Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Range-finding study, test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Guideline:
other: Range-finding test
Principles of method if other than guideline:
Range-finding study
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 90 to 120 gram.
- Fasting period before study: nonfasted
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: undiluted
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.0 ml/kg bw
Doses:
1.25, 2.5 and 5.0 ml/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 334 mg/kg bw
Remarks on result:
other: LD50= 3.54 ml/kg (2.57 to 4.87 ml/kg, oral, rat, original value) Density = 0.94 g/cm³
Sex:
male
Dose descriptor:
LD100
Effect level:
4 700 mg/kg bw
Remarks on result:
other: 5/5 animals died within 2 days
Sex:
male
Dose descriptor:
LD0
Effect level:
2 350 mg/kg bw
Remarks on result:
other: 0/5 animals died
Mortality:
Dosage (ml/kg) died
5.0 5/5 animals
2.5 0/5 animals
1.25 0/5 animals
Clinical signs:
Signs of intoxication at 5.0 ml/kg: sluggish, pilo-erection, heavy breathing - 10 min.
Body weight:
Dosage (ml/kg) mean body weight (g)
I T
5.0 101 -
2.5 96 186
1.25 98 196
Gross pathology:
Dead animals: congestion in the lungs, livers, spleens and kidneys mottled,; kidneys congested; adrenals slightly congested; stomachs distended,
liquid and gas filled pylorus hemorrhaged; intestines distended, gas filled, slightly yellow.
Survivors: no abnormal findings

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information: no Category according REGULATION (EC) No 1272/2008
Conclusions:
Dimethylaminopropyl methacrylamide is not listed in annex VI of REGULATION (EC) No 1272/2008. It is of low toxicity and not classified in the
current EU system. Under UN/OECD GHS the substance is Cat. 5 for acute oral toxicity.
Oral LD50 Males = 3334 mg/kg bw
GHS interpretation of the results yield in no Category for Dimethylaminopropyl methacrylamide.
Executive summary:

In an acute oral toxicity study (Range-finding test), groups of 5 male Harlan-Wistar Albino rats (source: no data, age: no data, weight: 90 to 120 gram), were given a single oral dose of undiluted Dimethylaminopropyl methacrylamide (purity: >=98%) at doses of 1.25, 2.5 and 5.0 ml/kg bw.  Animals were then observed for 14 days.

 

Oral LD50 Males = 3.54 (2.57 - 4.87 ml/kg bw) ml/kg bw (original value) equals 3334 mg/kg bw

 

Dimethylaminopropyl methacrylamide is of low Toxicity based on the oral LD50 in male rats. The substance has no toxicity category according to REGULATION (EC) No 1272/2008 but according to OECD GHS criteria Dimethylaminopropyl methacrylamide has toxicity category V.

There were no treatment related clincal signs, necropsy findings or changes in body weight in surviving animals.

Oral LDL0 Males = 2.5 ml/kg bw

Oral LD100 Males = 5.0 ml/kg bw

This acute oral range-finding study is classified as acceptable. It does satisfy the requirements for an acute oral study in the male rat. 

(NOTE: Any of the data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the sense of a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities, who have paid the respective access fee for the intended purpose.)