Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-169-7 | CAS number: 4223-03-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
There are there studies available, two in mice and one in rats that give an indication of the acute oral LD50, this is sufficient for classification and labeling. Extremely low dermal penetration testing indicates that acute dermal toxicity would be low and certainly lower than oral toxicity. Inhalation data is not available but not required due to low potential for exposure via inhalation in industrial use of the substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Used four mice per dose level with four dose levels
- GLP compliance:
- no
- Test type:
- other: Calssical LD50 according to method of Weil (1952)
- Species:
- mouse
- Strain:
- other: ddY strain
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male mice 5-6 weeks of age, 29+/- 2.2 g bodyweight
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Doses:
- Not specified
- No. of animals per sex per dose:
- 4 males
- Control animals:
- not specified
- Statistics:
- Weil CS (1952) Tables for convienient calculation of medial effective dose (LD50 or ED50) and instructions for their use. Biometrics 8: 249-263
Reference
Oral LD50 calculated as 6.6 mmol/kg with 95% confidence interval (3 -1 - 9.2). Based on the molecuilar weight of 183.29 this was 1210 mg/kg.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 210 mg/kg bw
- Quality of whole database:
- The data set is of acceptable quality to allow for the correct classification of the product under the EU CLP (GHS) criteria.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The lack a data is acceptable as there is very low possibility of inhalation exposure within the European Union. As N-(1,1,3,3-tetramethylbutyl)acrylamide is only handled incorporated in polymers.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The data set is of acceptable quality to allow for the conclusion that N-(1,1,3,3-tetramethylbutyl)acrylamide would not be classified under the EU CLP (GHS) criteria for acute dermal toxicity.
Additional information
There are there studies available, two in mice and one in rats that give an indication of the acute oral LD50, this is sufficient for classification and labeling. The physical chemical properties of the N-(1,1,3,3-tetramethylbutyl)acrylamide, mean that significant inhalation exposure is not expected so acute inhalation toxicity testing is not justified or required. The extremely low dermal absorption indicated that acute dermal toxicity would be low and based on the oral data below the level requiring classification under the EU CLP (GHS) criteria.
Justification for selection of acute toxicity – oral endpoint
As well as the accurate oral LD50 in mice of 1210mg/kg there is data from a dose ranging study with repeat doses in rats up to 1000mg/kg. Based on this study the oral LD50 can be estimated to be greater than 500 mg/kg day and less than 1000 mg/kg/day. Also in the dose range finding for the mouse micronucleus study the results indicated an oral LD50 value between 700 and 800 mg/kg. All these values indicate an oral LD50 in the classification range of EU CLP (GHS) Category 4.
Justification for selection of acute toxicity – inhalation endpoint
N-(1,1,3,3-tetramethylbutyl)acrylamide CAS 4223-03-4 has a relatively low vapour pressure of 0.0636 Pa at 20 °C. Its use as a monomer outside the European Union where it is handles as a solution in ethanol has very little potential for inhalation exposure. Data is available for acute oral exposure which indicates only moderate acute toxicity.
Justification for selection of acute toxicity – dermal endpoint
N-(1,1,3,3-tetramethylbutyl)acrylamide CAS 4223-03-4 has been shown to only penetrate human skin very slowly with rats showing three times the rate but still only 0.3% was measured. We have sufficient information for acute oral toxicity for classification and labeling and while we have no data on oral absorption it can be assumed to be significantly higher than dermal absorption. Therefore based on the Oral LD50 in mice of 1210mg/kg acute dermal toxicity would be expected to well above 2000mg/kg
Justification for classification or non-classification
Therefore N-(1,1,3,3-tetramethylbutyl)acrylamide is only moderately acutely toxic by the oral route and is classified as category 4 under the EU CLP (GHS) criteria. The low dermal penetration indicates that acute dermal toxicity would not be expected to require classification. It is not justified to develop animal data for acute inhalation toxicity so it is not classified..
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.