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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-175-2 | CAS number: -
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- For two days the temperature was below the range stated in the protocol
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, C10-C14-tert-alkyl
- EC Number:
- 701-175-2
- Cas Number:
- 68955-53-3
- Molecular formula:
- C10H23N to C14H31N
- IUPAC Name:
- Amines, C10-C14-tert-alkyl
- Details on test material:
- Test Substance: primeneTM 81-R (Lot No.: 0050A400, TD No. 00-025)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chrales River-Kingston, Stone Ridge, New York
- Age at study initiation: 8 weeks (males); 10 weeks (females)
- Weight at study initiation: 234-274 g (males); 219-267 g (females)
- Fasting period before study: no data
- Housing: 1/cage in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI certified rodent chow 5002 (C)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22 degrees C
- Humidity (%): 38-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: October 31, 2000 To: November 21, 2000
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 240-L Plexiglas and stainless steel chamber
- Exposure chamber volume: 240-L
- Method of holding animals in test chamber: nose-only restraining tubes (15 cm length x 5 cm diameter PVC pipe). Each animal was restrained in the tube with a neoprene stopper in the rear and a plastic funnel in the front.
- Source and rate of air: conditioned laboratory air airflow rate approximately 100 to 118 L/min
- Method of conditioning air: not aplicable
- System of generating aerosols: An FMI G20 RHOCKC Micropump (Fluid Metering, Oyster Bay, NY) delivered the neat test material to the top of a glass 20 inch counter current vapor generator. The test material dripped onto a heat coil (set at 120 degrees F, 140 degrees F or 130 degrees F for the 91, 231 and 151 ppm exposures, respectively) contained inside the glass counter current vapor generator. As the test material vaporized, compressed air (11 psi) forced the vaporized test material up through a glass manifold (wrapped in heat tape which maintained a temperature of 43 to 61 degrees C). The glass manifold delivered the vaporized test material into the top of the exposure chamber. Vaproized test material was directed into the top of a 240-L Plexiglas and stainless steel chamber and mixed with the conditioned laboratory air drawn through a HEPA particle filter located on the chamber inlet. The exposure atmosphere was exhausted at the bottom of the exposure chamber and passed through a series of filters (coarse particulate, HEPA, charcoal filters and an aqueous scrubber) before being released at roof level of the building. Chamber airflow was monitored continuously by measuring the pressure drop across a critical orifice plate located in the chamber exhaust duct.
- Method of particle size determination: no data
- Treatment of exhaust air: exhausted at the bottom of the exposure chamber and passed through a series of filters (coarse particulate, HEPA, charcoal filters and an aqueous scrubber) before being released at roof level of the building.
- Temperature, humidity, pressure in air chamber: 24.6 to 25.7 degrees C, 33% humidity
TEST ATMOSPHERE
- Brief description of analytical method used: The test material vapor in the inhalation chamber was directly sampled using silicosteel tubing connected to a 6 port gas sampling valve on a Gas Chromatograph (GC). Two samples/hour were taken during each exposure period to insure adequate characterization of the atmosphere. The saturated vapor concentration of the test material was determined using the same sampling and analytical methodology used to measure the test material concentrations during the animal exposures. The saturated vapor concentration was measured at room temperature (19°C) and at a temperature similar to that measured in the test atmosphere during the inhalation exposures (24°C). The saturated vapor concentration of the test material at room
temperature was obtained by placing 20 ml of the test material into a Tedlar bag and equilibrating the bag overnight at room temperature. The saturated vapor concentration of the test material at 24°C was obtained by placing 20 ml of the test material into a Tedlar bag and placing the bag in an oven overnight. The Tedlar bags were directly sampled using silicosteel tubing connected to a 6 port gas sampling valve on a Gas Chromatograph (GC).
- Samples taken from breathing zone: yes
VEHICLE not applicable; no vehicle
TEST ATMOSPHERE (if not tabulated) Not applicable- vapor study
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
CLASS METHOD (if applicable) not applicable - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- GC
- Duration of exposure:
- 4 h
- Concentrations:
- 91, 151, 231 ppm
- No. of animals per sex per dose:
- 30
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for signs of intoxication during the exposure period and daily for 14 days following exposure. Body weights were recorded on days 0, 7, and 14 during the fourteen-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The female LC50, 95% confidence limits and slope were calculated from the logarithm of the doses and the incidences of mortality using a SAS PROBIT procedure (SAS Institute Inc. SAS User's Guide: Statistics, Version 6 Edition, p 1324 - 1350. Cary, NC: SAS Institute Inc., 1990) based on the method of D.J. Finney (Probit Analysis, Thrid Edition, London: Cambridge Universtiy Press, 1971)
Results and discussion
- Preliminary study:
- Not applicable
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 157 ppm
- 95% CL:
- > 90 - < 249
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 157 ppm
- 95% CL:
- > 90 - < 249
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 231 ppm
- Exp. duration:
- 4 h
- Mortality:
- - Time of death: Males - 2 at 231 ppm during exposure period (day 0). Females - 1 at 151 ppm during exposure period (day 0); 1 at 151 ppm on day 1; 3 at 231 ppm during exposure period (day 0); 1 at 231 ppm on day 1.
- Number of deaths at each dose: (number of deaths/number treated)
Dose (ppm) 91 151 231
Males 0/5 0/5 2/5
Females 0/5 2/5 4/5 - Clinical signs:
- other: Numerous clinical signs of toxicity were noted in all exposure levels in both sexes beginning upon removal from the chamber and continuing through day 7. These clinical signs included: respiratory noise, labored breathing, gasping, abnormal gait, ataxia,
- Body weight:
- There was no effect on body weight in either sex at any exposure level when compared to historical control values.
- Gross pathology:
- Necropsy of the decedents revealed dark, mottled and/or reddened lungs, distended stomachs, and thymus reddened and/or having multiple red foci. Necropsy of the survivors revealed no gross changes.
- Other findings:
- - Potential target organs: lungs
- Other observations: SEX-SPECIFIC DIFFERENCES: Even though the results did not indicate a statistically significant sex-related difference in mortality across dose groups for males and females, the LC50 was calculated on the female mortality incidences at each dose since at least 50% mortality was not observed in males at the highest exposure level (231 ppm).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Executive summary:
The acute inhalation toxicity of the test material was assessed in Crl:CD®BR rats. Three groups of five male and five female rats received a single 4-hr noseonly inhalation exposure to the test material vapor concentrations of 91, 151 and 231 ppm equivalent to 0.69, 1.14, and 1.75 mg test material/L of air. The saturated vapor concentration of the test material was determined using the same sampling and analytical methodology used to measure vapor concentration during the inhalation exposures. Measurements were made at approximately room temperature and at a temperature similar to that of the test atmosphere during the animal exposures. Exposure-related mortality occurred in animals exposed to the test material at 151 ppm and above. No deaths occurred in the 91 ppm group or in males at 151 ppm. The total mortality incidences (no. deaths/no. treated) for males and females in this study were:
Dose (ppm) 91 151 231
Males 0/5 0/5 2/5
Females 0/5 2/5 4/5
The LC50 value was calculated from the female mortality incidence data. Numerous clinical signs of toxicity were noted in all exposure levels in both sexes beginning upon removal from the chamber and continuing through day 7. These clinical signs included: respiratory noise, labored breathing, gasping, abnormal gait, ataxia, tremors, passiveness, scant feces, arched back, prostration and/or yellow/brown stained anogenital area. There was no effect on body weight among survivors in either sex at any exposure level. Necropsy of the decedents revealed dark, mottled and/or reddened lungs, distended stomachs, and thymus reddened and/or having multiple red foci. Necropsy of the survivors revealed no gross changes. The acute inhalation LC50 for the test material in female rats was 157 ppm (1.19 mg/L) with 95% confidence limits of 90 to 249 ppm. The acute inhalation LC50 for the test material in male rats was greater than 231 ppm (1.75 mg/L). The saturated vapor concentration of the test material was 150 ppm at 19°C (room temperature) and 220 ppm at 24°C (similar to temperature of test atmospheres).
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.