4-(vinyloxy)butan-1-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 OECD Guideline 402 (Acute Dermal Toxicity) with acceptable restrictions mostly due to reduced documentation and no GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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/colorless
- Analytical purity: >99%
- Lot/batch No.: Barrel 1
- Expiration date of the lot/batch: not reported
- Stability under test conditions: at least for the study period
- Storage condition of test material: refrigerator

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: 200-300 g, mean weight for males- 271 g and females -230 g.
- Housing: single
- 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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 50 cm2
- Type of wrap if used: Porous dressing (Four layers absorbent guaze and porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing of the application site with warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.12 ml/kg bw
- Density (g/ml): 0.944

Duration of exposure:

24 h

Doses:

2000 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: symptoms were recorded several times on the day of application and at least once each workday. Check for moribond and dead animals was performed twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, pathology, scoring of skin findings

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No pathological changes were observed.

Other findings:

No local findings were observed.

Applicant's summary and conclusion

Executive summary:

The study was performed as limit test comparable to OECD Guideline 402 (Acute Dermal Toxicity) with acceptable restrictions mostly due to reduced documentation and no GLP. The only test dose of 2000 mg/kg bw did not cause mortality, symptoms or necropsy findings.

Conclusion: 4-(vinyloxy)butan-1 -ol is practically non-toxic after dermal application.