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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No details on study protocol
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

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
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
2000, 2500, 3200, 4000 and 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 and weighing: no data
- Necropsy of survivors performed: no data
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 3 800 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 060 - <= 4 710
Mortality:
1/10 at 2000 mg/kg bw; 2/10 at 2500 mg/kg bw; 5/10 at 3200 mg/kg bw; 5/10 at 4000 mg/kg bw; 7/10 at 5000 mg/kg bw.
Clinical signs:
Immediate stimulation followed by ataxia.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, the oral LD50 is ca. 3800 mg/kg bw in rats [3060-4710 mg/kg bw] therefore alpah-santalol is classified in Category 5 according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, groups of rats (10/dose) were administered a single oral dose of alpha-santalol at 2000, 2500, 3200, 4000 or 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.


 


Mortality was observed at all dose levels: 1/10 at 2000 mg/kg bw; 2/10 at 2500 mg/kg bw; 5/10 at 3200 mg/kg bw; 5/10 at 4000 mg/kg bw; 7/10 at 5000 mg/kg bw. Clinical signs included immediate stimulation followed by ataxia.


Rat Oral LD50 = 3800 mg/kg bw [3060 -4710 mg/kg bw]


 


Under the test conditions, alpha santalol is classified in Category 5 according to the Regulation EC No. 1272/2008 (CLP) and to the GHS. 


Although poorly detailed, this study is considered to be acceptable to fulfill the acute oral toxicity endpoint.