Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1968-09-20 to 1968-09-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predating guidelines and GLP, but meeting the principles of OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-2-ol
EC Number:
200-908-9
EC Name:
2-methylbutan-2-ol
Cas Number:
75-85-4
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-2-ol
Details on test material:
- Name of test material: tertiary amyl alcohol

Test animals

Species:
rat
Strain:
other: "US-rats"
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 142 - 240 g (males); 120 - 174 g (females)

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1968-09-20 To: 1968-10-07

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous tragacanth emulsion
Details on oral exposure:
VEHICLE
- Vehicle concentration: 30% (6400, 3200 mm³/kg bw) , 20% (1600 mm³/kg bw), 2% (200 mm³/kg bw)
Doses:
6400, 3200, 1600 or 200 mm³/kg bw
No. of animals per sex per dose:
10 males and 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight taken at study start only for dose determination, but not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs monitored but frequency unknown, gross necropsy on fatalities
Statistics:
not performed

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 400 other: mm³/kg bw
Based on:
test mat.
Remarks on result:
other: 5184 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 400 other: mm³/kg bw
Based on:
test mat.
Remarks on result:
other: > 5184 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 5 000 other: mm³/kg bw
Based on:
test mat.
Remarks on result:
other: 4050 mg/kg bw
Mortality:
Totals after 14-days:
6400 mm³/kg bw: 10/20
3200 mm³/kg bw: 1/20
1600 mm³/kg bw: 0/20
200 mm³/kg bw: 0/20

Males:
6400 mm³/kg bw: 2/10 (1/10 within 1 h, 2/10 within 24 h)
3200 mm³/kg bw: 1/10 (0/10 within 1 h, 1/10 within 24 h)
1600 mm³/kg bw: 0/10
200 mm³/kg bw: 0/10

Females:
6400 mm³/kg bw: 8/10 (7/10 within 1 h, 8/10 within 24 h)
3200 mm³/kg bw: 0/10
1600 mm³/kg bw: 0/10
200 mm³/kg bw: 0/10
Clinical signs:
other: 3200 and 6400 mm³/kg bw Immediately after application: prone or lateral position, irregular respiration, narcosis; 1 day: panting, ruffled fur; 2 days: fully recovered 1600 mm³/kg bw Immediately after application: dyspnoea, watery secretion from snout, wa
Gross pathology:
Organs: no abnormalities detected
Perished animals: sepsis
Other findings:
none

Applicant's summary and conclusion