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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Comparable to guideline study with acceptable restrictions.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
reduced post observation time  (7 days instead of 14)
Principles of method if other than guideline:
In principle, the methods described in the OECD Guideline 401 were used. Several groups of 10 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methylbut-2-en-1-ol
EC Number:
209-141-4
EC Name:
3-methylbut-2-en-1-ol
Cas Number:
556-82-1
Molecular formula:
C5H10O
IUPAC Name:
3-methylbut-2-en-1-ol
Details on test material:
Name of test substance: 3-Methylbut-2-en-1-ol (Prenol)
Purity: 95 %
Impurities: no further data on impurities given

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: 160-260 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water; emulsion in water containing traganth
Details on oral exposure:
- Concentration in vehicle: The doses were administered at concentrations of 2% (0.2 ml/kg bw), 20% (1.6, 2.0 and 2.5 ml/kg bw), and 30% (3.2 and 6.4 ml/kg bw) aqueous emulsions, respectively.

Doses:
172, 1376, 1720, 2150, 2752 and 5504 mg/kg bw;
the original values were reported as 0.2, 1.6, 2.0, 2.5, 3.2 and 6.4 ml/kg bw. The mg/kg bw doses were based on a density of 0.86 g/ml at 20 °C.
No. of animals per sex per dose:
10 animals per sex per dose.
Control animals:
no
Details on study design:
Animals were inspected for signs of pharmacologic or toxicologic effects during a 7 days post observation period.
Body weight was measured before dosing. 
At the end of the observation period, survivors were sacrificed and necropsied as were animals that died.
The LD50 value was estimated (calculation method not mentioned in the raw data).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 591 mg/kg bw
Remarks on result:
other: LD50 value was reported to be ca. 1.85 ml/kg bw
Mortality:
No deaths occurred at the lower doses up to 1.6 ml/kg bw. All animals died at 2.0 ml/kg bw and above.

Time of death and number of deaths at each dose:
- 6.4 ml/kg bw: 10/10 males and 10/10 females died within 24 hrs
- 3.2 ml/kg bw: 10/10 males and 10/10 females died within 24 hrs
- 2.5 ml/kg bw: 9/10 males and 10/10 females died within 24 hrs
- 2.0 ml/kg bw: 7/10 males and 10/10 females died within 24 hrs
- 1.6 ml/kg bw: 0/10 males and 0/10 females died within 7 days
- 0.2 ml/kg bw: 0/10 males and 0/10 females died within 7 days

From these data a LD50 value was estimated to be 1591  mg/kg bw after 7 days. The original LD50 value was reported to be ca. 1.85 ml/kg bw.
Clinical signs:
other: At 6.4 to 2.0 ml/kg bw:  Immediately after application, staggering, abdominal and lateral position, partly dorsal position, apathy, laboured and irregular breathing, secretion out of eyes and mouth, reddened eyes and ears. In the post observation days, ca
Gross pathology:
In 2 animals that died after application of 2.5 ml/kg bw, stomach dilated and filled with liquid, all other animals without findings in the inner organs.

Applicant's summary and conclusion