Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is a screening test but followed international guidance requirements with acceptable restrictions. The stuy method was similar to the OECD 401 Guideline.
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:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: no certificate of analysis, no necropsy on dead animals, no weighing of dead animals
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
IUPAC Name:
Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
Test material form:
other: Amber liquid
Details on test material:
- Name of test material (as cited in study report): DV-2422N

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: young adult
- Weight at study initiation: male: 216g; female: 206g
- Fasting period before study: overnight prior to dosing
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

IN-LIFE DATES: From: To: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
not applicable as the substance is administered as supplied

MAXIMUM DOSE VOLUME APPLIED: 4-5 mL
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily, weighing prior dosing and at death or at the end of the 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: organ weights, histopatholog: not examined
Statistics:
Calculation of te LD50 and 95% confidence limits by the method of moving averages, using the tables constructed by Weil.

Results and discussion

Preliminary study:
Not applicable: Limit test
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks:
Dose of substance as registered (including residual water necessary for the stability and impurities)
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks:
Dose of substance as registered (including residual water necessary for the stability and impurities)
Remarks on result:
other: 0/5 males died
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Remarks:
Dose of substance as registered (including residual water necessary for the stability and impurities)
Remarks on result:
other: 3/5 females died within 48h of dosing
Mortality:
3 females died within 48 hours of dosing.
Clinical signs:
Animals appeared sickly following dosing.
Body weight:
Males gained weight normally after dosing (mean of 119g for all males) whereas the surviving females gained weight but in a lesser extent (58 and 40 g gained at the end of the observation period for the 2 surviving females).
Gross pathology:
Organs of the thorax and abdomen appeared normal in the survivors.
Other findings:
no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified for acute oral toxicity as the LD50 combined male and female in rat is higher than 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity screening study, performed similarly to the OECD guideline No. 401, a group of Sprague Dawley male and female rats (5 animals/sex) was given a single oral dose of Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide (named as DV-2422N in the study report) by gavage at the dose of  5000 mg/kg bw. The test item was administered as supplied (undiluted). Clinical signs, mortality and body weight gain were checked for a period of up to 14 days.All surviving animals were sacrificed at the end of the study and necropsied for gross abnormalities.

 

Oral LD50 rat combined males and females > 5000 mg/kg bw

 

3/5 females died within 48 hours of dosing whereas no male died. Males gained weight normally after dosing (mean of 119g for all males) whereas the surviving females gained weight but in a lesser extent (58 and 40 g gained at the end of the observation period for the 2 surviving females). Organs of the thorax and abdomen appeared normal in the survivors.

 

Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.