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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-439-8 | CAS number: 106-89-8
- 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
Using the GHS classification system, epichlorohydrin is a Category 3 following oral, dermal and inhalation exposure.
KJB 05/10/2018. The acute inhalation classification was corrected from category 2 to category 3 in 7.2.2 in Applicants summary and conclusion section.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP, study was conducted in accordance with Guidelines and sufficient data is available for the interpretation of results.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- Not specified in report
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Fischer 344 and Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Fischer 344 rats: Charles River Breeding Laboratories, Portage, MI; Sprague-Dawley rats: Spartan Research Animals, Inc., Haslett, MI
Age: 7-8 weeks
Mean Weight at Study Initiation: male Fischer 344 rats: 103-185 g female Fischer 344 rats: 80-132 g; male Sprague-Dawley rats: 262-325 g; female Sprague-Dawley rats: 192-208 g - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Doses per time period: Single-dose oral gavage
Maximum volume administered: Fischer 344 rats: 2.8 ml; Sprague-Dawley rats: 4.7 ml
Post-Dose Observation Period: 2 weeks - Doses:
- 25, 50, 100, 200, 210, 225, 252, 398, 795 mg/kg for male and female Fischer 344 rats
24, 50, 100, 200, 398 and 795 mg/kg for male and female Sprague-Dawley rats. - No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- Examinations: Clinical observations, gross pathological examination
- Statistics:
- Statistics: The acute oral median lethal dose and approximate slope of the dose-response curve for both strains were calculated by the moving average method of Thompson and Weil (Biometrics 8: 51-54, 1952).
- Preliminary study:
- not applicable
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 282 mg/kg bw
- 95% CL:
- 117 - 448
- Remarks on result:
- other: Sprague-Dawley rat calculated using moving average method
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 175 mg/kg bw
- 95% CL:
- 116 - 306
- Remarks on result:
- other: Sprague-Dawley rat calculated using moving average method
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 218 mg/kg bw
- Remarks on result:
- other: Fischer 344 rat calculated using moving average method
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 210 mg/kg bw
- 95% CL:
- 203 - 216
- Remarks on result:
- other: Fischer 344 rat calculated using moving average method
- Mortality:
- MORTALITY:
# Dead/# Treated
Dose Male Female Male Female
(mg/kg) S-D S-D CDF CDF
25 0/5 0/5 0/5 0/5
50 0/5 0/5 0/5 0/5
100 0/5 0/5 0/5 0/5
200 1/5 2/5 0/5 0/5
210 --- --- 0/5 3/5
225 --- --- 5/5 5/5
252 --- --- 5/5 5/5
398 4/5 5/5 5/5 5/5
795 5/5 5/5 5/5 5/5
---: not tested
Time to death not available. - Clinical signs:
- other: CLINICAL SIGNS: # Affected/# Treated Dose Sign Male Female Male Female (mg/kg) S-D S-D CDF CDF 25 0/5 0/5 0/5 0/5 50 0/5 0/5 0/5 0/5 100 0/5
- Gross pathology:
- GROSS PATHOLOGY:
Roughening and thickening of the squamous epithelium of the non-glandular stomach was observed in rats given 100-210 mg/kg with Sprague-Dawley rats exhibiting an increased incidence compared to Fischer 344 rats. Other findings were non-specific and not considered treatment-related. - Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: No significant differences observed. - Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 was calculated in male and female Sprague-Dawley and Fischer 344 rats. The LD50 ranged from 175-282 mg/kg.
- Executive summary:
The LD50 was calculated in male and female Sprague-Dawley and Fischer 344 rats for a number of compounds. The LD50 for epichlorohydrin ranged from 175-282 mg/kg.
Reference
The LD50 results were very similar between both strains and sexes with individual values ranging from 175 -282 mg/kg..
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 175 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with GLP guideline(DOT) and sufficient data is available for the interpretation of study results.
- Qualifier:
- according to guideline
- Guideline:
- other: DOT guidelines
- Deviations:
- no
- Principles of method if other than guideline:
- The 1 hour LC50 was determined for Epichlorohydrin in male and female rats
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Breeding Laboratories, Kingston, NY
Age: 6-8 weeks
Weight at study initiation: males: 177-266 g; females: 126-148 g
Number of animals: 6/sex/exposure concentration - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- ADMINISTRATION:
Type of Exposure: whole-body vapor exposures
Concentrations:
Target 500 1000 2000 2800 3350 4000
Nominal 599 1133 2329 3306 3866 4609
Analyt. 552 1008 1970 2865 3275 3995
Males only were exposed to analytical concentrations of 2865 and 3275 ppm.
Exposur es occurred in 2.6 cubic meter Rochester-type inhalation chambers. Atmospheres were generated by passing heated compressed air through a J-tube assembly as the test material entered the J-tube assembly. Chamber airflow was maintained at 400-500 liters/hour. Chamber concentrations were monitored 7 times/hour using gas chromatography. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gas chromatography
- Duration of exposure:
- 1 h
- Concentrations:
- Target 500 1000 2000 2800 3350 4000
Nominal 599 1133 2329 3306 3866 4609
Analyt. 552 1008 1970 2865 3275 3995
Males only were exposed to analytical concentrations of 2865 and 3275 ppm. - No. of animals per sex per dose:
- 6/sex/exposure concentration
- Control animals:
- no
- Details on study design:
- Animals were observed for signs of toxicity during exposure and for 14 days post-exposure. Animals were weighed at study initiation, and surviving rats were weighed on study days 2, 4, 8, 11, and 15. All animals were submitted for pathological examination of major organ systems either at death or at study termination. In addition, nasal cavities were split longitudinally for examination of the turbinate area.
- Statistics:
- The LC50 for females was calculated as a function of the time-weighted average analytical exposure concentrations by the moving-average method (Thompson and Weil, 1952). The LC50 for males was estimated by calculating the geometric man between exposure levels that resulted in 0 and 100% mortality among males, as implemented in a computer program furnished by Dr. Charles E. Stephan, USEPA Environmental Research Laboratory, Duluth, MN.
Based on the mortality observed in this study, a LC50 value for male
rats could not be calculated using the moving average method because there were no partial kills (Thompson and Weil, 1952). As an alternative, the LC50 for males was estimated by calculating the geometric mean between exposure levels that resulted in 0 and 100% mortality among male rats (i.e., 3275 and 3995 ppm, respectively), as implemented in a computer program furnished by Dr. Charles E. Stephan, USEPA Environmental Research Laboratory, Duluth, MN. - Preliminary study:
- not applicable
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 3 617 ppm
- Exp. duration:
- 1 h
- Remarks on result:
- other: no mortality observed at 3275 ppm and all rats died at 3995 ppm
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 2 165 ppm
- Exp. duration:
- 1 h
- Mortality:
- MORTALITY:
# Dead/# Treated Time to Death
Dose Male Female Male Female
(PPM) CDF CDF CDF CDF
552 0/6 0/6 --- ---
1008 0/6 0/6 --- ---
1970 0/6 2/6 --- 1@2 days
1@3 days
2865 0/6 --- --- ---
3275 0/6 --- --- ---
3995 6/6 6/6 3@1 day 6@1 day
1@2 days
1@3 days
1@4 days
---: not tested - Clinical signs:
- other: Signs of toxicity were predominantly noted at exposure concentrations of 1970 ppm and above, although all rats exposed to 1008 or 552 ppm spent most of their exposure time huddled in their cages with eyes completely shut. Signs of eye and nasal irritation
- Body weight:
- Body weights were essentially unaffected following exposure to 552 ppm with animals gaining weight. At higher concentrations, rats lost weight immediately following exposure but survivors gained weight thereafter.
- Gross pathology:
- The most frequent observation noted at necropsy among male rats surviving the 2-week observation period was bilaterial corneal cloudiness at 1970 ppm (1/6), 2865 (5/6), or 3275 (6/6). No other observations noted were considered to be treatment-related.
- Other findings:
- POTENTIAL TARGET ORGANS: Eye.
SEX-SPECIFIC DIFFERENCES: None other than differing LC50's - Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Based on the results of the study the 1 hour LC50 values of ECH in male and female Fischer-344 rats were not only greater than 1000 ppm ppm but
also greater than 1/10th of maximum saturated vapor concentration of ECH at 20c which is calculated to be 17,100 ppm. - Executive summary:
The purpose of this study was to determine the single-exposure 1-hr LC50 of epichlorohydrin (ECH) in Fischer-344 rats. These data were requested in response to recently proposed Department of Transportation (DOT) guidelines that would require additional labeling for the transportation of any liquid whose 1 -hr LC50 values in male and female rats are: 1) less than or equal to1000 ppm; and 2) less than or equal to 1/10th of the liquid's theoretical saturated vapor concentration at 20°C.
Six rats/sex/exposure level were exposed to time-weighted average (TWA) analytical concentrations of 552, 1008, 1970 or 3995 ppm (2.088, 3.814, 7.453 or 15.114 mg/l, respectively) ECH vapors for 1 -hr. Two additional groups of 6 male rats each were also exposed to TWA concentrations of 2865 or 3275 ppm (10.839 or 12.390 mg/l, respectively). The 1-hr LC50 for male rats was estimated to be 3617 ppm. As calculated by the moving average method of analysis, the LC50 for females was 2165 ppm.
Based on the results of this study, ECH does not meet the proposed DOT criteria that would require additional labeling for transportation. The 1-hr LC50 values of ECH were not only greater than 1000 ppm, but also greater than 1/10 of the maximum saturated vapor concentration of ECH at 20°C (calculated to be 17,100 ppm).
Reference
Six rats/sex/exposure level were exposed to time-weighted average (TWA) analytical concentrations of 552, 1008, 1970 or 3995 ppm (2.088, 3.814, 7.453 or 15.114 mg/l, respectively) ECH vapors for l-hr. Two additional groups of 6 male rats were also exposed to TWA concentrations of 2865 or 3275 ppm (10.839 or 12.390 mg/l, respectively). The l-h r LC50 for male rats was estimated to be 3617 ppm. For females, a l-h r LC50 of 2165 ppm was calculated by the moving average method of analysis. Eye and nasal irritation, respiratory difficulty and secretion of a reddish, porphyrin-like material on the facial area were noted among rats exposed to 1970, 2865, 3275 or 3995 ppm, Hyperactivity, followed by lethargy and a cyanotic appearance were also noted in rats exposed to 3275 or 3995 ppm, Although a temporary body weight loss was evident in almost all exposure groups, all rats that survived a 2 -week observation period steadily gained weight. Bilateral corneal cloudiness was the only exposure-related lesion noted among animals (males only) surviving to scheduled necropsy.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 114 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results. Study does not meet guideline requirements for minimum number of animals/dose level. .
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The dermal LD50 was examined using epichlorohydrin, neat, or diluted with propylene chloride with rabbits. Animals were observed until they died or regained pre-treatment weight.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at Study Initiation: 2.43-3.50 kg
- Type of coverage:
- occlusive
- Vehicle:
- other: Dosed undiluted and as a 20% solution in propylene glycol
- Details on dermal exposure:
- Single dose
Area Covered: Unknown
Occlusion: Impervious cuff held in place with cloth bandage taped to hair
Removal of Test Material: Washing with soap and water 24 hours post-dosing
Maximum Volume Administered: 2.38 ml
Post-Dose Observation Period: 2 weeks - Duration of exposure:
- 24 hours
- Doses:
- Undiluted: 100, 200, 465, 795 mg/kg
20% solution in propylene glycol: 252, 500, 630 or 795 mg/kg - No. of animals per sex per dose:
- 2/sex/dose
- Control animals:
- no
- Details on study design:
- Approximately 24 hours prior to dosing, the hair was removed from the trunk of 2 laboratory white rabbits/dose level with electric clippers. The test material was applied at 100, 200, 465, or 795 mg/kg body weight under an impervious cuff held in place with a cloth bandage taped to the hair.
Following application the animals were returned to holding cages and allowed to eat and drink ad libitum. Following a 24-hour exposure period, the cuffs were removed and the skins washed with soap and water. The animals were observed during and after exposure and weighed at intervals up to two weeks post-application. The animals were then submitted for necropsy examination at death or at scheduled study termination. - Statistics:
- LD50 calculation method not specified
- Preliminary study:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 515 mg/kg bw
- Remarks on result:
- other: Undiluted
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 250 - 500 mg/kg bw
- Remarks on result:
- other: 20% solution in propylene glycol
- Mortality:
- Undiluted
# Dead/# Treated
Dose Male Female
(mg/kg)
100 0/2 0/2
200 0/2 0/2
465 1/2 0/2 Found dead 24 hours post-dosing
795 2/2 2/2 Found dead 24 hours post-dosing
20% solution in propylene glycol
# Dead/# Treated
Dose Male Female
(mg/kg)
252 0/2 0/2
500 2/2 2/2 Found dead 24-48 hours post-dosing
630 - 2/2 Found dead 24 hours post-dosing
795 - 2/2 Found dead 24 hours post-dosing - Clinical signs:
- other: Severe redness and swelling and slight necrosis were observed when the cuffs were removed after the 24-hour exposure to either test material.
- Gross pathology:
- no data
- Other findings:
- no additional information available
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Based on the results of the study LD50 for undiluted epichlorohydrin was 515 mg/kg and for the 20% solution in propylene glycol was between 250 and 500 mg/kg.
- Executive summary:
Two male and two female rabbits per dose level were exposed to undiluted epichlorohydrin or a 20% solution of epichlorohydrin in propylene glycol in acute percutaneous absorption tests. The LD50 for undiluted epichlorohydrin was 515 mg/kg and for the 20% solution in propylene glycol was between 250 and 500 mg/kg epichlorohydrin. Propylene glycol may enhance the toxicity of epichlorohydrin by this route as in the previous Dow Test.
Survivors dosed at 200 mg/kg and higher of either solution required 3 to 6 weeks to regain pre-treatment weight; animals dosed at 100 mg/kg required 2 to 3 weeks to regain pre-treatment weight. Severe redness and swelling and slight necrosis were observed when the cuffs were removed after the 24-hour exposure to either test material.
Reference
Two male and two female rabbits per dose level were exposed to undiluted epichlorohydrin or a 20% solution of epichlorohydrin in propylene glycol in acute percutaneous absorption tests. The LD50 for undiluted epichlorohydrin was 515 mg/kg and for the 20% solution in propylene glycol was between 250 and 500 mg/kg epichlorohydrin. Propylene glycol may enhance the toxicity of epichlorohydrin by this route as in the previous Dow Test.
Survivors dosed at 200 mg/kg and higher of either solution required 3 to 6 weeks to regain pre-treatment weight; animals dosed at 100 mg/kg required 2 to 3 weeks to regain pre-treatment weight. Severe redness and swelling and slight necrosis were observed when the cuffs were removed after the 24-hour exposure to either test material.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 515 mg/kg bw
Additional information
Legislation has placed epichlorohydrin in a Category 3 in the GHS classification system.
Justification for classification or non-classification
Epichlorohydrin was moderate to high in toxicity based on oral, dermal and inhalation exposure and thus meets the definition of a Category 3 in the GHS classification system.
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.