Tetrahydrofurfuryl acrylate

Endpoint summary

Description of key information

An acute toxicity study by oral route is available on tetrahydrofurfuryl acrylate. The results showed a LD50 of 928 mg/kg in rats indicating that the test substance is harmful after a single administration by oral route.

No acute toxicity study is available by dermal route and inhalation, because tetrahydrofurfuryl acrylate is a skin corrosive substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

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)

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

928 mg/kg bw

Quality of whole database:

The study is considered to be reliable with a klimisch score of 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity :

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).

Justification for classification or non-classification

Based on the oral acute toxicity study, tetrahydrofurfuryl acrylate should be classified as Harmful if swallowed (Acute toxicity 4, H302).

Justification: The oral LD50 is between 300 and 2000 mg/kg (928 mg/kg).