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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 dermal toxicity study was performed in albino rabbits. The test material was applied topically via a 24 h occlusive patch and observations were made for a period of seven days.

GLP compliance:

no

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:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: Rubber dam, held in place by tape.
- Other: Animals were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified and in half of the animals the area was lightly abraded.


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

0.315, 0.795, 1. 99 and 5.0 mL/kg bw

No. of animals per sex per dose:

4 per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 d
- Necropsy of survivors performed: Yes

Statistics:

No data

Results and discussion

Preliminary study:

No

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 4.7 mL/kg bw

Remarks on result:

other: equivalent to 5170 mg/kg bw assuming density of test material as 1.1 g/mL

Mortality:

One each in 1.99 and 5.0 mL/kg bw dose groups

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

- Other observations (skin irritation): In some cases, the test material caused no erythema or edema, but in others caused severe effects.

Any other information on results incl. tables

Table 1: Number of observed mortalities:

Dosage (mL/kg bw)	Mortality
0.315	0/4
0.795	0/4
1. 99	1/4
5	1/4

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be 4.7 mL/kg bw (i.e. 5170 mg/kg bw) in rabbits. Therefore no classification is required according to the EU CLP criteria.

Executive summary:

A study was conducted to evaluate the acute dermal toxicity of the test substance (trimethylolpropane triacrylate - TMPTA) in rabbits.

Sixteen albino rabbits were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified and in half of the animals the area was lightly abraded. After weighing the animal, the calculated dose was applied and the entire area covered with a rubber dam, held in place by tape. The dose levels applied were 0.315, 0.795, 1.99 and 5.0 mL/kg bw the test substance (trimethylolpropane triacrylate - TMPTA).

Four animals were included in each dose group. 24 h later, the binders were removed and an effort made to remove any remaining material from the skin surface. A score of the local effects, according to the method of Draize, was recorded. The animals were observed repeatedly for seven days at the end of which time they were killed and necropsy was performed.

One mortality was observed at dose levels 1.99 and 5.0 mL/kg bw. In some cases, the test substance (trimethylolpropane triacrylate - TMPTA)

caused no erythema or edema, but in others caused severe effects.

In conclusion, the single dermal median lethal dose (LD50) of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be 4.7 mL/kg bw (i.e. 5170 mg/kg bw) in rabbits.