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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
no
Remarks:
Test not conducted for regulatory purposes, published research paper.
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
EC Number:
204-102-8
EC Name:
5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
Cas Number:
115-71-9
Molecular formula:
C15H24O
IUPAC Name:
5-(2,3-dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol
Constituent 2
Chemical structure
Reference substance name:
[1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
EC Number:
201-027-2
EC Name:
[1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
Cas Number:
77-42-9
Molecular formula:
C15H24O
IUPAC Name:
2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol
Constituent 3
Chemical structure
Reference substance name:
(Z)-5-[(6R)-4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl]-2-methylpent-2-en-1-ol
Cas Number:
176777-61-0
Molecular formula:
C15H24O
IUPAC Name:
(Z)-5-[(6R)-4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl]-2-methylpent-2-en-1-ol
Constituent 4
Chemical structure
Reference substance name:
(E)-(R)-(+)-5-(2,3-dimethyltricyclo[2.2.1.0^2,6]hept-3-yl)-2-methyl-2-penten-1-ol
Cas Number:
14490-17-6
Molecular formula:
C15H24O
IUPAC Name:
(E)-(R)-(+)-5-(2,3-dimethyltricyclo[2.2.1.0^2,6]hept-3-yl)-2-methyl-2-penten-1-ol
Constituent 5
Chemical structure
Reference substance name:
2-​Hepten-​1-​ol, 2-​methyl-​6-​(4-​methylphenyl)​-​, (2Z)​-
Cas Number:
122442-36-8
Molecular formula:
C15H22O
IUPAC Name:
2-​Hepten-​1-​ol, 2-​methyl-​6-​(4-​methylphenyl)​-​, (2Z)​-
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Albino Wistar rats of either sex weighing 150 - 200 g were housed under standard conditions at 25 ±5 ºC in a well-ventilated animal house approved by Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA Nº IAEC/37/10) under 12:12 h light - dark cycle. The experimental protocol (IAEC/NCP/37/10) was approved by Institutional Animal Ethical Committee, Nargund College of Pharmacy, Bangalore

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
3 rats, sex not specified
Control animals:
no
Details on study design:
The S. album stem hydro-alcoholic Extract (SASE) at a limit dose of 5000 mg/kg was administered orally to three rats and observed for behavioural changes, any toxicity and mortality up to 48 h. The extract was prepared by dissolving the commercial extract in distilled water and the concentration was not to exceed the dose of 1 mL/100 g by weight.
Statistics:
not required

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no mortalities in the limit test.
Clinical signs:
other: There were no signs of toxicity in the limit test.
Gross pathology:
no information about effects in the publication.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortalities or signs of toxicity have been observed in the limit test at a limit concentration of 5000 mg/kg body weight in rats.

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