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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted similarly to OECD Guideline 401 with deviations: no data about purity and no certificate of analysis of test substance; no. of animals at two dose levels < 5; no details on environmental conditions, observation period: 7 days
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

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 test substance; no. of animals at two dose levels < 5; no details on environmental conditions, observation period: 7 days
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
before GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol
EC Number:
939-525-3
Cas Number:
1471313-03-7
Molecular formula:
C14H26O
IUPAC Name:
3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pentan-2-ol; 6-(2,2,3-trimethylcyclopent-3-en-1-yl)hexan-3-ol
Details on test material:
- Name of test material (as cited in study report): Sandalore
- Source: Proprietary Perfumes Ltd.
- Date received: 21 December 1976
- Physical state: Clear colourless liquid
- Specific gravity: 0.89
- pH: 4.0

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Housing: Animals were housed in individual cages.
- Fasting period before study: 4 h
- Diet: Commercial pelleted diet, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME ADMINISTERED: 10 mL/kg bw
Doses:
2, 5 and 10 mL/kg bw
No. of animals per sex per dose:
5 mL/kg bw: 3/sex/dose
2 and 10 mL/kg bw: 1/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Survivors were weighed before killing for post-mortem examination.
- Necropsy of survivors performed: Yes, survivors were killed at the end of the one week observation period.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to 8900 mg/kg bw; specific gravity: 0.89
Mortality:
- No mortality was observed.
Clinical signs:
other: - Mice dosed at 10 mL/kg bw were showing signs of stress within 30 minutes after treatment but recovered within one hour. - Mice dosed at 2 and 5 mL/kg bw appeared unaffected by the treatment.
Gross pathology:
- No macroscopic abnormalities were observed at study termination except pale intestines in the mice dosed at 10 mL/kg bw.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of the substance is higher than 2000 mg/kg bw in mice. Therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.
Executive summary:

In an acute oral toxicity study performed similarly to OECD Guideline 401, groups of mice (1 or 3/sex/dose) were given a single oral dose of the substance at 2, 5 and 10 mL/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 7 days and were all macroscopically necropsied after sacrifice.

No mortality and no abnormal clinical signs were observed. Animals dosed at 10 mL/kg bw were showing signs of stress within 30 minutes after treatment but recovered within one hour. The overall body weight gain of the treated animals was not affected by treatment with the test item except one female dosed at 5 mL/kg bw that lost a gram. No macroscopic abnormalities were observed at study termination except pale intestines in the mice dosed at 10 mL/kg bw. In this study, the combined oral LD50 was considered to be higher than 10 mL/kg bw (equivalent to 8900 mg/kg bw) in mice.

Under the test conditions, the oral LD50 is higher than 2000 mg/kg bw in mice. Therefore the substance is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.