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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1980
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

Constituent 1
Chemical structure
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:
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