3,7-dimethyloctan-3-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

TEST PROCEDURE

Groups of 5 rats per sex and dose were treated simultaneously by gavage. Only one dose, i.e. 10 ml per kg body weight was applied.

Group-wise documentation of clinical signs was performed over the 14-day study period.
Body weight was recorded before and during the study.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloctan-3-ol

EC Number:

201-133-9

EC Name:

3,7-dimethyloctan-3-ol

Cas Number:

78-69-3

Molecular formula:

C10H22O

IUPAC Name:

3,7-dimethyloctan-3-ol

Details on test material:

- Name of test material (as cited in study report): Tetrahydrolinalool (THL); Substance-ID: XXVI 402
- Physical state: fluid
- Analytical purity: > 98%
- Molecular weight (if other than submission substance): 158 g/mol
- Other: pH 7
- Solubility: water: no; alcohol: yes

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean body weight: male 190 g, female 170 g
- Diet: Altromin R 1324 (Altromin GmbH, Lage) ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.9 ml (males), 1.7 ml (females)

Doses:

10 ml/kg bw (equal to 8270 mg/kg bw; calculated with a density of 0.827 -0.828 g/cm³)

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations of clinical symptoms: < 15 min, 15 min, 30 min, 1 h, 2 h, 4 h, 5 h; 1 d -14d (once per day on working days)
- Necropsy of survivors performed: yes
- Frequency of weighing: day 3, 7, 10

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 10 mL/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

8 270 mg/kg bw

Remarks on result:

other: calculated with density = 0.827 - 0.828 g/cm³

Mortality:

10 ml/kg bw: 1/5 male died within 48 h; 3/5 female died within 24 h

Clinical signs:

other: Dyspnea, apathy, lateral position, staggering, atonia, sedative-like state with loss of corneal and pain reflex, ataxia, spastic movements diarrhea, salivation and lacrimation, poor general condition (2h-3d), reduced weight gain at beginning of study

Gross pathology:

deceased animals: heart: acute dilatation; acute venous stasis
kidney: slightly brightened
sacrificed animals: organs: Nothing abnormal detected

Any other information on results incl. tables

Overall Mortality:

dose (µl/kg bw)	number of animals	Mortality within
		1 h	24 h	48 h	7 d	14 d
10000	5M	0/5	0/5	1/5	1/5	1/5
	5F	0/5	3/5	3/5	3/5	3/5