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EC number: 605-539-0 | CAS number: 169115-74-6
- 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 acute oral LD50 of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is considered to be > 2000 mg/kg bw, based on studies with the immediate cleavage product 1-amino-2-propanol.
The acute dermal LD50 of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is considered to be > 2000 mg/kg bw, based on studies with the substance in ethylene glycol.
No reliable data are available for acute inhalation toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: group entry
- Principles of method if other than guideline:
- old methods for acute oral toxicity testing
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Route of administration:
- oral: unspecified
- Dose descriptor:
- LD50
- Effect level:
- 1 715 mg/kg bw
- Remarks on result:
- other: reduced body temperature, diarrhoea, drowsiness
- Dose descriptor:
- LD50
- Effect level:
- 4 260 mg/kg bw
- Dose descriptor:
- LD50
- Effect level:
- 2 813 mg/kg bw
- Remarks on result:
- other: aqueous solutions of 2, 20, and 30% were administered; clinical symptoms: agitation, staggering gait, dispnoea, convulsions; macroscopic signs: none
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 098 mg/kg bw
- Remarks on result:
- other: groups of 6 rats were given 500 to 3500 mg/kg bw of the test substance; all rats were lethargic and had diarrhea and rough hair coats; no treatment related effects were observed upon pathological examination at the end of the 2 week observation period.
- Executive summary:
Various early acute oral toxicity studies not performed under GLP in summary show an LD50 of > 2000 mg/kg bw for 1-amino-2-propanol in rats. Clinical signs were reported as e.g. diarrhea, rough hair coats and lethargic behaviour.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: RCCHan:WIST
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 9-13 weeks
- Diet and water: ad libitum
- Acclimation period: at least 5 days - Type of coverage:
- other: semiocclusive, but predominantly covered with air-tight plaster
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TREATMENT
The liquid test substance was applied pure.
Treatment area: 30 cm²
TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn (approximately 10% of the body surface area). For each dose and animal the required amount of the pure liquid test substance was calculated on the base of the body weight at time of dosing. This amount was weighed and applied as uniformly and thinly as possible to the test area, covered with a gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with air-tight "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.
REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. - Duration of exposure:
- 24 hours
- Doses:
- limit dose of 2000 mg/kg bw ; according to 18.8 to 20 mg/cm² for male rats and 15.8 to 16.8 mg/cm² for female rats.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at least 14 days
- Frequency of observations: once daily
- Frequency of weight determination: once weekly
- Necropsy of survivors performed: yes - Statistics:
- none; limit dose test
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortalities, clinical signs, toxicological effects on weight development and gross pathological findings
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: none
- Gross pathology:
- The necropsies performed at the end of the study revealed no particular findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Executive summary:
Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was tested in an acute dermal toxicity study on rats performed according to OECD TG 402. For the purpose of a limit test 2000 mg/kg bw of the test item were applied to the skin of 5 male and 5 female rats for 24 hours. The test substance was tolerated by the animals without mortalities, clinical signs, toxicological effects on weight development and gross pathological findings. The resulting LD50 was determined with > 2000 mg/kg bw for both sexes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
A detailed justification for read-across and classification is attached to IUCLID chapter 13 (Tegethoff, 2013b).
It was shown in a hydrolysis study performed according to OECD TG 111 that carbamic acid, (2-hydroxypropyl) -, compound with 1-amino-2-propanol (1:1) is extremely unstable in acidic aqueous media and completely disintegrates into1-amino-2-propanolunder formation of CO2within less than 5 minutes (see IUCLID section 5.1.2). Such a rapid disintegration can also be expected in the acidic environment of the stomach of laboratory animals after oral administration and of the stomach of humans in the unlikely case of accidentally oral ingestion. Thus, according to Annex VIII and XI, column 2 of REACH Regulation (EC) 1907/2006 repeated dose toxicity studies do not need to be conducted if a substance undergoes immediate disintegration and there are sufficient data on the cleavage products. The immediate cleavage product of carbamic acid, (2-hydroxypropyl) -, compound with 1-amino-2-propanol (1:1) after oral uptake is1-amino-2-propanolunder formation ofcarbon dioxide. With regard to human health effects CO2can be considered as of minor importance (see section 7.0 of IUCLID data set). The major and relevant cleavage product1-amino-2-propanolis toxicologically well investigated, shows a comprehensive toxicological data base (see sections 7.2 to 7.8 of IUCLID data set) and has been assessed in authority based peer review processes, either for establishment of an occupational exposure level (www. baua. de) or in the ICCA/HPV progamme. Therefore, in line with Annex XI of Regulation (EC) No 1907/2006 and taking into account animal welfare considerations, no studies with oral application were performed for the product itself but read across via1-amino-2-propanolwas chosen for the registration of carbamic acid, (2-hydroxypropyl) -, compound with 1-amino-2-propanol (1:1) for all endpoints with potential oral administration (acute oral toxicity, repeated dose toxicity and reproductive toxicity). All other relevant toxicological studies have been performed with the stabilized trade product carbamic acid, (2-hydroxypropyl) -, compound with 1-amino-2-propanol (1:1) in ethylene glycol itself.
Oral route
As described above it was shown that under acidic environmental conditions carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) immediately disintegrates into1-amino-2-propanol and carbon dioxide. Such a rapid disintegration can be expected also in the acidic environment of the stomach of laboratory animals after oral administration and of the stomach of humans in the unlikely case of accidentally oral ingestion. Thus, for evaluation of the acute oral toxicity of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) read-across of data for 1-amino-2-propanol was considered appropriate.
Various early acute oral toxicity studies not performed under GLP in summary show an LD50 of > 2000 mg/kg bw for 1-amino-2-propanol in rats (Burkatskaya, 1986; Smyth, 1951; Oettel and Zeller, 1965). Thus, the acute oral toxicity of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is also considered with an LD50 of > 2000 mg/kg bw.
Inhalation route
Acute inhalation toxicity studies are not available for carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1).
Dermal route
Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was tested in an acute dermal toxicity study on rats performed according to OECD TG 402 (Gillissen, 2012). For the purpose of a limit test 2000 mg/kg bw of the test item were applied to the skin of 5 male and 5 female rats for 24 hours. The test substance was tolerated by the animals without mortalities, clinical signs, toxicological effects on weight development and gross pathological findings. The resulting LD50 was determined with > 2000 mg/kg bw for both sexes.
Justification for selection of acute toxicity – oral endpoint
group entry
Justification for selection of acute toxicity – dermal endpoint
only one study available
Justification for classification or non-classification
A detailed justification for read-across and classification is attached to IUCLID chapter 13 (Tegethoff, 2013b).
No classification is required for acute oral and dermal toxicity based on the study results with the substance (dermal) and via read-across of the immediate cleavage product (oral). No data are available for acute inhalation toxicity.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.