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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August - September 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1993
Deviations:
yes
Remarks:
Change in body weight range of test animals at start of treatment
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrofurfuryl acrylate
EC Number:
219-268-7
EC Name:
Tetrahydrofurfuryl acrylate
Cas Number:
2399-48-6
Molecular formula:
C8H12O3
IUPAC Name:
tetrahydrofuran-2-ylmethyl acrylate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: kleintierfarm Madoerin AG, CH4414 Fuellinsdorf/ Switzerland
- Age at study initiation: 9-13 weeks
- Weight at study initiation: males = 168-298 g ; females = 146-213 g
- Fasting period before study:
- Housing: groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2% in distilled water
Details on oral exposure:
The animals received the test article on a mg/kg bw base by oral gavage after being fasted for 12 to 18 hours (access to water not interrupted). Food was again presented approximately one hour after dosing.
Volume application : 10 ml, except at the dose of 5000 mg§kg (20 ml)
Doses:
600, 1000, 2000, 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The test article was placed info a glass beaker on a tared balance and the vehicle was added. A weight by volume suspension was prepared using a homogenizer.
Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparations were made immediately prior to each dosing.

- Duration of observation period following administration: 15 days
- Frequency of observations (mortality and clinical signs): four times during test day 1, and daily during days 2-15
- Frequency of weighing: test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
Statistics:
The LOGIT-Model was applied to estimate the LD50 value. Additionally, the 90, 95 and 99% confidence intervals for the LD50 for each sex and the slope of the concentration response line was estimated.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
928 mg/kg bw
Based on:
test mat.
95% CL:
708 - 1 183
Sex:
male
Dose descriptor:
LD50
Effect level:
1 002 mg/kg bw
Based on:
test mat.
95% CL:
> 634 - < 1 462
Sex:
female
Dose descriptor:
LD50
Effect level:
882 mg/kg bw
Based on:
test mat.
95% CL:
> 344 - < 1 468
Mortality:
600 mg/kg = 1/10 : no mortality in males (0/5), 1 female died at day 7.
1000 mg/kg = 6/10 : 3/5 dead males, on day 2. 3/5 dead females: 2 animals 5h after administration, and one animal at day 2.
2000 mg/kg = 10/10: 5/5 dead males : 1 animal 3 hr after administration, 3 animals 5hr after, and 1 animal at day 2. 5/5 dead females: one female 3hr after administration, 2 females 5h after, and 2 females at day 2.
5000 mg/kg = 10/10 : 5/5 dead males: 1 animal 2 hr after administration, 3 animals 3hr after, and 1 animal 5hr after. 5/5 dead females: one female 2 hr after administration, and 4 females 3 hr after.
Clinical signs:
other: 600 mg/kg: sedation, abdominal position, curved body position (females), ruffles fur. 1000 mg/kg: sedaction, exophthalmos, emaciation (females), ruffled fur. 2000 mg/kg: sedaction, exophthalmos,abdominal position, curved body position, ruffled fur. 5000 m
Gross pathology:
600 mg/kg: cannibalism (dead), no change in killed animals.
1000 mg/kg: in dead animals, stomach filled with test article (severe), dark-red discolor small intestine. In killed animals: reddened slight small intestine.
2000 mg/kg: Stomach filled with test article (severe); stomach enlarged, severe, filled with test article ; dark-red discolored intestines; slight and reddened small intestines; abdominal cavity filled with clear fluid (2 ml).
5000 mg/kg: Stomach filled with test article (severe)

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the experimental data, the acute oral LD50 of tetrahydrofurfurylacrylate in rats of both sexes observed for a period of 15 days is 928 mg/kg.
Executive summary:

The test article Tetrahydrofurfurylacrylate was administered to rats of both sexes by oral gavage at doses from 600 to 5000 mg/kg bw. Five males and five females were exposed by dose. The following death rate was observed : 10% at 600 mg/kg, 60% at 1000 mg/kg, 100% at 2000 and 5000 mg/kg. Based on these data, the Logit-estimation for the acute oral LD50 of tetrahydrofurfurylacrylate in rats of both sexes observed for a period of 15 days is 928 mg/kg (males: 1002 mg/kg, females : 882 mg/kg).