Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

When a fixed slope of 8.333 was assumed the acute median lethal oral dose of isopropyl acrylamide and its 95% confidence limits were estimated to be:

Males and females combined: 383 (322 to 454) mg/kg bodyweight

Males only: 383 (300 to 487) mg/kg bodyweight

Females only: 383 (300 to 487) mg/kg bodyweight

Based on the conclusion the final LD50 value is concluded as 383 mg/kg/day.

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
Study period:
31 January 1990 - 20 February 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: GLP, The United Kingdon Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
Qualifier:
according to guideline
Guideline:
other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Health and Welfare Nitification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amandment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
Qualifier:
according to guideline
Guideline:
other: OECD ISBN 92-64-12367-9, Paris 1982
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity: 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 108 - 150 g
- Housing: in groups up to 5 rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days prior to the start of the main study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22 °C
- Humidity (%): Mean 58 %RH
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours
Route of administration:
other: Syringe and plastic catheter
Doses:
Preliminary study:
groups of two male asnd female rats were dosed at 400 and 1000 mg/kg
Main study:
groups of five male asnd female rats were dosed at 250, 400 and 640 mg/kg
No. of animals per sex per dose:
Preliminary study:
2 rats per sex per dose
Main Study:
5 rats per sex per dose
Details on study design:
- Duration of observation period following administration: 5 and 14 days
- Frequency of observations and weighing: twice a day (morning and at the end of the experimental day)
- Necropsy of survivors performed: yes
Statistics:
The data obtained from this study did not permit the fitting of a probit line using the standard method. However, it was possible to fit a line if a fixed slope was assumed; a value of 8.333 (estimated from background data which consisted of the average slope for all LD50's carried out in the Department of Industrial Toxicology over a period of one year) was used. Confidence intervals using this approach should be interpreted as minimum intervals since uncertainty in extimatimg the slope is not allowed for.
Preliminary study:
Results of the preliminary study indicated that the acute median lethal oral dose to male and female rats of isopropyl acrylamide was between 400 and 1000 mg/kg bodyweight.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
383 mg/kg bw
Based on:
test mat.
95% CL:
> 322 - < 454
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
383 mg/kg bw
Based on:
test mat.
95% CL:
> 300 - < 487
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
383 mg/kg bw
Based on:
test mat.
95% CL:
> 300 - < 487
Mortality:
There was no deaths following a single oral dose of isopropyl acrylamide at 250 mg/kg bodyweight. However, motrality was seen among rats of both sexes at 400 mg/kg and above. Deaths occured within 22 hours to within 33 hours of dosing.
Autopsy of rats that died during the study reealed no macroscopic abnormalities.
Clinical signs:
Pilo-erection was observed in all raths within five minutes of dosing and throughout the remainder of Day 1. This finding was accompaanied by:
abnormal body carriage, abnormal gain, lethargy, decreased respiration rate and ptosis in all rats;
pallor of the extremities in a majority of rats dosed at 400 mg/kg;

Signs observed from Day 2 onwards included:
body themors and straub tail in a majority of rats dosed at 250 and 400 mg/kg;
patting movement (following disturbance) in two males and one female rat dosed at 250 and 400 mg/kg;
restricted movemetn of the hind quarters, hypersensitivity and aggressive behaiour in a minority of rats dosed at 400 mg/kg
Body weight:
Slightly low body weight gains were recorded for one male rat dosed at 250 mg/kg and two males and one female rat dosed at 400 mg/kg on Day 8. All other rats that survived treatment achieved anticipated bodyweight gains throughout the study.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
When a fixed slope of 8.333 was assumed the acute median lethal oral dose of isopropyl acrylamide and its 95% confidence limits were estimated to be:
Males and females combined: 383 (322 to 454) mg/kg bodyweight
Males only: 383 (300 to 487) mg/kg bodyweight
Females only: 383 (300 to 487) mg/kg bodyweight
Executive summary:

Based on the conclusion the final LD50 value is concluded as 383 mg/kg/day.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
383 mg/kg bw

Additional information

Justification for classification or non-classification

According to the CLP regulation substance which have an LD50 between 300 -2000 mg/kg should be assigned am acute oral hazard category 4 -Harmful if swallowed.

The LD50 value for the test substance NIPAM is 383 mg/kg therefore the acute oral classification is Acute Oral-Category 4: H302: Harmful if swallowed.