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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
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 10 mL/kg bw
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:
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
Body weight:
mean body weights:
male: day3: 199 g; day 7: 234 g; day 10: 210 g
female: day3: 163 g; day 7: 195 g; day 10: 209 g
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


 

Applicant's summary and conclusion