Tetrahydrofurfuryl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrofurfuryl methacrylate

EC Number:

219-529-5

EC Name:

Tetrahydrofurfuryl methacrylate

Cas Number:

2455-24-5

Molecular formula:

C9H14O3

IUPAC Name:

(oxolan-2-yl)methyl 2-methylprop-2-enoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tetrahydrofurfuryl methacrylic acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Inc.
- Weight at study initiation: 172-206 g (males), 187-218 g (females)
- Fasting period before study: yes, 24 h
- Housing: individually in suspended stainless steel cages with stainless steel grid flooring
- Diet (e.g. ad libitum): Purina Rat Chow
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: min 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24-26°C
- Humidity (%): 50%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2.5, 3.75, 5.63, 8.44 g/kg bw

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 weighing: day 0, 14
- Frequency of observations: 1/4, 1/2, 1, 2, 4 h, daily through 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 945 mg/kg bw

Based on:

test mat.

95% CL:

3 121 - 4 986

Mortality:

2.5 g/kg bw:
1/5 females and 0/5 males died

3.75 g/kg bw:
3/5 females and 2/5 males died

5.63 g/kg bw:
5/5 females and 4/5 males died

8.44 g/kg bw:
4/5 females and 5/5 males died

Clinical signs:

other: 2.5 g/kg bw: - decrease in motor activity and decrease in respiratory rate in all animals after 4 h - decrease in motor activity in 6/10 animals on day 1 - decrease in respiratory rate in 1/10 animals on day 1 - hematuria, griping, diarrhea, lachrymose in

Gross pathology:

External examination revealed all animals of the two middle range doses to be lachrymose, which was only observed in 2/7 high dose mortality animals. Internally, most commonly occurring pathologies seen were hepatic discolouration and/or necrosis; hematuria; urinary bladder haemorrhages; gastric intestinal tract injection, haemorrhages, and/or disintegration; pancreatic haemorrhages.
Renal haemorrhages and/or loss of colour were seen commonly in the two highest dose groups.
Other abnormalities observed with less frequency were haemorrhagic thymus (1) and discolouration and/or necrosis of the spleen (3).

Of the 17 surviving animals, only one showed evidence of previous liver damage (3.75 g/kg bw dose group) and another abnormal whitish shean on the spleen (8.44 g/kg bw dose group). All other animals appeared normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The acute oral LD50 of THFMA in rats (male/female) is 3945 mg/kg bw (95% C.I. 3121 – 4986 mg/kg bw).

Executive summary:

In an acute oral toxicity study according to OECD guideline 401 (1981), groups of fasted Sprague Dawley rats (5/sex) were given a single oral dose of THFMA at doses of 2.5, 3.75, 5.63, 8.44 g/kg bw and observed for 14 days.

In the 2.5 g/kg bw dose group 1/5 females and 0/5 males died; in the 3.75 g/kg bw group 3/5 females and 2/5 males died; in the 5.63 g/kg bw group 5/5 females and 4/5 males died; in the 8.44 g/kg bw group 4/5 females and 5/5 males died.

Decrease in motor activity and respiratory rate was commonly observed up to 1 d after administration. Additionally hematuria, griping, diarrhea, lachrymose were found in 1/10 animals on day 1 in the 2.5 g/kg bw dose group.

In the 3.75 g/kg bw dose group griping and lachrymose were observed in 2/10 animals on day 1, and hematuria in 3/10 animals on day 1.

In the 5.63 g/kg bw dose group hematuria was observed in 5/10 animals and lachrymose in 5/10 animals on day 1.

In all dose groups the surviving animals appeared normal from day 2 on.

External examination at revealed all animals of the two middle range doses to be lachrymose, which was only observed in 2/7 high dose mortality animals. Internally, most commonly occurring pathologies seen were hepatic discolouration and/or necrosis; hematuria; urinary bladder haemorrhages; gastric intestinal tract injection, haemorrhages, and/or disintegration; pancreatic haemorrhages.

Renal haemorrhages and/or loss of colour were seen commonly in the two highest dose groups.

Other abnormalities observed with less frequency were haemorrhagic thymus (1) and discolouration and/or necrosis of the spleen (3).

Of the 17 surviving animals, only one showed evidence of previous liver damage (3.75 g/kg bw dose group) and another abnormal whitish shean on the spleen (8.44 g/kg bw dose group). All other animals appeared normal.

 

Oral LD50 Combined = 3945 mg/kg bw (95% C.I.3121 – 4986 mg/kg bw).

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.