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EC number: 203-457-6 | CAS number: 107-05-1
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: - scientifically sound study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- male mice were sacrificed 5 wks after the last of 5 consecutive inhalative treatments and sperm was extracted from the cauda epididymes fixed, stained and microscopically analyzed for abnormalities
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 3-chloropropene
- EC Number:
- 203-457-6
- EC Name:
- 3-chloropropene
- Cas Number:
- 107-05-1
- Molecular formula:
- C3H5Cl
- IUPAC Name:
- 3-chloroprop-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 3-chloropropene
- Physical state: clear, colourless liquid
- Analytical purity: 98 %
- Impurities (identity and concentrations): not reported
- Purity test date: not reported
- Lot/batch No.: Batch No. 17835
- Supplier: Aldrich Chemical Company Limited (18 March 1980)
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported, but expected to be stable
- Storage condition of test material: retained in the dark under ambient conditions in the company dispensary until used
- Other:
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U.S.A.)
- Age at study initiation: 10 - 12 wks
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): Spratts-Spillers No. 1
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 26, average 22
- Humidity (%): 30 - 68, average 50
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: chambers constructed of glass and steel, 1.5 m³ inner size
- Method of holding animals in test chamber: caged individually
- Source and rate of air: 12 airchanges/h, Compressed air was supplied py means of 2 Broomwade compressors (Type CAR31) fitted with automatic pressure control switches. These supplied filtered, conditioned, oil-free compressed air for subsequent dilution of test atmospheres.
- Method of conditioning air: see above
- Temperature, humidity, pressure in air chamber: not reported
- System of generating particulates/aerosols: The high level atmosphere was produced by bubbling dry, oxygen-free nitrogen (BOC Limited) through a liquid reservoir of 3-chloropropene contained in a glass, gas washing or Drechel bottle immersed in a temperature controlled water bath at 1 °C. The low level atmosphere was generated by inserting a 100 µL glass syringe, through a rubber septum, into a glass T piece and feeding a constant volume of 3-chloropropene into a stream of nitrogen gas. The micro syringe was activated by a syringe driver. The nitrogen/3-chloropropene vapour mixture so generated was ducted through 7/16" ID stainless steel piping to a glass mixing vessel and diluted with filtered, compressed air. The resulting mixture of 3-chloropropene/air was ducted through 7/8" stainless steel piping to the top of the exposure chamber. The required atmospheric concentrations within the exposure chambers were maintained by finely regulating the flow of nitrogen and diluting air into the mixing vessels, by means of adjustable flow meters.
- Air flow rate: not reported in detail,
- Air change rate: 12 airchanges/h were maintained
- Treatment of exhaust air: Test atmospheres were exhausted from the exposure chambers using a Gast extract pump. Contaminated air extracted from
the exposure chamber was 'scrubbed' using methylated spirits/water treatment. It was then diluted in the building exhaust air before discharging to the external atmosphere. The exposure chambers were maintained under slight negative pressure (variable, but normally 2-3 cm water) to minimise any possible leakage of test material into the working environment.
TEST ATMOSPHERE
- Brief description of analytical method used: The atmospheres within the exposure chambers were analysed by infra-red spectroscopy using Miran-1A Portable Gas Analysers (Foxboro/Wilks Inc).
- Samples taken from breathing zone: yes
VEHICLE (if applicable)
- no vehicle used - Details on mating procedure:
- not applicable, no mating occured, only sperm was analyzed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The atmospheres within the exposure chambers were analysed by infra-red spectroscopy using Miran-1A Portable Gas Analysers (Foxboro/Wilks Inc). This type of instrument is a single beam, variable wavelength spectrometer, scanning the infra-red spectrum between 2.5 and 14.5 µm. It is equipped with a gas cell having a variable pathlength of between 0.75 and 21.75 m. Samples of the chamber air were continuously pumped (5 l/min) through stainless steel sample lines of 3/8'' ID, to the gas cell of the analyser. The concentration was measured and relayed to a chart recorder (Servoscribe RE 541) to provide a permanent record of the chamber concentrations.
The infra-red gas analyser used to monitor chamber atmospheres of 3-chloropropene were calibrated each day before vapour generation commenced using a closed loop calibration system. - Duration of treatment / exposure:
- 7 h
- Frequency of treatment:
- on five consecutive days
- Details on study schedule:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 and 25 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: not reported
- Rationale for animal assignment (if not random): Empty cages were placed on racks and, upon receipt of the animals, starting with the male rats, a transporting box was opened and a rat placed in the first cage. A second rat was removed from the same transport box and placed in the second c8ge and so on until all the cages designated for the male rats each contained one animal. - Positive control:
- yes, 200 mg/Kg ethyl methanesulphonate was administered orally by gavage to the rodents at a constant dose volume of 10 mL/kg at on 5 consecutive days.
Examinations
- Parental animals: Observations and examinations:
- not applicable
- Oestrous cyclicity (parental animals):
- not applicable
- Sperm parameters (parental animals):
- Parameters examined in males:
sperm morphology:
The following types of sperm were not scored:
(1) separated tails and heads.
(2) clumps of sperm.
(3) sperm orientated so that the hook could not be
seen.
(4) sperm partially masked by any remaining stain
droplets.
Otherwise, sperm were scored and placed in one of the
following categories:
I Normal
II Abnormal
A. hook upturned or elongated.
B. banana-shaped head.
c. amorphous hoad.
D. abnormal tail (sharp, 1800 angle or tight
coiling only).
E. miscellaneous tthese were specified in footnotes, could include multiple tails, double heads, twisted neck, filamentous midplece, enlarged mid-piece, plier type). - Litter observations:
- not applicable
- Postmortem examinations (parental animals):
- not applicable
- Postmortem examinations (offspring):
- not applicable
- Statistics:
- The data were transformed using the Freeman-Tukey transformation for proportions. A one-sided t test was used on the transformed values. This analysis was performed on (a) total abnormal cells and (b) each of the abnormal categories A-E.
- Reproductive indices:
- not applicable
- Offspring viability indices:
- not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not examined
Details on results (P0)
There were small increases in aberrant sperm frequencies in Categories C and D (amorphous head and folded tail, respectively) with the positive control substance indicating the suitability of the test system.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 25 ppm
- Sex:
- male
- Basis for effect level:
- other: no effects were seen at this level
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- NOEL
- Effect level:
- 25 ppm
- Sex:
- male
- Basis for effect level:
- other: no effects were seen at this level
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
- table 1: abnormality scoring
Dose Group |
Number |
Number Abnormal |
Percent Abnormal |
||||||||||
A |
B |
C |
D |
E |
Total |
A |
B |
C |
D |
E |
Total i |
||
Air Control, 7 h/day |
9590 |
10 |
15 |
183 |
51 |
151 |
410 |
0.10 |
0.15 |
1.83 |
0.51 |
1.51 |
4.10 |
1 ppm, 7 h/day |
9626 |
11 |
19 |
132 |
77 |
135 |
374 |
0.11 |
0.19 |
1.32 |
0.77 |
1.35 |
3.74 |
25 ppm, 7 h/day |
9636 |
6 |
18 |
148 |
52 |
140 |
364 |
0.06 |
0.15 |
1.48 |
0.52 |
1.40 |
3.64 |
EMS, 200 mg/kg/day |
9495 |
16 |
20 |
1228 |
110 |
131 |
505 |
0.16 |
0.20 |
2.28 |
1.10 |
1.13 |
5.05 |
A: hook upturned or elongated.
B: banana-shaped head.
C: amorphous hoad.
D: abnormal tail (sharp, 1800 angle or tight coiling only).
E: miscellaneous tthese were specified in footnotes, could include multiple tails, double heads, twisted neck, filamentous midplece, enlarged mid-piece, plier type).
EMS: ethyl methanesulphonate
Applicant's summary and conclusion
- Conclusions:
- A sperm abnormality test was conducted with 3-chloropropene in male mice 5 wks after the last of 5 consecutive inhalative treatments.
No adverse effects were seen with both exposure concentrations. - Executive summary:
In the present study a sperm abnormality test was conducted with 3-chloropropene in male mice 5 wks after the last of 5 consecutive inhalative treatments (7 h; 1, 25 ppm). No adverse effects were seen with both exposure concentrations. As the exposure concentrations are very low even for a subacute exposure no clear conclusion can be drawn on the genotoxicity in vivo.
Mice were killed 5 weeks from the last day of dosing by neck dislocation, sperm was extracted from the cauda epididymes and smears were analyzed microscopically for abnormalities.
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