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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-05-23 to 1997-04-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-bis(vinyloxy)butane
EC Number:
223-437-0
EC Name:
1,4-bis(vinyloxy)butane
Cas Number:
3891-33-6
Molecular formula:
C8H14O2
IUPAC Name:
1,4-bis(ethenyloxy)butane

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, BIBERACH, Germany
- Age at study initiation: Young adult animals of a comparable weight were used
- Weight at study initiation: males 180 - 183 g, females 169 - 171 g
- Fasting period before study: 16 hours prior to administration (but water ad libitum)
- Housing: Five animals per cage (type: stainless steel wire mesh cages, DK-III), no bedding
- Diet: KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG KAISERAUGST, SWITZERLAND, as libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data, however housing in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 1996-05-14 (day of first administration, before at least one week acclimatisation) To: 1996-05-23 (day of last administration)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bidest
Details on oral exposure:
The aqueous test substance formulation corresponds to the physiological medium.
Form of administration: emulsion

VEHICLE
- Concentration in vehicle: 20 g / 100 mL
- Amount of vehicle: 10 mL
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium
- Purity: bidest water was used

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/ kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: A check for dead and moribund animals was made twice on workdays and once on the other days. Weighing of both groups on day 0, day 7; on day 13 (males) and day 14 (females).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, impaired general state, poor general state, dyspnoea, apathy, staggering, piloerection, salivation, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: Males only: impaired or poor general state, dysponea, apathy, staggering, salivation. These symptoms are considered to be unspecific toxicity symptoms. The animals appeared normal one day after administration.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion