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Administrative data

Description of key information

The LD50 was greater than 2000 mg/kg bw.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks)
- Weight at study initiation: Animlals of comparable weight (+/- 20% of the mean weight)
- Fasting period before study: at least 16 hours before administration
- Housing:single housing (Makrolon cage, type III)
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: al least 5 days before the beginng o the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histology, pathology
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
In all animals of the first test group reduced defecation was noted on study day 6 while body weight loss was noted on study day 7.
In the second test group no clinical signs were observed during clinical examination.
Body weight:
The body weights of the animals of the first administration group decreased during the first observation week but increased to a normal range during the second week. The body weights of the second test group increased within the normal range throughout the study period with one exception. In one animal the body weight increased normally during the first observation week, but stagnated during the second week.
Gross pathology:
There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose of Isopropylidenglycerolmethacrylate (IPGMA) after oral administration was found to be greater than 2000 mg/kg bw in rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

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

In an acute oral toxicity study performed according to the Acute Toxic Class Method, 2000 mg/kg bw of the undiluted test item Isopropylidenglycerolmethacrylate (IPGMA) were administered by gavage to two test groups of three fasted Wistar rats each (6 females). No mortality occurred. The body weights of the animals of the first 2000 mg/kg bw administration group decreased during the first observation week but increased in a normal range during the second week. The body weights of the second 2000mg/kg bw test group increased within the normal range throughout the study period with one exception. In one animal the body weight increased normally during the first observation week, but stagnated during the second week. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).