Reaction mass of (2Z)-5-[(1R,3R,6S)-2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl]-2-methyl-2-penten-1-ol and (2Z)-2-methyl-5-[(1S,2R,4R)-2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl]-2-penten-1-ol

Acute Toxicity: oral

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

Test material information

Constituent 1

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.