ferrocene, [4-(dimethylsilyl)butyl]-

Endpoint summary

Description of key information

Acute toxicity, oral in rats: LD50 = 1506 mg/kg bw (OECD 401, GLP, K, Rel. 1)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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)

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 211 mg/kg bw

Quality of whole database:

Guideline GLP study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

- classified as category 4 (H302) for acute oral toxicity according to CLP Regulation (EC) N° (1272-2008) and GHS criteria.

Acute toxicity via Dermal route:This information is not available

Acute toxicity via Inhalation:This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal):This information is not available

Specific target organ toxicity: single exposure (Inhalation):This information is not available.

Based on its physical state, the registered substance is not classified for aspiration hazard according to CLP Regulation and GHS.