ferrocene, [4-(dimethylsilyl)butyl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 June - 20 August 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(cyclopenta-2,4-dien-1-yl)({2-[4-(dimethylsilyl)butyl]cyclopenta-2,4-dien-1-yl})iron

EC Number:

600-343-1

Cas Number:

102744-79-6

Molecular formula:

C16H24SiFe

IUPAC Name:

(cyclopenta-2,4-dien-1-yl)({2-[4-(dimethylsilyl)butyl]cyclopenta-2,4-dien-1-yl})iron

Test material form:

liquid

Details on test material:

Appearence: brown-red liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SNPE / LD 2363
- Appearence: brown-red liquid
- Name of test item: CL 905

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerated under nitrogen
- Solubility and stability of the test substance in the solvent/vehicle: soluble in common solvents (acetone, hexane, chlorinated solvents)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD (SD) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Saint Aubin les Elbeuf, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 142 ± 5 g for males; 126 ± 6 g for females
- Fasting period before study: 18 h before administration
- Housing: 5 of the same sexe/cage; polycarbonate cage
- Diet (e.g. ad libitum): ad libitum (rats - souris entretien; A 04 C)
- Water (e.g. ad libitum): ad libitum (0.22 µm filtered water)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20 %
- Air : filtered with absolute-type filters
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

300

Details on oral exposure:

VEHICLE
- Concentration in vehicle: required amount for the dose
- Amount of vehicle (if gavage): administration volume of 10 mL/kg bw
- Lot/batch no. (if required): 82202
- Provider: Prolabo, Paris, France
- Appearence: colorless liquid

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

1000, 1400, 1800, 2500 and 5000 mg/kg bw

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: clinical signs are followed frequently during the first hours following the administration and then daily. Mortality is recorded twice daily. Bodyweight is measured just before administration, and on Days 5, 8 and 15.
- Necropsy of survivors and dead animals is performed

Statistics:

LD50 was calculated by the Finney method. The 95% confidence interval was calculated according to the Fieller method.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 506 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 314 - <= 1 703

Mortality:

Percentage of mortality was 0, 40, 80, 100 and 90% at 1000, 1400, 1800, 2500 and 5000 mg/kg bw. See attached document

Clinical signs:

other: The major dose-related clinical signs were: sedation, hypokinesia and piloerection. These signs were observed from 15 min after administration for 3 to 10 days, depending on the dose (see attached document).

Gross pathology:

No anomalies recorded in animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the test conditions, the LD50 in males and females rats of the test item was calculated to be 1506 mg/kg bw. This leads to classification of the substance as category 4 (H302) for acute oral toxicity according to CLP Regulation (EC) N° (1272-2008) and GHS criteria.

Executive summary:

In a GLP study conducted according to OECD guideline 401, groups of 5 male and 5 female Sprague-Dawley rats were given a single dose of the test item suspended in PEG300 at the doses of 1000, 1400, 1800, 2500 and 5000 mg/kg bw. All animals were observed for mortality, clinical signs and bodyweights for 14 days and survivors were sacrificed for macroscopic examination.

Percentage of mortality was 0, 40, 80, 100 and 90% at 1000, 1400, 1800, 2500 and 5000 mg/kg bw. The major dose-related clinical signs were: sedation, hypokinesia and piloerection. These signs were observed from 15 min after administration for 3 to 10 days, depending on the dose. Slight decrease in bodyweight was observed from 1400 mg/kg bw in males and from 1800 mg/kg bw in females.

Under the test conditions, the LD50 in males and females rats of the test item was calculated to be 1506 mg/kg bw. This leads to classification of the substance as category 4 (H302) for acute oral toxicity according to CLP Regulation (EC) N° (1272-2008) and GHS criteria.