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EC number: 201-133-9 | CAS number: 78-69-3
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 5 mice per sex and dose were treated simultaneously by intraperitoneal injection with preparations of the test substance in carboxymethylcellulose containing 2-3 drops of Cremophor EL. The concentrations of these preparations were usually adjusted to achieve comparable volumes (10 ml/kg bw).
Group-wise documentation of clinical signs was performed over the 7- to 14-day study period. - GLP compliance:
- no
- Limit test:
- no
Test material
- 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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: average weight: male 30 g; female: 26 g
- Diet: Altromin R 1324, Altromin GmbH, Lage ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- VEHICLE
- Concentration in vehicle: Pretest: 10 %, 46.4%, 100% Main Test: 3.16%, 4.64%, 6.81%, 10%
- Amount of vehicle: 10 ml/kg bw
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight
DOSAGE PREPARATION (if unusual): administered in 0,5 % in aquous
Carboxymethyl cellulose solution with 2 to 3 drops of Cremophor EL - Doses:
- 316, 464, 681, 1000 µl/kg bw:
- No. of animals per sex per dose:
- 5 males and 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; d1-d14 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. 0.55 mL/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 455 mg/kg bw
- Remarks on result:
- other: calculated with a density of 0.827 - 0.828 g/cm³
- Clinical signs:
- Dyspnoea, apathy, abdominal and lateral position, staggering, paresis of hindlimbs, partially atonia, partially sedate-like state with loss of cornea and pain reflex, partially rolling-and-stretching convulsions, partialy tonic and clonic spasms, exsiccosis, poor general condition, late cases of death, partially weight loss at the beginning of study
- Body weight:
- mean body weight:
dose 1000 µl/kg bw: male: day3: 26 g;
dose 1000 µl/kg bw: female: day3: 23 g; day 7: 25 g; day 10: 28 g;
dose 681 µl/kg bw: male: day3: 30 g, day 7: 34 g, day 10: 34 g;
dose 681 µl/kg bw: female: day3: 23 g; day 7: 27 g; day 10: 28 g;
dose 464 µl/kg bw: male: day3: 29 g, day 7: 31 g, day 10: 33 g;
dose 464 µl/kg bw: female: day3: 27 g; day 7: 29 g; day 10: 31 g;
dose 316 µl/kg bw: male: day3: 33 g, day 7: 34 g, day 10: 35 g;
dose 316 µl/kg bw: female: day3: 27 g; day 7: 28 g; day 10: 29 g; - Gross pathology:
- In two mice (dose 1000 µl/kg bw) intraabdominal precipitation of substance was detected.
Other findings were not reported.
Any other information on results incl. tables
Mortality:
Pretest:
100 %: 5/5 female + 5/5 male animals after 30 min
46.4 %: 2/2 male animals after 15 min
10%: 2/2 male animals after 1h/3d
Main test:
| dose (µl/kg bw) | concentration (%) | number of animals | mortality within | ||||
| 1 h | 24 h | 48 h | 7 d | 14 d | |||
| 1000 | 10 | 5 M | 0/5 | 2/5 | 4/5 | 5/5 | 5/5 |
| 5 F | 0/5 | 0/5 | 1/5 | 3/5 | 4/5 | ||
| 681 | 6.81 | 5 M | 0/5 | 2/5 | 2/5 | 4/5 | 4/5 |
| 5 F | 0/5 | 1/5 | 1/5 | 1/5 | 2/5 | ||
| 464 | 4.64 | 5 M | 0/5 | 0/5 | 1/5 | 3/5 | 3/5 |
| 5 F | 0/5 | 1/5 | 1/5 | 1/5 | 1/5 | ||
| 316 | 3.16 | 5 M | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| 5 F | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | ||
Applicant's summary and conclusion
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