Ferula galbaniflua, ext.

Endpoint summary

Description of key information

Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel.2)

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:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard acute method

GLP compliance:

no

Remarks:

pre-GLP

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
- Weight at study initiation: 150-300 g
- Fasting period before study: Overnight
- Housing: Animals were individually housed.
- Diet: Commercial diets, ad libitum
- Water, ad libitum

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION:
Test substance was prepared as 50% (w/v or v/v) solutions or suspensions in corn oil.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days.
- Necropsy of survivors performed: Yes; gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.

Statistics:

LD50 was calculated according to Horn's method (Horn, 1956).

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain.

Gross pathology:

At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.

Executive summary:

In an acute oral toxicity study, group of 10 Sprague-Dawley rats were given a single oral dose of Galbanum at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

 

No mortality was observed. Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain. At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Some details of the experimental conditions are missing (test substance, animal conditions, bodyweights) but the main useful data are described.

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

Acute toxicity: via oral route

In an acute oral toxicity study, group of 10 Sprague-Dawley rats were given a single oral dose of Galbanum at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

No mortality was observed. Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain. At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.

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:

- not classified according to the Regulation (EC) No. 1272/2008 and GHS.

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 composition (> 10% of aspiration toxicants or hydrocarbons), the registered substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.