Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 May 2000 - 18 May 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed according to GLP principles and followoing the guidelines of OECD 423.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement of Compliance
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dihydrolinalool
- Physical state: clear colourless liquid
- Stability under storage conditions: stable
- Storage condition of test material: refrigerated; protected from light.
- Other: Specific gravity: -0,85 g/cm3

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 7 weeks old
- Weight at study initiation: Not exceeding +/- 20% of the sex mean.
- Fasting period before study: 20 hrs (max) before dosing until approx 3 (females) or 4,25 hrs (males) after administration of the test substance.
- Housing: 3 animals per sex per cage in labelled polycarbonate cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days before the start of the treatment under laboratory conditions.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: no vehicle


MAXIMUM DOSE VOLUME APPLIED:
2,35 ml/kg bw


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Group 1: 3 females; 2000 mg/kg
Group 2: 3 males; 2000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: Mortality/viability: Twice daily; Body weights: Day 1, 8 and 15; clinical signs: at periodic intervals on the
day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Statistics:
No statistical analysis performed (the method is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Preliminary study:
Not relevant.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occurred.
Clinical signs:
Lethargy, hunched posture, chromodacryorrhoea (nose) and/or ptosis were noted among the females dosed at 2000 mg/kg. No clinical signs were
noted among males dosed at 2000 mg/kg. The animals had recovered from the symptoms between day 2 and 4.
Body weight:
The body weight gain shown by the animals was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
No data.

Any other information on results incl. tables

FEMALES GROUP 1 (2000 MG/KG)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Test day

 

1

1

1

2

3

4

5

6

7

8

51

10

11

12

13

14

15

Time after treatment. Hours:

 

0

2

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANIMAL NUMBER

 SIGNS

MAX.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GRADE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

BEHAVIOR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LETHARGY ...

(3)

 

1

1

 

 

 

 

 

 

 

 

 

 

 

 

 

+

 

POSTURE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HUNCHED POSTURE...

(1)

 

1

1

 

 

 

 

 

 

 

 

 

 

 

 

 

+

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

BEHAVIOR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LETHARGY ...

(3)

 

2

1

1

 

 

 

 

 

 

 

 

 

 

 

 

+

 

POSTURE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HUNCHED POSTURE...

(1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

+

 

SECRETION I EXCRETION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CHROMODACRYORRHOEA (NOSE)..

(3)

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

+

 

VARIOUS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PTOSIS ...

(3)

 

1

1

 

 

 

 

 

 

 

 

 

 

 

 

 

+

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

BEHAVIOR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LETHARGY ...

(3)

 

1

1

 

 

 

 

 

 

 

 

 

 

 

 

 

+

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of Dihydrolinalool in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on the results and according to EC criteria for the classification and labelling requirements for dangerous substances and preparations
Dihydrolinalool does not have to be classified and has no obligatory labelling requirement for oral toxicity.
Executive summary:

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part 8.1 tris "Acute Toxicity-Oral, Acute Toxic Class Method" and OECD No.423, "Acute Oral Toxicity - Acute Toxic Class Method".

DIHYDROLINALOOL was administered by oral gavage to three Wistar rags of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred.

Lethargy, hunched posture, chromodacryorrhoea (nose) and/or ptosis were noted among the females dosed at 2000 mg/kg. No clinical signs were noted among males dosed at 2000 mg/kg. The animals had recovered from the symptoms between days 2 and 4.

The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of DIHYDROLINALOOL in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), DIHYDROLINALOOL does not have to be classified and has no obligatory labelling requirement for oral toxicity.