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Toxicological information

Acute Toxicity: oral

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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[(acryloyloxy)methyl]butyl acrylate (non-preferred name)
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:
No data
Body weight:
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.