Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28.09.1999 to 02.11.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0

EC Number:

931-227-1

Cas Number:

28497-59-8

Molecular formula:

C11H16O5

IUPAC Name:

Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0

impurity 1

Reference substance name:

2,3-dihydroxypropyl methacrylate

EC Number:

227-642-6

EC Name:

2,3-dihydroxypropyl methacrylate

Cas Number:

5919-74-4

Molecular formula:

C7H12O4

IUPAC Name:

2,3-dihydroxypropyl methacrylate

impurity 2

Reference substance name:

Glycerol trimethacrylate

EC Number:

231-004-2

EC Name:

Glycerol trimethacrylate

Cas Number:

7401-88-9

Molecular formula:

C15H20O6

IUPAC Name:

propane-1,2,3-triyl tris(2-methylacrylate)

impurity 3

Reference substance name:

oxybis(propane-2,1,3-triyl) tetrakis(2-methylacrylate)

Molecular formula:

C22H30O9

IUPAC Name:

oxybis(propane-2,1,3-triyl) tetrakis(2-methylacrylate)

impurity 4

Reference substance name:

Benzyl methacrylate

EC Number:

219-674-4

EC Name:

Benzyl methacrylate

Cas Number:

2495-37-6

Molecular formula:

C11H12O2

IUPAC Name:

benzyl methacrylate

impurity 5

Reference substance name:

Methacrylic acid

EC Number:

201-204-4

EC Name:

Methacrylic acid

Cas Number:

79-41-4

Molecular formula:

C4H6O2

IUPAC Name:

2-methylprop-2-enoic acid

additive 1

Reference substance name:

Mequinol

EC Number:

205-769-8

EC Name:

Mequinol

Cas Number:

150-76-5

Molecular formula:

C7H8O2

IUPAC Name:

4-methoxyphenol

Test material form:

liquid

Specific details on test material used for the study:

Batch No. 790703330
Lot No.: 32079184
Reactive ester content: 96.9%
Glycerol dimethacrylate: 90.5%
Glycerol trimethacrylate: 1.5%
Storage: room temperature, protected from light
Stability: 6 months from date of delivery
Expiry Date: 99-09-09

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Hsd:Wistar rats (HsdBrl:WH,Full-Barrier), Sex: male and female, body weight at the commencement of the study: female 143 - 155 g and male 154 - 168 g. 3 male and 3 female animals were used.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item 'vas administered in a single dose by gavage using a intubation cannula.
Volume of application: The test item was applied according to body-weight at a volume of 10ml/kg BW.

Doses:

The starting dose was 2000 mg/kg body weight. Since no presence of compound-related mortality of the animals was observed no further testing was required.

No. of animals per sex per dose:

Two groups of 3 male and 3 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed prior to first application and once a week thereafter. A careful clinical examination was made twice a day on the day of dosing
and once a day thereafter. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined.
Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no effects observed

Clinical signs:

no effects observed

Body weight:

no effects observed

Gross pathology:

no effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item Glycerol dimethacrylate has no acute toxic characteristics.
The LD50 was determined to be > 2000 mg/kg bw; no clinical signs or body weight effects were observed..

Executive summary:

In an acute oral toxicity study according to OECD guideline 423 (acute toxic class method), a group of male and female Wistar rats were given a single oral (gavage) dose of Glycerol dimethacrylate at a dose of 2000 mg/kg bw and observed for 14 days.

 

A careful clinical examination was made once a day. At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes.

A maximum dosage of 2000 mg/kg bw according to the acute toxic class method regime, caused no compound related mortality within 14 days post application. No clinical signs of toxicity were observed throughout the observation period.

 

Therefore the oral LD50 (combined) was determined to be > 2000 mg/kg bw.