Reaction mass of Trisodium tris(D-gluconato(2-)-κO1,κO2)ferrate(3-) and Sodium chloride

Endpoint summary

Description of key information

Acute toxicity studies are available for Fe-EDTA and Na-glucoheptonate

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

July 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed study under GLP

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
see section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CD/Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chalrles River, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 177-183 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55 +/-5%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 To:26th July 2007

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage):10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

no

Statistics:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortalities.

Mortality:

no mortalities

Clinical signs:

other: no clinical signs

Gross pathology:

No pathologicla changes observed

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

LD50 exceeding the limit dose of 2000 mg/kg bw

Executive summary:

In an acute oral toxicity study according to OECD guideline 423 a group of female CD rats received a limit dose of 2000 mg/kd bw of FeNaEDTA by gavage administration. No adverse effects were noted, no clinical signs, no mortalities, no effect on body weight and no adverse findings at final necropsy after a 14 days observation period. The LD50 (oral,rat) exceeded 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Well performed GLP studies available

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP; one remark: 44% of the particles was smaller than 4 micron, indicating that the MMAD was slightly above 4 micron (1-4 micron is required)

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 51 days(males), 65 days (females)
- Weight at study initiation: 214 - 250 g
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55 +/-15%
- Photoperiod (hrs dark / hrs light): 12/12 hours

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: water

Details on inhalation exposure:

As no dust aerosol could be generated, the test item was dissolved in water to a 5.7% solution the approximate limit of solubility.This solution was used to generate the aerosol of nominal 55.56 mg/L air.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

nominal concentration: 55.56 mg/L air
actual concentraion 2.75 +/- 0.19 mg/L air

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not required

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.75 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: +/- 0.19, No mortalities.

Mortality:

none

Clinical signs:

other: none

Body weight:

All animals gained the expected body weight.

Gross pathology:

No pathological findings

nominal concentration	actual concentration	mass median aerodynamic diameter	respirable amount particle size ≤4 µm	respirable amount particle size ≤4 µm
[µL/L air]	[mg/L air]	[µm]	[mg/L air]	[%]
55.56	2.75	2.730	1.21	44.1

Interpretation of results:

other: No classification needed

Remarks:

Migrated information

Conclusions:

LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L the maximum attainable concentration

Executive summary:

In an acute inhalation toxicity study according to OECD guideline 403 a group of 5 rats per sex was exposed to an aerosol concentration of 2.75 +/-0.19 mg/L air for 4h by the inhalation route. No adverse effects were noted, no clinical signs, no effects on body weight and no adverse findings at final necropsy after a 14 days observation period. It was noted that the MMAD was slight above 4 micron whereas 1 -4 micron is required.

The LC₅₀(rat, dermal) exceeded 2.75 +/- 0.19 mg/L air.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Well performed GLP study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

July 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Germanz
- Age at study initiation: 51 days(males), 65 days(femalse)
- Weight at study initiation: 207 - 253 g
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 °C
- Humidity (%): 55+/-5% r.H.
- Photoperiod (hrs dark / hrs light): 12/12 hours


IN-LIFE DATES: From: 11 To:25 July 2007

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5x6 cm²
- Type of wrap if used: gauze, plastic sheet secured with adhesive


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure:24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):10 mL/kg bw
- Concentration (if solution): 0.2 mg/mL

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Statistics:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortalities.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no adverse findings

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

LD50 (dermal, rat) exceeds 2000 mg/kg bw

Executive summary:

In an acute dermal toxicity study according to OECD guideline 402 a group of 5 rats per sex were administered a limit dose of 2000 mg/kg bw by the dermal route for 24h. No adverse effects were noted, no clinical signs, no effects on body weight, no local signs and no adverse findings at final necropsy after a 14 days observation period.

The LD50 (rat, dermal) exceeded 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Well performed GLP studies available

Justification for classification or non-classification

As no acute toxicity was observed for the read across substances Fe-EDTA and Na-glucoheptonate, no GHS classification needed for acute toxicity.