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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

Sodium feredetate

EC Number:

239-802-2

EC Name:

Sodium feredetate

Cas Number:

15708-41-5

Molecular formula:

C10H12N2O8FeNa

IUPAC Name:

Sodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; iron(+3) cation

Constituent 2

Reference substance name:

FeNaEDTA

IUPAC Name:

FeNaEDTA

Details on test material:

Product brand: Sigma
Lot: 016K0107
Iron by ICP-AES: 14.4%
Sodium by ICP-AES: 6.1%
EDTA content: 69.9%

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.