Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts

Endpoint summary

Description of key information

The LD50 values derived from the acute oral toxicity studies with the analogues substances Fe(3K)EDDHSA and Fe(Na)EDDHA were > 2000 mg/kg bw. The dermal LD50 of > 2000 mg/kg bw is established for both read-across substances, too. The inhalation (4h) LC50 is > 4200 mg/m³ air (maximum attainable concentration) is established for Fe(Na)EDDHA in a limit test. Based on these results, the target substance Fe(3Na)EDDHSA is considered to be not acutely toxic by all routes of exposure and does not need to be classified and labelled according to CLP.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

from 2000-07- 27 to 2000-08-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, 69210 LArbresle, France.
- Age at study initiation: 6 weeks old
- Weight at study initiation: 172 ± 4 g for the males and 139 ± 3 g for the females
- Fasting period before study: The animals were fasted for an overnight period of approximately 18 hours before dosing, but had free access to water. Food was given back approximately 4 hours after administration of the test substance.
- Housing: in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period. Each cage contained dust-free sawdust (SICSA, 94142 Alfortville, France).
- Diet (e.g. ad libitum): ad libitum, except prior dosing (see above). A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2000-07- 27 To: 2000-08-15

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

purified (by reverse osmosis)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not reported: "The test substance was prepared at the chosen concentration in the vehicle. The test substance preparation was made freshly..."
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: "The volume administered to each animal was adjusted according to body weight determined on the day of treatment".

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As the test substance was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by administering 2000 mg/kg of the test substance to one group of three males. As no deaths occurred, the study was completed by the administration of the dose-level of 2000 mg/kg to one group of three females.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

other: the data on historical control rats were used

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day. Type, time of onset and duration of clinical signs were recorded for each animal individually.
The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of test facility's control animals with the same initial body weight.
- Necropsy of survivors performed: yes. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin. No microscopic examination was performed.
- Other examinations performed: no

Statistics:

The LD50 (median lethal dose) is the statistically derived single dose of the test substance that can be expected to cause death in 50% of the animals.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of toxicity

Mortality:

No deaths were observed during the study

Clinical signs:

other: No clinical signs were observed during the study

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities

Other findings:

No other findings

Table 1: Individual clinical signs and mortality

Dose (mg/kg)	Time	Animals		Mortality	Clinical signs
		Males	Females
2000	30 min - 1 h	01-02-03	04-05-06	No	None
	2h	01-02-03		No	None
	2h30		04-05-06	No	None
	4h00	01-02-03	04-05-06	No	None
	D2toD 15	01-02-03	04-05-06	No	None
min: minutes h: hour D: day

Table 2: Individual and mean body weight and weekly body weight change of treated rats (g)

Dose mg/kg	Volume		Animals	Days
		Sex
	ml/kg			1	(1)	8	(1)	15
2000	10	Male	01	176	79	255	45	300
			02	171	71	242	53	295
			03	168	86	254	76	330
			M	172	79	250	58	308
			SD	4	8	7	16	19
2000	10	Female	04	141	53	194	31	225
			05	136	60	196	23	219
			06	140	45	185	31	216
			M	139	53	192	28	220
			SD	3	8	6	5	5
(1)  = Body weight gain
M   = Mean
SD  = Standard Deviation

Table 3: Individual macroscopic examinations at necropsy

Dose mg/kg	Time	Animals		Macroscopic abnormalities
		Males	Females
2000	D 15	01-02-03	04-05-06	No apparent abnormalities
D: day

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the oral LD5o of the test substance EDDHAS Fe 3K is higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose level.

Executive summary:

The acute oral toxicity of the test substance Fe3KEDDHSA was evaluated in rats according to the "Acute Toxic Class Method". The study was conducted in compliance with the OECD TG 423. The test substance was prepared in purified water and was administered by oral route (gavage), with a volume of 10 mL/kg, to groups of fasted Sprague-Dawley rats. As the test substance was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by administering 2000 mg/kg of the test substance to one group of three males. As no deaths occurred, the study was completed by the administration of the dose-level of 2000 mg/kg to one group of three females. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test substance. All animals were subjected to necropsy.

No clinical signs and no mortality were observed in the animals given 2000 mg/kg. The overall body weight gain of the animals was not affected by treatment with the test substance. At necropsy, no apparent abnormalities were observed. Under the experimental conditions of this study, the oral LD50 of the test substance EDDHAS Fe 3K is higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose-level.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

There is no deficiencies in the available data set. The data on structurally related substances is reliable and consisitent.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

1994-01-20 to 1994-02-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Aimal Production, 4332 Stein/ Switzerland
- Age at study initiation: Young adult
- Weight at study initiation: 191 to 231 g
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: The animal were housed in Macrolon cages type 4, with standardized soft wood bedding; the animals, segregated by sex, were group-housed (5 animals per cage)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau /SG, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degree C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose only exposure system developed by Battelle Reasarch Centre (Geneva/Switzerland) and built from stainless steel by Ciba-Geigy Engineering Dept.
- Exposure chamber volume: internal active volume less than one liter
- Method of holding animals in test chamber: The rats were placed in Macrolon animal holders (Battelle Research Centres, Geneva/Switzerland) positioned radially around the exposure chamber, so that only the snouts and nostrils of the animals were exposed to the aerosol.
- Source and rate of air: The low in any individual aerosol delivery tube was standardized to 2 L/min (velocity 1.25 m/s)
- System of generating particulates/aerosols: the aerosol was generated from the solid test material by means of a brush-feed micronising jet mill. The aerosol generation system consists of a dual flexible-brush dust-feed mechanism, modified from a design by Milliman, and jet mill, redesigned from a commercial Trost Jet Mill, to be aerodynamically compatible with the brush feed and the exposure system.
- Method of particle size determination: Particle size analysis was conducted using an eight-stage cascade impactor, equiped with collection substrates punched from regenerated cellulose filters by Schleicher u. Schuell AG. Samples of 1 liter were passed through the impactor. The amount of particles in the eight size classes was determined gravimetrically.
- Treatment of exhaust air: In order to avoid rebreathing of the exhaled air, "fresh" test substance (in first-pass chamber air) was supplied to each animal via individual delivery and exhaust tubes. In addition to the necessary animal and sampling ports, identical "void" outlets were opened in proportion to the total air flow through the chamber. The exhaust air was decontaminated by subsequent passage through a Pall HDC absolute filter.


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The continuity of the particle size distribution was verified by repeated analysis of the aerosol using an APS-33 Aerodynamic Particle Sizer, equipped with appropriate dilution system to avoid coincidence counts. The number distribution in 48 classes was converted to a mass distribution, based on the bulk density of the test substance, which was determined separately.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The continuity of the particle size distribution was verified by repeated analysis of the aerosol using an APS-33 Aerodynamic Particle Sizer, equipped with appropriate dilution systems to avoid coincidence counts.

Duration of exposure:

4 h

Concentrations:

4202 +/- 188 mg/m³ air

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- clicnical symptoms and mortalities: during and after the exposure, as well as daily thereafter for 14 days
- body weight: immediately prior to exposure and on days 7 and 14 of the observation period
- Necropsy of survivors performed: yes

Statistics:

Not performed

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4 200 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortalities occured upon exposure to the test item at a concentration of 4202 +/- 188 mg/m³.

Clinical signs:

other: The animals of both sexes exposed to the test article experienced the symptoms piloerection and dyspnea to a similar extent. They recovered within 5 days.

Body weight:

The weight development of all animals was within normal limits.

Gross pathology:

No deviations from normal morphology could be detected in all animals.

No other information

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 of FeNaEDDHA in albino rats was found to be greater than 4200 mg/m³ air.

Executive summary:

The acute inhalation toxicity of FeNaEDDHA in albino rats was determined according to the OECD Guideline 403 (Acute Inhalation Toxicity). Upon a four-hour acute inhalation exposure and a 14-days post-treatment observation period, no mortalities were elicited by the test item at a concentration of 4202 +/- 188 mg/m³. Due to the properties of the test material, it was not possible to generate higher test article concentrations by means of standard aerosol generation equipment. The exposure to the maximum attainable concentration was thus considered a limit test as stated in the OECD test guideline 403. From the absence of mortalities it can be assumed that the LC50 to both sexes is greater than 4200 mg/m³ air.

The animals of both sexes exposed to the test article experienced the symptoms piloerection and dyspnea to a similar extent. They recovered within 5 days. The body weight development was within normal limits. At autopsy, no deviations from normal morphology could be detected in all animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

4 200 mg/m³ air

Quality of whole database:

An inhalation study conducted with Fe(Na)EDDHA (CAS 84539-55-9) is considered a limit test since the maximum attainable concentration of 4200 mg/m³ was achieved. No further inhalation studies are available. Inhalation is not relevant route of exposure.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

from 2000-08- 09 to 2000-08-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species, strain: rat, Sprague-Dawley ICO: OFA-SD (IOPS Caw)
- Source: Iffa Credo, 69210 LArbresle, France.
- Age at study initiation: 8 weeks old
- Weight at study initiation: 249 ± 8 g for the males and 225 ± 8 g for the females
- Fasting period before study: no
- Housing: during the acclimatization period, one to seven animals of the same sex were housed in polycarbonate cages (48 cm x 27 cm x 20 cm).
During the treatment period, the animals were housed individually in polycarbonate cages (35.5 cm x 23.5 cm x 19.3 cm).
Each cage contained dust-free sawdust (SICSA, 94142 Alfortville, France).
- Diet (e.g. ad libitum): ad libitum, A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2000-08- 09 To: 2000-08-23

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

purified by reverse osmosis

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area (5 cm x 6 cm for the females and 5 cm x 7 cm for the males)
- % coverage: 10
- Type of wrap if used: restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: yes. A single dose of 2000 mg/kg of the test substance in its original form was placed on a hydrophilic gauze pad pre-moistened with 2 mL of water

VEHICLE
- Amount(s) applied (volume or weight with unit): 2 mL

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: the data on historical control rats were used

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
Type, time of onset and duration of clinical signs were recorded for each animal individually. The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15.

- Necropsy of survivors performed: yes. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin. No microscopic examination was performed.

- Other examinations performed: From day 2, any local cutaneous reaction was recorded

Statistics:

No

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no findings

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Other findings:

No cutaneous reactions were observed.
A slight brownish coloration of the skin which could have masked a possible discrete erythema, was noted in most of the animals on day 2 only.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the dermal LD50 of the test substance Fe3KEDDHSA is higher than 2000 mg/kg in rats.

Executive summary:

The acute dermal toxicity of the test substance Fe3KEDDHSA was evaluated in rats according to OECD TG 402. The test substance in its original form was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females) at the dose of 2000 mg/kg bw. Purified water was used in order to moisten the test substance and ensure good contact with the skin as well as to remove residual test substance after removal of the dressing. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance. All animals were subjected to necropsy.

No clinical signs and no deaths were observed during the study. A reduced weight gain was seen in 1/5 females between day 1 and day 8. The overall body weight gain of the other animals was similar to that of historical control animals at the test facility. No cutaneous reactions were observed. A slight brownish coloration of the skin which could have masked a possible discrete erythema, was noted in most of the animals on day 2 only. No apparent abnormalities were observed at necropsy in any animal. Under the experimental conditions of this study, the dermal LD50 of the test substance EDDHAS Fe 3K is detremined to be higher than 2000 mg/kg in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

There is no deficiencies in the available data set. The data on structurally related substances is reliable and consisitent.

Additional information

Oral route

The acute oral toxicity of the test substance Fe(3K)EDDHSA (EC No. 462 -490 -6) was evaluated in rats according to the "Acute Toxic Class Method" (Centre International de Toxicologie, 2000a, Report No. 20501 TAR). The study was conducted in compliance with the OECD TG 423. The test substance was prepared in purified water and was administered by oral route (gavage), with a volume of 10 mL/kg, to groups of fasted Sprague-Dawley rats. As the test substance was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by administering 2000 mg/kg of the test substance to one group of three males. As no deaths occurred, the study was completed by the administration of the dose-level of 2000 mg/kg to one group of three females. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test substance. All animals were subjected to necropsy.

Neither clinical signs nor mortalities were observed in the animals given 2000 mg/kg of the test substance. The overall body weight gain of the animals was not affected by this treatment. At necropsy, no apparent abnormalities were observed. Under the experimental conditions of this study, the oral LD50 of the test substance Fe(3K)EDDHSA is higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose-level.

In two acute oral toxicity studies according to OECD Guideline 401 and GLP, conducted with Fe(Na)EDDHA (CAS 84539 -55 -9) the LD50 in albino rats and Sprague-Dawley CD strain rats was determined to be greater than 2000 mg/kg bw. Body weight development was not impaired. No deaths and clinical signs were observed in both studies (Hempstock, 1996, Report No. 003/081; CIBA-GEIGY, 1993b, Report No. 931140) .

Inhalation route

An acute inhalation toxicity study, according to OECD Guideline 403 was performed in albino rats with Fe(Na)EDDHA (CAS 84539 -55 -9) (CIBA-GEIGY, 1993a, Report No. 931142). Upon a four-hour acute inhalation exposure and a 14-days post-treatment observation period, no mortalities were elicited by the test item at a maximum attainable concentration of 4202 ± 188 mg/m³. Due to the properties of the test material, it was not possible to generate higher test article concentrations by means of standard aerosol generation equipment. The exposure to the maximum attainable concentration was thus considered a limit test as stated in the OECD test guideline 403. From the absence of mortalities it can be assumed that the LC50 to both sexes is greater than 4200 mg/m³ air. The animals of both sexes exposed to the test article experienced the symptoms piloerection and dyspnoea to a similar extent. They recovered within 5 days. At autopsy, no deviations from normal morphology could be detected in all animals.

Dermal route

The acute dermal toxicity of the test substance Fe(3K)EDDHSA (EC No. 462 -490 -6) was evaluated in rats according to OECD Guideline 402 (Centre International de Toxicologie, 2000b, Report No. 20501 TAR). The test substance in its original form was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females) at the dose of 2000 mg/kg bw. Purified water was used in order to moisten the test substance and ensure good contact with the skin as well as to remove residual test substance after removal of the dressing. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance. All animals were subjected to necropsy.

No clinical signs and no deaths were observed during the study. A reduced weight gain was seen in 1/5 females between day 1 and day 8. The overall body weight gain of the other animals was similar to that of historical control animals at the test facility. No cutaneous reactions were observed. A slight brownish coloration of the skin which could have masked a possible discrete erythema, was noted in most of the animals on day 2 only. No apparent abnormalities were observed at necropsy in any animal. The dermal LD50 of the test substance Fe(3K)EDDHSA is determined to be higher than 2000 mg/kg in rats.

Two acute dermal toxicity studies (limit test), according to OECD Guideline 402 were performed with the test substance Fe(Na)EDDHA (CAS 84539 -55 -9) in Sprague-Dawley CD strain rats and in albino rats (Hempstock, 1996, Report No. 003/082; CIBA-GEIGY, 1993b, Report No. 931141). All animals survived the 2000 mg/kg bw dermal application. No mortalities occurred in both studies and body weight development was not impaired. No clinical signs of toxicity were observed. The acute dermal LD50 values were considered to be greater than 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Key study conducted with the nearest analogue Fe(3K)EDDHSA (EC 462-490-6)

Justification for selection of acute toxicity – inhalation endpoint
Key study conducted with the related substance Fe(Na)EDDHA (CAS 84539-55-9)

Justification for selection of acute toxicity – dermal endpoint
Key study conducted with the nearest analogue Fe(3K)EDDHSA (EC 462-490-6)

Justification for classification or non-classification

Based on the results of the acute toxicity studies, available for the nearest neighbours Fe(3K)EDDHSA (EC No. 462 -490 -6) and Fe(Na)EDDHA (CAS 84539 -55 -9), the target substance Fe(3Na)EDDHSA is not subject to classification and labelling for acute toxic effects according to Regulation (EC) 1272/2008.