Registration Dossier

Administrative data

Description of key information

ORAL 
LD50, rat > 5440 mg/kg bw (BASF, 1968)
DERMAL
No data are available.
INHALATION
No mortality was observed when 12 rats were exposed for 8 hours to an  atmosphere that had been saturated at 20°C with the volatile parts of the  compound. The nominal concentration of the test substance was 21.5 mg/l. (BASF, 1968)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Qualifier:
equivalent or similar to guideline
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
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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
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
Key result
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.

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

 

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 440 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1968-09-24 (day of exposure)
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.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
BASF Test (internal standard procedure). In principle, the methods described by OECD TG 403 were used.
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
other: Inhalation Risk Test
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no further data
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
This test was in principle performed as described in OECD Guideline 403.

- Temperature chosen for vapour generation: 20°C.

GENERAL PROCEDURE
Two groups of 3 rats per sex were exposed sequentially to the vapours by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for different time periods (e.g. 3 min, 10 min, 1 h, 3 h, 7 h or 8 h). The exposure time not causing lethality was usually tested twice.
No analytical determination of the atmosphere concentration was performed. The nominal concentration can be calculated as quotient of the amount of test substance weight loss during the exposure (given in the raw data) and the amount of air used during exposure.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
21.5 mg/l (atmosphere saturated with vapour)
No. of animals per sex per dose:
totally 12 rats (6 males, 6 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Groupwise documentation of clinical signs was performed over the 7-day observation period. Body weight of groups was determined before the start of exposure and at the end of the observation period in surviving animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LCLo
Effect level:
> 21.5 mg/L air (nominal)
Exp. duration:
8 h
Remarks on result:
other: No deaths at saturated vapour concentration.
Mortality:
All animals survived until the end of the 7-day observation period.
Clinical signs:
other: Irritation of the mucosa and dyspnea was observed during exposure. After termination of exposure, imbalance and, for one animal, narcosis was noted. The animals were normal at one day after exposure.
Gross pathology:
Chronic bronchitis was reported for two animals. No pathological findings were observed in the remaining 10 animals.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
No mortality was observed when 12 rats were exposed for 8 hours to an  atmosphere that had been saturated at 20°C with the volatile parts of the  compound. The concentration of the test substance was 21.5 mg/l (nominal).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

ORAL

In an acute oral toxicity study (BASF 1968), groups of young Sprague-Dawley rats (10/sex) were given a single oral dose of 3 -methyl-3-buten-1-ol (99% pure, emulsified in aqueous Traganth), at doses of ca. 170, 1360, 2720, 5440 mg/kg bw (200, 1600, 3200, 6400 ml/kg bw) and observed for 7 days.

Oral LD50Combined > 5440 mg/kg bw, the highest dose applied

3-Methyl-3-buten-1-ol is of LOW Toxicity based on the LD50in both sexes.

Four out of 20 rats of the highest dose group died; no other deaths were observed. Clinical symptoms were unspecific in nature, were noted at all dose levels and were reversible within 3 days. Pathology revealed changes of the gastrointestinal tract and renal changes in some decedents.

 

DERMAL

No data are available.

INHALATION

In an Inhalation Risk Test (BASF, 1968), totally 12 rats were exposed by inhalation route to an atmosphere that had been saturated at 20°C with the volatile parts of 3-methyl-3-buten-1-ol (99% pure) for up to 8 hours (nominal test concentration: 21.5 mg/l). Animals then were observed for 7 days.

No deaths occurred. Clinical symptoms were limited to irritation of the mucosa, dyspnea, imbalance and, in part, narcosis; animals were normal by day 1 post exposure. Gross pathology revealed chronic bronchitis for 2 individual animals.

3-Methyl-3-buten-1-olis classified as being of LOW Toxicity based on the lack of any adverse, specific observations under the conditions of this test.

Justification for classification or non-classification

There is no need to classify 3 -methyl-3-buten-1-ol for oral toxicity according to the Directive 67/548/EC or GHS criteria.

There is no need to classify 3 -methyl-3-buten-1-ol for acute inhalation toxicity according to the Directive 67/548/EC or GHS criteria.