Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Normal, healthy rats of the Charles River strain, equally divided as to sex and weighing 200 to 300 grams, were used in this study. The animals were fasted for eighteen hours prior to dosing. The test material was fed as received. A rigid stomach tube was employed for the dosing.
Following the administration of the test material the animals were observed for fourteen days for signs of toxicity. Throughout the observation period the animals were housed in raised wire mesh cages in an air conditioned room. They were fed their regular diet of Lab Blox and water ad libitum.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloctane-1,7-diol
EC Number:
203-517-1
EC Name:
3,7-dimethyloctane-1,7-diol
Cas Number:
107-74-4
Molecular formula:
C10H22O2
IUPAC Name:
3,7-dimethyloctane-1,7-diol
Test material form:
liquid
Specific details on test material used for the study:
Name: Hydroxycitronellol
Batch: E. O. A. # 72-128 / 5-25-72

Test animals

Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals or test system and environmental conditions:
Normal, healthy rats of the Charles River strain, equally divided as to sex and weighing 200 to 300 grams, were used in this study. The animals were fasted for eighteen hours prior to dosing. The test material was fed as received. A rigid stomach tube was employed for the dosing.
Following the administration of the test material the animals were observed for fourteen days for signs of toxicity. Throughout the observation period the animals were housed in raised wire mesh cages in an air conditioned room. They were fed their regular diet of Lab Blox and water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not further specified
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 m / 5 f
Control animals:
not specified
Details on study design:
The animals were fasted for eighteen hours prior to dosing. Following the administration of the test material the animals were observed for fourteen days for signs of toxicity.
Statistics:
not further specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
The dosing caused no mortality.
Clinical signs:
The dosing caused no adverse effects.
Body weight:
The dosing caused no adverse effects.
Gross pathology:
not further specified

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 was greater as 5 mL/kg bw.
Executive summary:

The single oral dosing of rats with 5 mL/kg of the test item caused no mortality or any visible toxic effects. As this dose level did not produce a toxic effect, a complete LD50 study was not performed.