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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- 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
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: Charles River Kingston, Stone Ridge, New York
- Age at study initiation: 55 days (males); 65 days (females)
- Weight at study initiation: 184-232 g (males); 187-217 g (females)
- Fasting period before study: overnight
- Housing: 1/cage in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina certified rodent chow 5002 (C)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 74-74 degrees F (23-24 degrees C)
- Humidity (%): 41-46%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark
IN-LIFE DATES: From: July 21, 1992 To: August 6, 1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: corn oil dispersion
- Amount of vehicle (if gavage): corn oil dispersion 10 mL/kg
- Justification for choice of vehicle: corn oil is a standard vehicle
- Lot/batch no. (if required): 80H0835
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION (if unusual): dispersed in corn oil using a magnetic stirring bar
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: N/A - Doses:
- 50, 250, 500, 750, 1000, 1500 mg/kg
- No. of animals per sex per dose:
- 60
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: 0.5, 1, 2, and 4 hr after dosing and once daily for 14 days; Body weights were recorded Day 0 prior to dosing and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LD50 95% confidence limits were calculated from the logarithm of the doses and the incidence of maortality using the Thompson moving average procedure (W.R. Thompson, "Use of Moving Averages and Interpolation to Estimate Median-Effective Dose", Bacteriol. Rev. 11, pp. 115-145, 1947). Slope estimates were obtained using the methods outlined by Weil (C.S. Weil, "Economical LD50 and Slope Determinations", Drug and Chemical Toxicology 6(6), pp. 595-603, 1983). All calculations were performed using the Statistical Analysis System on an IBM mainframe computer (SAS Institute Inc. SAS User's Guide: Basics, Version 5 Edition, Cary, NC:SAS Institute Inc., 1985)
Results and discussion
- Preliminary study:
- Not applicable
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 612 mg/kg bw
- 95% CL:
- 442 - 848
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 177 mg/kg bw
- 95% CL:
- 974 - 1 422
- Mortality:
- - Time of death: Males - 2 at 1000 mg/kg on day 1; 1 at 1500 mg/kg 1 hr post-dosing (day 0); 3 at 1500 mg/kg on day 1; 1 at 1500 mg/kg on day 2. Females - 2 at 500 mg/kg 2 hr post-dosing (day 0); 1 at 500 mg/kg 4 hr post-dosing (day 0); 1 at 500 mg/kg on day 1; 1 at 750 mg/kg 1 hr post-dosing (day 0); 1 at 750 mg/kg 2 hr post-dosing (day 0); 5 at 1500 mg/kg 1 hr post-dosing (day 0); 1 at 1500 mg/kg 2 hr post-dosing (day 0).
- Number of deaths at each dose: (number of deaths/number treated)
Dose (mg/kg) 50 250 500 750 1000 1500
Males --- 0/6 0/6 0/6 2/6 5/6
Females 0/6 0/6 4/6 2/6 --- 6/6 - Clinical signs:
- other: No clinical signs related to test substance were observed in the 250-mg/kg group for males and in the 50- and 250-mg/kg groups for the females. Clinical signs indicative of neurotoxicity (abnormal gait, tremors, and convulsions) were observed at dose leve
- Gross pathology:
- Necropsy of the decedents revealed numerous gastro-intestinal effects related to the test substance. Necropsy of the survivors revealed no gross changes related to the test substance.
- Other findings:
- - Potential target organs: gastro-intestinal tract
- Other observations: Statistically significant sex-related difference in mortality observed.
Any other information on results incl. tables
Since there was a statistically significant sex-related difference in mortality observed, the LD50 was calculated separately for males and females.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 in female rats is 612 mg/kg.
- Executive summary:
The acute oral toxicity of the test material was assessed in Crl:CD BR rats. The test material was dispersed in corn oil and gavaged to five groups of male rats (6/group) at 250, 500, 750, 1000 or 1500 mg/kg and five groups of female rats (6/group) at 50, 250, 500, 750 and 1500 mg/kg. The corn oil dispersions were dosed at a constant volume of 10 ml/kg body weight. Mortality was observed in the 1000 and 1500 mg/kg dose groups in males and in the 500, 750 and 1500 mg/kg dose groups in females. No clinical signs related to test substance were observed in the 250 mg/kg group for males and in the 50 and 250 mg/kg groups in females. Clinical signs at dose levels of 500 mg/kg and greater in survivors as well as decedents. Surviving animals recovered from the neurotoxic effects by day 2 of the study. Other clincial signs related to the test substance observed in survivors as well as decedents included prostration, abnormal breathing patterns, scant or no feces and ptosis. There were no apparent dose-related body weight effects in this study. Necropsy of the decedents revealed numerous gastro-intestinal effects related to the test substanced. Necropsy of the survivors revealed no gross changes related to the test substance. the no observed effect level (NOEL) was 250 mg/kg.
Since there was a statistically significant sex-related difference in mortality observed, the LD50 in males rats was 1177 mg/kg with 95% confidence limits of 974 and 1422 mg/kg. The acute oral LD50 in female rats was 612 mg/kg with 95% confidence limits oof 442 and 848 mg/kg.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)