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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 1988-3 Aug 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) 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 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
other: Inhalation hazard test
Limit test:
no

Test material

Constituent 1
Chemical structure
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
- Age at study initiation: 8-9 weeks
- Mean weight at study initiation: 201 g (male), 269 g (female)
- Housing: 3 per cage
- Diet: Kliba 24-343-4 rat/mouse Laboratory diet, 10 mm pellets (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum in the period without exposure.
- Water: ad libitum in the period without exposure
- Acclimation period: 5 days


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


Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The product was introduced to a height of 5 cm into a glass bottle (generator) with a sintered glass disk (pore-size 90 - 150 µm, diameter 30 mm), and the weight was determined.
The generator containing the product was placed in a waterbath maintained at 20°C by a thermostat, and a stream of 200 l/h compressed air was supplied to a downstream mixing chamber. The mixture of air and test substance generated in this way was passed through a glass distributor to 6 glass tubes in which 3 male and 3 female animals had been placed. The emerging mixtures of test substance and air were exhausted.
The temperature in the exposure apparatus was between 19 and 25°C. After 30 minutes, the generator was replaced by a new one containing fresh test substance as described above. This generator was then used for the remainder of the test.

Determination of the nominal concentration:
The amount of test substance used was determined by reweighing the generators. The nominal concentration was calculated from the amount of test substance consumed and the air volume.


Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
0.86 mg/l
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical examinations each work day and lethality each day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, grosspathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IHT
Remarks on result:
other: No mortality was observed after 7 h exposure
Mortality:
No mortality was observed.
Clinical signs:
other: During exposure, accelerated respiration, snout wiping and trembling was observed. No clinical signs were observed after exposure and during the post exposure observation period.
Gross pathology:
No pathological findings were noted.

Applicant's summary and conclusion

Executive summary:

This study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions mostly due to reduced documentation and no GLP. Six rats (3 males and 3 females) were exposed for 7 hrs to a vapour saturated atmosphere at mean concentration of 0.86 mg/L.

No mortality was observed. Animals showed accelerated respiration, snout wiping and trembling during exposure. No clinical signs were observed after exposure and during the post exposure observation period. No pathological changes were observed at necropsy.

Conclusion: Inhalation of 0.86 mg/L 4-(vinyloxy)butan-1 -ol for 7 hrs is practically non toxic.