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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 229-227-5 | CAS number: 6441-82-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Sub-chronic study for 1,2 dichloropropane in rats by oral gavage.
- Author:
- U.S. National Library of Medicine
- Year:
- 2 017
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC, 2017.
- Reference Type:
- secondary source
- Title:
- Sub-chronic study for 1,2 dichloropropane in rats by oral gavage.
- Author:
- OECD SIDS,SIAM17
- Year:
- 2 003
- Bibliographic source:
- Sub-chronic study for 1,2 dichloropropane in rats by oral gavage, OECD SIDS,SIAM17, 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the toxic nature of 1,2 dichloropropane in male and female Fischer 344 rats by oral gavage for 13 weeks.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-dichloropropane
- EC Number:
- 201-152-2
- EC Name:
- 1,2-dichloropropane
- Cas Number:
- 78-87-5
- Molecular formula:
- C3H6Cl2
- IUPAC Name:
- 1,2-dichloropropane
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1,2 dichloropropane
- Molecular formula ;C3H6Cl2
- Molecular weight ;112.986
--Purity;99.9%
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Age at study initiation: 7-8 wk
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 60, 125, 250, 500 or 1000
mg/kg bw/day
- Amount of vehicle (if gavage):
- Lot/batch - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of test article in the dosing solutions was verified using GC-FID. GC analysis of the dosing solutions demonstrated that the achieved concentration was 95 - 100% of target.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/wk for 13 wk
Doses / concentrations
- Remarks:
- 0, 60, 125, 250, 500 or 1000 mg/kg bw/day
- No. of animals per sex per dose:
- Total no. of animals 120
0 mg/kg bw/day -10 male and 10 female animals
60 mg/kg bw/day -10 male and 10 female animals
125 mg/kg bw/day -10 male and 10 female animals
250 mg/kg bw/day -10 male and 10 female animals
500 mg/kg bw/day -10 male and 10 female animals
1000 mg/kg bw/day -10 male and 10 female animals - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily. Each animal was given a detailed weekly examination, including palpation for tissue masses or swelling
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes , Necropsies were performed on all surviving animals at the end of the treatment period.
HISTOPATHOLOGY: Yes , A comprehensive range of tissues were sampled and preserved, and those from the controls, 500 mg/kg and 1000 mg/kg groups
subject to Microscopic examination. - Statistics:
- Mean ± Standard deviation was observed.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All male and female rats given 1000 mg/kg bw/day and 5/10 males from the 500 mg/kg bw group died before necropsy. All animals from the other treatment groups survived until study termination
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Final mean body weights were decreased 16% in male and 8% in females given 500 mg/kg bw/d of treated group compare to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The liver was the only organ to be affected by treatment, with centrilobular congestion present in 5/10 males and 2/10 females given 1000 mg/kg bw/day of treated group compare to control.
Hepatic fatty change and centrilobular necrosis were observed in 2/10 females from the 1000 mg/kg bw/day of treated group compare to control. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 250 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No statistically significant effects were observed in clinical sign, body weight, gross pathology and histopathology
- Remarks on result:
- other: No toxic effect observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 250mg/kg/day in male and female Fischer 344 rats by oral gavage for 13 weeks for 1,2 dichloropropane(978-87-5).
- Executive summary:
2 dichloropropane was assessed for its possible toxic effect .For this purpose subchronic study was conducted in male and female Fischer 344 rats by oral gavage for 13 weeks. The test substance was exposed to the animals at the dose concentration of0, 60, 125, 250, 500 or 1000 mg/kg bw/day by using corn oil as vehicle. The animals were observed for Mortality, clinical sign, Body weight, gross pathology and Histopathology.All male and female rats given 1000 mg/kg bw/day and 5/10 males from the 500 mg/kg bw group died before necropsy. All animals from the other treatment groups survived until study termination.No statistically significant effects were observed.All male and female rats given 1000 mg/kg bw/day and 5/10 males from the 500 mg/kg bw/day group died before necropsy. All animals from the other treatment groups survived until study termination. Significant effect were observed at the body weight and the histopatholgy of the liver at the dose group of 500 mg/kg/day of trated group compare to control. No significant effectwere observed at 250 mg/kg bw/day . Therefore NOAEL was considered to be 250 mg/kg bw/day for2 dichloropropane in male and female Fischer 344 rats by oral gavage for 13 weeks.Significant effect were observed at the body weight and the histopatholgy of the liver at the dose group of 500 mg/kg/day of trated group compare to control. No significant effectwere observed at 250 mg/kg bw/day . Therefore NOAEL was considered to be 250 mg/kg bw/day for2 dichloropropane in male and female Fischer 344 rats by oral gavage for 13 weeks.
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.