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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Qualifier:
according to guideline
Guideline:
other: Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC0, LC50, LC100, 48-96h
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 50 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
other: LC90
Effect conc.:
ca. 100 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Remarks:
Since the test in parts is poorly reported the validity criteria cannot be assessed sufficiently. Nevertheless the test is considered as valid based on the data given.
Conclusions:
Within 96 hours no effect (LC0) on Brachydanio rerio was observed up to a concentration of >/= 50000 mg/l.
Executive summary:

Within 96 hours no effect (LC0) of diiron trioxide on Brachydanio rerio (new name: Danio rerio) was observed up to a concentration of >/= 50000 mg/L, and a 96-hour LC90 of about 100000 mg/L was obtained. The method used was a proposed procedure for lethal effect on Zebrabaerbling. (Federal Environmental Agency Germany May 1984).

The study was performed with concentrations of 10000 mg/L, 20000 mg/L, 50000 mg/L and 100000 mg/L in a static test. The report value related to nominal concentrations, as no analytical monitoring was carried out. Effect concentrations were calculated using the probit analysis.

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Principles of method if other than guideline:
Directive 92/69/EEC, C.1, equivalent to the OECD 203
GLP compliance:
yes
Analytical monitoring:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
other: LL 0 (= Lethal loading)
Effect conc.:
>= 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Remarks:
The mortality in the controls must not exceed 10% by the end of the test. The dissolved oxygen concentration must have been more than 60% of the air-saturation value troughout the study. The pH should not vary by more than 1 unit.
Conclusions:
For triiron tetraoxide a 96-hour LL0 (lethal loading) of >/= 10000 mg/L (nominal concentration) was observed on Brachydanio rerio.
Executive summary:

Directive 92/69/EEC, C.1, equivalent to the OECD 203 was the method used.

A group of 10 fish of the recommended size were exposed to a limit test concentration of nominally 10000 mg/L of test substance dissolved in water. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 2, 24, 48, and 96 h of exposure.

For triiron tetraoxide a 96-hour LL0 (lethal loading) of >/= 10000 mg/L (nominal concentration) was observed on Brachydanio rerio.

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Principles of method if other than guideline:
Method: other: Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC 0, LC50, LC100, 48-96h
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
other: LC80
Effect conc.:
ca. 13 333 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
20 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Qualifier:
according to guideline
Guideline:
other: Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC 0, LC50, LC100, 48-96h
Deviations:
no
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Mortality and behaviour
Validity criteria fulfilled:
not specified
Remarks:
Since the test is poorly reported the validity criteria cannot be assessed sufficiently. Nevertheless the test is considered as valid based on the data given.
Conclusions:
Mortality and behaviour of Brachydanio rerio were not affected by Bayferrox 303 T black during 96 h testing at a concentration of 100000 mg/L. The fish toxicity of manganese ferrite was determined according the guideline Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC0, LC50, LC100, 48-96h.
Executive summary:

Groups of ten fish were exposed to a test concentration of 10, 33.3, 50 and 100 g/L of Bayferrox 330 T schwarz. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 0, 24, 48, 72 and 96 h of exposure.

Mortality and behaviour of Brachydanio rerio were not affected by Bayferrox 303 T black during 96 h testing at a concentration of 100000 mg/L. The fish toxicity of manganese ferrite was determined according the guideline Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC0, LC50, LC100, 48-96h.

LC0 >/= 100000 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Qualifier:
according to guideline
Guideline:
other: Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC 0, LC50, LC100, 48-96h
Deviations:
no
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Remarks:
Mortality in control < 5%
Conclusions:
Within 96 hours no effect (LC0) on Brachydanio rerio was observed up to a concentration of >/= 10000 mg/L. The method used was a proposed procedure for lethal effect on Zebrabaerbling (Federal Environmental Agency Germany May 1984).
Executive summary:

The study was performed to assess the acute toxicity of diiron trioxide to Danio rerio under static conditions. The study was conducted in accordance with the UBA test protocol: Letale Wirkung beim Zebrabaerbling Brachydanio rerio, (LC 0, LC50, LC 100; 48 -96 h) Stand MAi 1984, which is comparable to the OECD Guideline for Testing of Chemicaks No. 203 "Fish, Acute Toxicity test".

Groups of ten fish were exposed to a test concentration of 0.01, 0.1, 1 and 10 g/L diiron trioxide. Observations were made on the numbers of dead fishand the incidence of sublethal effects after 0, 24, 48, 72 and 96 h of exposure. The test was conucted with 10 animals per test concentration and one control. No feeding was performed during the exposure period and the test sytsem was static. Up to 96 h the value for LC0 was >/= 10 g/L.

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Method: other: Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC 0, LC50, LC100, 48-96h
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
not specified
Remarks:
Since the test is poorly reported the validity criteria cannot be assessed sufficiently. Nevertheless the test is considered as valid based on the data given.
Conclusions:
For iron hydroxide oxide within 96 hours no effect (LC0) on Brachydanio rerio was observed up to a concentration of 100000 mg/l.
Executive summary:

For iron hydroxide oxide within 96 hours no effect (LC0) on Brachydanio rerio was observed up to a concentration of 100000 mg/L. The method used was a proposed procedure for lethal effect on Zebrabaerbling. (Federal Environmental Agency Germany May 1984), (Bayer AG 1989).

A group of 10 fish of the recommended size were exposed to a static test conditions of nominal concentartions of 10000, 20000, 50000, and 100000 mg/L of test substance dissolved in water. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 0, 24, 48, 72, and 96 h of exposure.

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with accepted scientific principles
Justification for type of information:
see attachment "Read-across justification-environ assessment-iron oxides" and “Endpoint-specific read-across justification for nano forms of iron oxide, 2021” attached in IUCLID section 13.
Qualifier:
according to guideline
Guideline:
other: Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC0, LC50, LC100, 48-96h
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 000 mg/L
Validity criteria fulfilled:
not specified
Remarks:
Since the test is poorly reported the validity criteria cannot be assessed sufficiently. Nevertheless the test is considered as valid based on the data given.
Conclusions:
On Brachydanio rerio (new name: Danio rerio) a 96 -hour LC0 was observed at a concentration of >/= 100000 mg/L. The fish toxicity of zinc ferrite was determined according the guideline Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC0, LC50, LC100, 48-96h.
Executive summary:

LC0 >/= 100000 mg/L.

Groups of ten fish were xeposed to a test concentration of 10, 33.3, 50 and 100 g/L of zinc ferrite. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 0, 24, 48, 72, and 96 h of exposure. The concentrations mentioned are nominal. No analytical monitoring was performed.

On Brachydanio rerio (new name: Danio rerio) a 96 -hour LC0 was observed at a concentration of >/= 100000 mg/L. The fish toxicity of zinc ferrite was determined according the guideline Proposed procedure by the Federal Environmental Agency (Umweltbundesamt) for lethal effect on Zebrabaerbling, (May 1984), LC0, LC50, LC100, 48-96h.

Description of key information

Applying read-across to micro- and nano-sized iron (hydr)oxides (see attachment "Read-across justification-environ assessment-iron oxides" in section 13), micro-sized iron (hydr)oxides are not considered acutely toxic to fish. Respective 96-h LC50 values for the toxicity of micro- and nano-sized iron (hydr)oxides to Danio rerio range from > 10,000 mg/L to > 100,000 mg/L, a concentration that is 1000-fold above the corresponding OECD test limit.

Key value for chemical safety assessment

Additional information

For micro- and nano-sized iron (hydr)oxides, seven reliable studies on short-term toxicity to fish are available. No acute toxicity was observed in fish exposed to micro- and nano-sized iron (hydr)oxide forms, and unbounded 96 h LC50 values of > 10 g/L were derived.

 

An unbounded 96 h LC50 value of > 50 g/L (nominal) was reported for the toxicity of micro-sized diiron trioxide to Brachydanio rerio (new name: Danio rerio) as no effects (LC0) were observed up to a concentration of >= 50 g/L, and a 96 h LC90 of about 100 g/L was obtained (Bruns, 1989). The method used was a proposed procedure for lethal effect on Zebrabaerbling (Federal Environmental Agency Germany, May 1984).

 

In two reliable studies investigating the acute toxicity of micro-sized triiron tetraoxide to Danio rerio (Caspers, 2000; Bayer AG, 1989), unbounded 96 h LC50 values of > 10 g/L (nominal) were derived as no effects (LC0) were observed up to a concentration of 10 g/L.

 

Further, an unbounded 96 h LC50 of > 100 g/L (nominal) was derived for micro-sized zinc ferrite brown spinel (Weyers, 1989) in an acute toxicity test with Danio rerio following a proposed procedure for lethal effect on Zebrabaerbling (Federal Environmental Agency Germany, May 1984). An unbounded 96 h LC50 of > 100 g/L was also derived for micro-sized manganese ferrite black spinel in a reliable study (Weyers, 1989) following the same procedure.

 

Acute toxicity of iron (hydr)oxide nanoforms was investigated in two reliable studies using nano-sized diiron trioxide (Weyers, 1985) and iron hydroxide oxide yellow (Weyers & Caspers, 1989). Acute toxicity of nano-alpha diiron trioxide was investigated under static conditions in accordance with the proposed procedure for lethal effect on Zebrabaerbling (Federal Environmental Agency Germany, May 1984) and an unbounded 96 h LC50 of > 10 g/L (nominal) was derived. For nano-alpha iron hydroxide oxide yellow within 96 hours no effects (LC0) on Danio rerio were observed up to a concentration of 100 g/L. The method used was a proposed procedure for lethal effect on Zebrabaerbling (Federal Environmental Agency Germany, May 1984).

 

Based on read-across to micro- and nano-sized iron (hydr)oxides (see attachment "Read-across justification-environ assessment-iron oxides" in section 13), available data indicate a low potential for acute aquatic toxicity of iron (hydr)oxides to fish (see table below). Acute toxicity of micro- and nano-sized iron (hydr)oxides to fish was not observed up to 100 g/L (Weyers, 1989; Weyers & Caspers, 1989), a concentration that is 1000-fold above the corresponding OECD test limit for acute toxicity.

 

Table: Acute aquatic toxicity of iron (hydr)oxides to fish.

Endpoint

Test species

Test results

Test material/form

Reliability: Reference

Short-term toxicity to fish

Danio rerio

LC50 (96h): > 50 g/L nominal

LC0 (96h): >= 50 g/L nominal

diiron trioxide / powder

RL2: Bruns, 1989

.

Danio rerio

LC50 (96h): > 10 g/L nominal

LC0 (96h): >= 10 g/L nominal

triiron tetraoxide / powder

RL2: Caspers, 2000

.

Danio rerio

LC50 (96h): > 10 g/L nominal

LC0 (96h): >= 10 g/L nominal

triiron tetraoxide /powder

RL2:Bayer AG, 1989

.

Danio rerio

LC50 (96h): > 100 g/L nominal

LC0 (96h): >= 100 g/L nominal

zinc ferrite brown spinel / powder

RL2: Weyers, 1989

.

Danio rerio

LC50 (96h): > 100 g/L nominal

LC0 (96h): >= 100 g/L nominal

manganese ferrite black spinel / powder

RL2: Weyers, 1989

.

Danio rerio

LC50 (96h): > 10 g/L nominal

LC0 (96h): >= 10 g/L nominal

diiron trioxide / nano, alpha

RL2: Weyers, 1985

.

Danio rerio

LC50 (96h): > 100 g/L nominal

LC0 (96h): >= 100 g/L nominal

iron hydroxide oxide yellow / nano, alpha

RL2: Weyers & Caspers, 1989