Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1698-10-29 and 1968-11-058
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

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:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF Test (internal standard procedure). In principle, the methods described by OECD TG 401 were used.
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-methyl-3-buten-1-ol
- Analytical purity: 99%
No further data.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
male and female Sprague-Dawley rats
- Source: Gassner
- Weight at study initiation: body weight range: males: 138 - 190 g; females: 124 - 158 g
No further data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous Traganth (emulsion)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 - 30 % (v/v)
Doses:
ca. 170, 1360, 2720, 5440 mg/kg bw (200, 1600, 3200, 6400 ml/kg bw)
No. of animals per sex per dose:
10 males and 10 females per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Group-wise documentation of clinical signs was performed over the 7-day observation period. Body weight was determined before the study only, as it was needed for determination of the dose.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 440 mg/kg bw
Mortality:
Four out of 20 rats of group 1 (6400 ml/kg) died; total mortality rate was 2/20, 3/20, and 4/20 by 24 h, 48 h and 7 days post dose, respectively. No deaths were observed at lower doses. See also Table 2.
Clinical signs:
Clinical symptoms were observed in all dose groups; incidence and severity showed a trend to dose-relationship. Clinical symptoms comprised marked staggering, prone/lateral position with extended extremities, narcosis-like state, dyspnea, chewing movements, high-legged gait, piloerection, and intermittent respiration. Animals recovered quickly; clinical symptoms were reversible at day 3 post-dose (groups 1 and 2) or day 1 post-dose (groups 3 and 4).
Gross pathology:
Pathology of the decedents revealed distended gastro-intestinal tract (1 animal), possible renal changes (1 animal), and putrefaction. Signs of cannibalism were noted for 2 animals.
No pathologic findings were noted in survivors that had been sacrificed at the end of the observation period.

Any other information on results incl. tables

Table 2: mortality

 

group

number

of animals

concentration

in vehicle

[% (v/v)]

applied dose

mortality rate within

[ml/kg bw

[mg/kg bw]

1 h

24 h

48 h

7 d

1

20

30

6400

5440

0/20

2/20

3/20

4/20

2

20

30

3200

2720

0/20

0/20

0/20

0/20

3

20

20

1600

1360

0/20

0/20

0/20

0/20

4

20

2

200

170

0/20

0/20

0/20

0/20

 

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
3-Methyl-3-buten-1-ol was practically nontoxic in rats after ingestion.