Concrete of Salvia sclarea L. (Lamiaceae) obtained from leaves, flowers and twigs by apolar hydrocarbon solvent extraction with or without purification by molecular distillation

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

15 March - 19 April 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no data about purity and no certificate of analysis of the test substance; no data on bodyweight changes

Justification for type of information:

Sclareol is one of the main constituent of Clary sage concrete (it represents between 40 and 80% of the substance).

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Sclareol is one of the main constituent of Clary sage concrete (it represents between 40 and 80% of the substance).

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Executive summary:

In an acute oral toxicity study performed similarly to OECD Guideline 401, a single oral (gavage) dose of 5000 mg/kg bw of the test substance, in 25% gravimetric suspension in corn oil, was given to 5 male

and 5 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days; and all were macroscopically necropsied after sacrifice.

No deaths occurred. Clinical signs including slight depression, and moist and matter hair were noted in all animals within 3 -24 hours after treatment, but all appeared normal after 5 days. Internal organs

on superficial examination appeared normal except for a deposit of fibrous tissue in the thoracic cavity in one animal.

Rat Oral LD50 > 5000 mg/kg bw.

Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw.

Therefore Clary sage concrete is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data about purity and no certificate of analysis of the test substance; no data on bodyweight changes

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[1R-[1α(R*),2β,4aβ,8aα]]-2-hydroxy-α,2,5,5,8a-pentamethyl-α-vinyldecahydronaphthalene-1-propan-1-ol

EC Number:

208-194-0

EC Name:

[1R-[1α(R*),2β,4aβ,8aα]]-2-hydroxy-α,2,5,5,8a-pentamethyl-α-vinyldecahydronaphthalene-1-propan-1-ol

Cas Number:

515-03-7

Molecular formula:

C20H36O2

IUPAC Name:

(1R,2R,4aS,8aS)-1-[(3R)-3-hydroxy-3-methylpent-4-enyl]-2,5,5,8a-tetramethyl-3,4,4a,6,7,8-hexahydro-1H-naphthalen-2-ol

Test material form:

other: the substance is considered as liquid

Details on test material:

- Name of test material (as cited in study report): sclareol
- Substance type: monoconstituent
- Physical state: liquid
- Analytical purity: see confidential details
- Impurities (identity and concentrations): see confidential details
- Composition of test material, percentage of components: see confidential details
- Isomers composition: see confidential details
- Purity test date: see confidential details
- Lot/batch No.: see confidential details
- Expiration date of the lot/batch: see confidential details
- Stability under test conditions: not applicable
- Storage condition of test material: not applicable

Specific details on test material used for the study:

Batch: W1626

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Licensed dealer
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200-250 g
- Fasting period before study: ca. 18 hours
- Housing: Housed in galvanized cages with indirect bedding, in a temperature controlled room
- Diet: Growth and maintenance ration from a commercial producer, ad libitum
- Water: Ad libitum
- Acclimation period: At least 2 days

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hours dark / 12 hours light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

DOSAGE PREPARATION: Test item was used in 25% gravimetric suspension in corn oil.

Doses:

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: Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage, and at least once daily thereafter for a total of 14 days.
- Necropsy: Non-survivors and animals surviving the 14 day observation period were subjected to gross necropsy, with all findings noted.

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

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:

Clinical signs including slight depression, and moist and matter hair were noted in all animals within 3 -24 hours after treatment, but all appeared normal after 5 days.

Body weight:

No data

Gross pathology:

Internal organs on superficial examination appeared normal except for a deposit of fibrous tissue in the thoracic cavity in one animal.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Executive summary:

In an acute oral toxicity study performed similarly to OECD Guideline 401, a single oral (gavage) dose of 5000 mg/kg bw of the test substance, in 25% gravimetric suspension in corn oil, was given to 5 male and 5 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days; and all were macroscopically necropsied after sacrifice.

No deaths occurred. Clinical signs including slight depression, and moist and matter hair were noted in all animals within 3 -24 hours after treatment, but all appeared normal after 5 days. Internal organs on superficial examination appeared normal except for a deposit of fibrous tissue in the thoracic cavity in one animal.

 

Rat Oral LD50 > 5000 mg/kg bw.

 

Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.