4-(vinyloxy)butan-1-ol

Acute Toxicity: oral

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: Study is comparable to guideline with acceptable restrictions mostly due to reduced documentation and no GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(vinyloxy)butan-1-ol

EC Number:

241-793-5

EC Name:

4-(vinyloxy)butan-1-ol

Cas Number:

17832-28-9

Molecular formula:

C6H12O2

IUPAC Name:

4-(ethenyloxy)butan-1-ol

Details on test material:

- Name of test material (as cited in study report): Vinyl-4-Hydroxybutylether
- Physical state: liquid
- Analytical purity: approximately 100%
- Expiration date of the lot/batch: April 1984
- Stability under test conditions: not reported
- Storage condition of test material:not reported

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach
- Weight at study initiation: 179-218 g (male), 171-196 g (female)
- Fasting period before study: no food was given 16 h before application
- Housing: 5 per cage
- Diet: Kliba Laboratory diet 343 (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 (6:00-18:00 hrs/18:00-6.00hrs)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle (%): 21.50, 17.80, 14.70, 10.00, 4.64
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: aqueous solution corresponds to physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 2.18 ml for males and 1.96 ml for females

Doses:

2150, 1780, 1470, 1000 and 464 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were observed many times on the day of application and daily after application. The animals were weighed before and on day 3, 4, 6, 7 and 13 after application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

LD50 was calculated after Finney DJ Probit Analysis, Cambridge University Press, 3rd Ed, 1971.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 780 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 540 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 738 mg/kg bw

Mortality:

2150 mg/kg bw: 5/5 females, 5/5 males within 1 day.
1780 mg/kg bw: 3/5 females, 2/5 males within 1 day.
1470 mg/kg bw: 1/5 female, 0/5 male within 1 day.
1000 mg/kg bw: 1/5 female, 0/5 male within 1 day.
464 mg/kg bw: no mortality was observed.

Clinical signs:

other: 464 mg/kg bw: within 30 min after administration, dyspnoea, apathy, staggering gait, ruffled fur and poor general condition was observed. No signs were observed after 4 h. 1000 mg/kg bw and higher: within 15 min after administration, dyspnoea, apathy, abn

Gross pathology:

Congestion and hyperemia were observed in the heart of deceased animals. No changes were observed in sacrificed animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

This study is comparable to OECD 401 with acceptable restrictions mostly due to reduced documentation and no GLP. Groups of 5 rats per sex and dose group were administered with 2150, 1780, 1470, 1000 and 464 mg/kg bw of the test substance. The acute LD50 of the test substance in rats was found to be 1738 mg/kg bw for male and female animals. Within 30 min after administration, dyspnoea, apathy, staggering gait, ruffled fur and poor general condition was observed even in the lowest dose group. No signs were observed after 4 h. In the higher dose groups, dyspnoea, apathy, abnormal position, staggering gait, atony, loss of pain and corneal reflex, narcosis like condition, ruffled fur, cyanosis, dehydration and poor general condition was observed. No signs were observed 2 day after administration, except ruffled fur was noted in 1000 and 1470 mg/kg bw dose group till three and 6 day, respectively. Substance caused congestion and hyperemia in animals that died.

Conclusion: 4-(vinyloxy)butan-1 -ol is harmful after oral administration (GHS cat. 4)