Registration Dossier
Registration Dossier
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: 213-156-1 | CAS number: 927-62-8
- 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
The substance is highly corrosive to the skin. Deaths occurred following oral and inhalation exposure. Local effects but no systemic effects or deaths were seen following dermal exposure up to 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 184 mg/kg bw
- Quality of whole database:
- Good and suitable for assessment.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- Low but suitable for assessment. 2 mg/L < LC50 < 200 mg/L
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Suitable for assessment.
Additional information
The pH-value of N,N-dimethylbutylamine is considered to be >11.5 (see also section 4.20 of this dossier). According to OECD 404 (adopted 2002) the test substance is therefore considered to be corrosive to the intact skin and classification is proposed accordingly. In accordance with EC/1907/2006, No. 8.5 column 2, testing of substances that are corrosive to the skin for the acute toxicity endpoints is not needed. However, valid studies exist and can be taken into consideration whereas new studies are not required.
The substance was highly corrosive to the skin in-vivo and produced irreversible skin lesions within 3 minutes, i.e. the consideration based on the pKa value was correct. Outlines of the most valid available acute toxicity studies are given below. It should be noted that only the free base is corrosive, whereas the salt is generally not corrosive and consequently much less toxic. The studies below were all conducted with the free base.
Acute oral toxicity
The acute oral toxicity of N,N-dimethylbutylamine (160, 200, 250, 315 mg/kg bw; suspended in sesame oil) was examined in a guideline study (OECD 401) under GLP conditions. Young Wistar rats (5 per dose and sex) were treated and reactions were observed during the 14-day observation period.
Deaths occurred within 2 hours after dosing. The LD50 was 258 mg/kg bw in males and 184 mg/kg bw in females. A combined LD50 value could not be calculated.Signs of corrosion were seen in the gastro-intestinal tract of victims but not in animals that were sacrificed at the end of the observation period (Markert and Weigand, 1985)
Deviations from the test guideline include the use of a vehicle (sesame oil) instead of water. The dose volume varied largely across groups (0.8 to 3.2 mL/kg bw) and exceeded the recommended volume (1.0 mL/kg bw; OECD 401) in the low dose groups. The study is, however, considered to be valid and suitable for assessment, taking the lower LD50 value (184 mg/kg bw) for both male and female rats into consideration.
Acute inhalation toxicity
The acute inhalation toxicity was determined in CD1 rats (5 per sex and dose) in a pre-guideline study without monitoring of the test substance concentration. All rats exposed at 2 mg/L survived until the end of the observation period while all rats exposed to nominal 200 mg/L died within 10 minutes after exposure initiation. Clinical signs indicated irritating effects both in the low dose and the high dose group (ocular and nasal discharge, corneal opacity in surviving animals; lung congestion and lung edema in victims). Thus the (LC50(4 hrs) was between 2 mg/L and 200 mg/l in this study (Wazeter and Goldenthal, 1975).
The study does not allow estimating the LC50-value. However, the described signs of toxicity clearly indicate that the primary mode of action is the irritating and corrosive effect of Dimethylbutylamine. The study is therefore considered to be supportive for assessment.
Acute dermal toxicity
The acute dermal toxicity of N,N-dimethylbutylamine (2000 mg/kg bw; free base) was examined in a rat study (5 male and female Sprague Dawley rats) that was conducted according to OECD 402 and under GLP conditions. There were no deaths or clinical signs of toxicity including body weight in any of the rats within the 14-day observation period. Local skin effects were not reported but must be assumed because of the corrosivity of the free base. Thus the dermal LD50 in the rat was >2000 mg/kg bw in this study (Hewitt and Collier,1985). This study is considered to be valid and suitable for assessment.
Justification for selection of acute toxicity – oral endpoint
GLP guideline study: Lowest LD50 value
Justification for selection of acute toxicity – inhalation endpoint
The substance is corrosive to the skin. Results from a screening inhalation study are also available though a LD50-value was not derived.
Justification for selection of acute toxicity – dermal endpoint
The substance is corrosive to the skin. Local effects but no systemic effects were seen up to 2000 mg/kg bw.
Justification for classification or non-classification
Acute toxicity classification according to EC/1272/2008 and 2nd ATP (EC/286/2011 dated 2011 -03 -10) table 3.1.1 is proposed as follows, based on the effect levels described above.
Endpoint |
Effect level |
Category according to EC/286/2011, Table 3.1.1. |
Acute oral toxicity |
LD50: 184 mg/kg bw |
3 |
Acute inhalation toxicity |
LC50: 2 mg/L < LC50 < 200 mg/L |
3 (vapour) EU071: corrosion to the respiratory tract |
Acute dermal toxicity |
LD50 > 2000 mg/kg bw |
No classification |
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.
