3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Test substance represents a main component (stereoisomer) of the registered substance.Test substance represents a main component (stereoisomer) of the registered substance.

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (non-GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol

EC Number:

255-053-4

EC Name:

(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol

Cas Number:

40716-66-3

Molecular formula:

C15H26O

IUPAC Name:

(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol

Details on test material:

- Name of test material (as cited in study report): trans-Nerolidol
- Analytical purity: 99 %

Specific details on test material used for the study:

Test substance represents a main component (stereoisomer) of the registered substance.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: D. Thomae
- Weight at study initiation: males 180g/188 g; females 188/190 g in two dose groups respectively
- Fasting period before study: about 16 h before administration of the test material
- Housing: 5 animals per cage: stainless steel wire mesh cages, type III (Becker & Co., Castrop-Rauxel, Germany)
- Diet: Kliba Labordiaet 343 (Klingenthalmuehle AG; Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Air changes: fully air-conditioned room
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

- Concentration in vehicle: 2610 mg/kg bw: 52.2 % (w/v); 2000 mg/kg bw: 40.0 % (w/v)
- Amount of vehicle: 5 ml/kg bw for both doses
- Justification for choice of vehicle: test substance is unsoluble in water

Doses:

2000, 2610 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

TIME OF DAY OF ADMINISTRATION: in the morning
OBSERVATION PERIOD: 14 days
SIGNS AND SYMPTOMS: recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
PATHOLOGY: withdrawal of food 16 h before sacrifice with CO2, then necropsy with gross-pathological examination. Necropsy of all animals that died.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 610 mg/kg bw

Mortality:

In both dose groups 0/10 animals died.

Clinical signs:

Clinical signs of toxicity were seen in male and female rats. For details see "Remarks on results ..."

Body weight:

The body weight gain was within the normal range. For details see "Remarks on results ..."

Gross pathology:

No substance related findings noted.

Any other information on results incl. tables

CLINICAL SIGNS:
DOSE (MG/KG)                    / 2610     / 2000
-----------------------------------------------------------
MALES:
DYSPNEA                         / 4H-1D    / 4H-2D
APATHY                          / 4H-1D    / 4H-2D
ABNORMAL POSITION               / 4H-5H    / -
STAGGERING                      / 4H-1D    / 4H-2D
ATONIA                          / 4H-5H    / -
PARESIS                         / 4H-5H    / -
PILOERECTION                    / 4H-1D    / -
EXSICCOSIS                      / 4H-5H    / -
POOR GENERAL STATE              / 4H-1D    / 4H-2D

FEMALES:
DYSPNEA                         / 4H-1D    / 4H-2D
APATHY                          / 4H-1D    / 4H-2D
ABNORMAL POSITION               / 4H-5H    / 4H
STAGGERING                      / 4H-1D    / 4H-2D
ATONIA                          / 4H-5H    / 4H
PARESIS                         / 4H-5H    / 4H
PILOERECTION                    / 4H-1D    / 4H
EXSICCOSIS                      / 4H-5H    / 4H
POOR GENERAL STATE              / 4H-1D    / 4H-2D
-----------------------------------------------------------
H = hour; D = day

MEAN BODY WEIGHT (g)
DOSE (MG/KG)                    / 2610     / 2000
-----------------------------------------------------------
MALES:
BEGINNING OF THE TEST           / 188      / 180
AFTER 7D                        / 253      / 255
AFTER 13D                       / 288      / 299

FEMALES:
BEGINNING OF THE TEST           / 190      / 188
AFTER 7D                        / 222      / 222
AFTER 13D                       / 228      / 232
-----------------------------------------------------------