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

Endpoint summary

Description of key information

Glycerol dimethacrylate is of low acute oral toxicity. LD50 is higher than 2000 mg/kg bw in rats. 
Acute oral toxicity: LD50 (rat, combined) > 2000 mg/kg bw; OECD Guideline 423, GLP (Klimisch score = 1)
Acute inhalation toxicity: no relevant route of exposure
Acute dermal toxicity: no adverse effects/ very low systemic toxicity after oral exposure as relevant route of exposure

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

There is one relevant, adequate and reliable study for Glycerol dimethacrylate available (BSL, 1999) (Klimisch score = 1) The test was performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study OECD 423, GLP.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Glycerol dimethacrylate is of low acute oral toxicity.

LD50: > 2000 mg/kg bw (oral rat, OECD 423). The acute oral LD50 is found to be higher than 2000 mg/kg bw in rats in absence of mortality and clinical signs. Therefore Glycerol dimethacrylate has no acute toxic characteristics by oral route (BSL, 1997).

Justification for classification or non-classification

Based on the available oral data LD50 is higher than 2000 mg/kg bw in rats, Glycerol dimethacrylate is not classified according to Annex I of CLP/EU-GHS (1272/2008/EC) and UN GHS.