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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Reference substance name:
(RS)-(3-aminoethyl) tetrahydrofuran
IUPAC Name:
(RS)-(3-aminoethyl) tetrahydrofuran
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): (RS)-(3-aminoethyl) tetrahydrofuran (FAM)
- Physical state: clear liquid
- Analytical purity: 99.8%
- Lot/batch No.: MAP61-068

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan U.K. Ltd, Bicester, Oxon, England
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 93 - 105 g
- Housing: in groups of 5 rats per cage
- Diet (e.g. ad libitum): ad libitum (Special Diet Services RM1(E) SQC expanded pellet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 22.5 °C
- Humidity (%): 41 - 63 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
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: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One female died within four hours of dosing. Macroscopic examination of this animal revealed congestion (characterised by darkened tissues/organs, prominent blood vessels or enlarged, swollen or thichended tissues) in the subcutaneous tissue, brain and heart. Congestion and fluid contents were also noted in the stomach and along the alimentary tract.
Clinical signs:
other: Piloerection was observed in all rats soon after dosing. This sign persisted and was accompanied in all animals by salivation, abnormal gait and hunched posture. In addition, lethargy, reduced body temperature, thin appearance, ungroomed appearance, prost
Gross pathology:
Macroscopic examination of the surviving animals killed at study termination (Day 15) revealed adhesion of the liver to the thoracic/abdominal wall with atrophy of the kidneys and stomach. Congestion (characterised by prominent blood vessels and enlarged, swollen or thickened tissues) was also noted in the stomach and along the alimentary tract.

Any other information on results incl. tables

Mortality date (main study)

Sex

No of deaths in group of 5

Day*

1

2 to 14

1h

2h

3h

4h

a         b

Male

 

 

 

 

 

 

Female

 

 

 

 

1

 

a First observation

b Second observation

 * The day/hour indicated is the time that the animals was observed to die or found dead

Applicant's summary and conclusion