Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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-study
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethylaminopropyl Methacrylamide
- Molecular weight (if other than submission substance): 170.25 g/mol

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2166 - 2322 grams
- Fasting period before study: no data
- 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

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin of trunk
- % coverage: no data
- Type of wrap if used: no data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.25, 2.5, 5.0, 10.0 ml/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: no
Doses:
1.25, 2.5, 5.0, 10.0 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
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 355 mg/kg bw
Remarks on result:
other: LD50= 2.50 ml/kg (1.19 to 5.24 ml/kg, dermal, rabbit, original value) Density = 0.94 g/cm³
Sex:
male
Dose descriptor:
LD0
Effect level:
1 175 mg/kg bw
Remarks on result:
other: 0/5 animals died
Mortality:
Dosage (ml/kg) died
10.0 3/5 animals
5.0 3/5 animals
2.5 3/5 animals
1.25 0/5 animals
Clinical signs:
Signs of intoxication: sluggish
Body weight:
Dosage (ml/kg) mean body weight (g)
I T
10.0 2259 2320
5.0 2322 2704
2.5 2166 2196
1.25 2294 2562
Gross pathology:
Lungs, livers, spleens and kidneys congested; livers mottled.

Any other information on results incl. tables

Skin irritation: erythema and spotty areas of edema and/or necrosis.

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 dermal toxicity.
Oral LD50 male rabbits = 2355 mg/kg bw
GHS interpretation of the results yield in no Category for Dimethylaminopropyl methacrylamide.
Executive summary:

In an acute dermal toxicity study (Range-finding test), groups of 5 male Albino rabbits (source: no data, age: no data, weight: 2166 to 2294 grams), were given a single dermal dose of undiluted Dimethylaminopropyl methacrylamide (purity: >=98%) at doses of 1.25, 2.5, 5.0 and 10.0 ml/kg bw.  Animals were then observed for 14 days.

 

Dermal LD50Males = 2.50 (1.19 - 5.24 ml/kg bw) ml/kg bw (original value) equals 2355 mg/kg bw

 

Dimethylaminopropyl methacrylamide is of lowToxicity based on the dermal LD50in male rabbits. 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.

Dermal LDL0 Males = 1.25 ml/kg bw

Dermal LD100Males = > 10.0 ml/kg bw

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