg Fe/L (corresponding to 286mg Neodecanoic acid, iron salt/L);   96-hr LC50 at pH 4.1-7.1 >13 mg Fe/L (corresponding to 133mg Neodecanoic acid, iron salt/L);
FeSO4.7H2O	Mattock 2002b	Oncorhynchus mykiss: 96-hr LC50 at pH 6.0-7.1: >16.6 mg Fe/L (corresponding to 169mg Neodecanoic acid, iron salt/L);
Iron dichloride CAS 7758-94-3	Bae et al., 2005. Risk assessment of Iron dichloride in OECD High Production Volume Chemicals Program. J. ENVIRON. TOXICOL. Vol. 20, No.4, 375~383 (2005)	Fish (Oryzias latipes):   LC50 (96h)= 46.6 FeCl2 mg/L ( corresponding to 20.5 mg Fe/L and 209.4 mg neodecanoic acid, iron salt/L) the observed effects were partially due to the pH changes. For fish, no mortality was observed up to 100 mg/l of iron dichloride in neutralised solutions

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.