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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Immediate stimulation followed by ataxia.
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.