2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Principles of method if other than guideline:

An acute oral toxicity study was performed in Sprague-Dawley rats. Test material was administered at 6 graduated doses and observations were made for a period of 14 d.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate

EC Number:

239-701-3

EC Name:

2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate

Cas Number:

15625-89-5

Molecular formula:

C15H20O6

IUPAC Name:

2,2-bis(prop-2-enoyloxymethyl)butyl prop-2-enoate

Constituent 2

Reference substance name:

Trimethylolpropane Triacrylate (TMPTA)

IUPAC Name:

Trimethylolpropane Triacrylate (TMPTA)

Details on test material:

- Physical state: Clear colourless liquid
- Other: BRL No. 590A

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Flow Laboratories
- Fasting period before study: Yes, overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 5 % Acacia for 50, 127.5 & 315.1 mg/kg bw doses

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 % suspensions stabilized in 5 % Acacia (for 50, 127.5 & 315.1 mg/kg bw doses); other doses were given undiluted.

Doses:

50.0, 127.5, 315.1, 785, 1999, 5000 mg/kg bw

No. of animals per sex per dose:

5 rats/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed frequently during the first 4 h, and at least daily thereafter for 14 d

Statistics:

Not applicable

Results and discussion

Preliminary study:

Not applicable

Effect levels

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortalities were observed, except 2 animals died at dose level of 5000 mg/kg bw

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

Table1.Summary of mortality data

Dose Level mg/kg bw	Number Dead/ Number Tested
50.0	0/5
127.5	0/5
315.1	0/5
795.0	0/5
1999	0/5
5000	2/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of the test substance (trimethylolpropane triacrylate - TMPTA) in rats was calculated to be > 5000 mg/kg bw. Therefore, no classification is required according to EU criteria.

Executive summary:

A study was conducted to assess the single dose toxicity of the test substance (trimethylolpropane triacrylate - TMPTA) in Sprague-Dawley rats using the standard acute method.

Groups of 5 Sprague-Dawley rats/dose (sex unspecified) received a single oral (gavage) dose of 50.0, 127.5, 315.1, 785, 1999, 5000 mg/kg. The test substance (trimethylolpropane triacrylate - TMPTA). The three lower doses were administered as 10% suspensions stabilized by the incorporation of 5% acacia, while the three higher doses were administered undiluted. Parameters evaluated included survival and clinical observations on the day of dosing and at least daily thereafter for 14 d.

No mortalities were observed except in two of the five animals in the 5000 mg/kg bw group.

In conclusion, the single oral median lethal dose (LD50) of the test substance (trimethylolpropane triacrylate - TMPTA) in rats was calculated to be >5000 mg/kg bw.