Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted according to an appropriate OECD guideline and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tetrahydro-2-methylfuran

- Physical state: clear colourless liquid

- Storage condition of test material: room temperature in the dark under nitrogen

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan laboratories, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: not specified
- Fasting period before study: overnight and until 3-4 hours after doswing
- Housing: In groups of 4, in suspendedsolid-floor polypropylene cages, furnished with woodflakes.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:
300, 2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw, 1 female
300 mg/kg bw, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and daily for up to 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on day 0 and on days 7 and 14 or at death. Due to a technician error, the body weight at death was not recorded for the animal treated at a dose level of 2000 mg/kg that was humanely killed.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Necropsy consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities were recorded. No tissues were retained.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 mg/kg bw
Based on:
test mat.
Mortality:
The animal dosed at the 2000 mg/kg dose level was killed for humane reasons thirty minutes after dosing, due to the occurrence of clinical signs of toxicity which exceeded the severity limit set forth in the UK Home Office Project License. There were no deaths at the 300 mg/kg dose level.
Clinical signs:
Signs of systemic toxicity noted thirty minutes after dosing at the 2000 mg/kg dose level were laboured respiration, decreased respiratory rate, hypothermia and pallor of the extremities. The animal was also comatose. No signs of systemic toxicity were noted during the observation period at the 300 mg/kg dose.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
Haemorrhage and epithelial sloughing of the non-glandular epithelium of the stomach and clear fluid present in the stomach were noted at necropsy of the animal treated at a dose level of 2000 mg/kg. No abnormalities were noted at necropsy in the animals dosed at 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 was estimated to be in the range of 300 - 2000 mg/kg bodyweight, as determined in a reliable study conducted according to current OECD guideline and in compliance with CLP.