Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21.05.2013 to 17.07.2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of Glycerin formal and 2-Propenoic acid, 2-methyl-, methyl ester
EC Number:
945-527-5
Cas Number:
1620329-57-8
Molecular formula:
C8H12O4
IUPAC Name:
Reaction products of Glycerin formal and 2-Propenoic acid, 2-methyl-, methyl ester
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
WISTAR Crl: WI(Han) rats
Sex:
female
Details on test animals or test system and environmental conditions:
Species/strain: healthy rats, WIST AR rats Cr!: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Number of animals: 3 per step I 2 steps performed
Age at the beginning of the study: 8 - 9 weeks old
Bodyweight on the day of ac!rnmistration:
Step 1 / animals no, 1 - 3: 151- 159 g
Step 2 / animals no. 4 - 6: 137 -149 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test
item was suspended in the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days for general clinical signs, morbidity and mortality.
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes: All animals were subjected to gross necropsy. All gross pathological changes were recorded and in case of findings the tissues were preserved for a possiblen histopathological evaluation.
- Other examinations performed: A careful clinical examination was made several times on the day of dosing ( at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. 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, dianhoea, lethargy, sleep and coma.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Remarks:
unclassified
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off (rat): unclassified
Mortality:
no mortality was observed
Clinical signs:
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, moving the bedding and half eyelidclosure.
All symptoms recovered within up to 1 days post dose.
Body weight:
Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.
Gross pathology:
At necropsy, no macroscopic findings were observed in any animal of any step.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, a single oral application of the test item Glycerinformal methacrylate to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but no mortality.
The median lethal dose of Glycerinformal methacrylate after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item Glycerinformal methacrylate has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item Glycerinformal methacrylate has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item Glycerinformal methacrylate has no obligatory labelling requirement for toxicity and is not classified.
Executive summary:

In an acute oral toxicity study according to OECD guideline 423 (acute toxic class method), two groups of each 3 female Wistar rats were given a single oral (gavage) dose of Glycerolformal methacrylate at a dose of 2000 mg/kgbw and observed for 14 days.

The test item was suspended in the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.

All animals survived until the end of the study showing signs of toxicity. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, moving the bedding and half eyelidclosure. All symptoms recovered within up to 1 days post dose. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step.

The median lethal dose of Glycerinformal methacrylate after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): unclassified

In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item Glycerinformal methacrylate has no obligatory labelling requirement for toxicity.

According to Annex I of Regulation (EC) 1272/2008 the test item Glycerinformal methacrylate has no obligatory labelling requirement for toxicity and is not classified.

According to GHS (Globally Harmonized Classification System)  the test item Glycerinformal methacrylate has no obligatory labelling requirement for toxicity and is not classified.

Categories Display