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Diss Factsheets
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EC number: 208-778-5 | CAS number: 541-41-3
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Dermal application of small ammounts may be invalid due to high vapor pressure. As no irritating effects have been reported there may have been not any dermal exposure at all. Subcutaneous exposure was only one a week for a relativeley short period of time (22 weeks).
Data source
Reference
- Reference Type:
- publication
- Title:
- Carcinogenicity of acylating agents: Chronic bioassays in mice and structure-activity relationships (SARC).
- Author:
- Van Duurren BL, Melchionne S and Seidman I.
- Year:
- 1 987
- Bibliographic source:
- J Amer Coll Toxicol 6:479-487.
Materials and methods
- Principles of method if other than guideline:
- Ethyl chloroformate was was applied dermally and subcoutanously. The study included a cancer promotion study with PMA
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethyl chloroformate
- EC Number:
- 208-778-5
- EC Name:
- Ethyl chloroformate
- Cas Number:
- 541-41-3
- Molecular formula:
- C3H5ClO2
- IUPAC Name:
- ethyl chlorocarbonate
- Details on test material:
- - Name of test material (as cited): ethyl chloroformate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, indianapolis, IN, USA
- Age at study initiation: 6-8 weeks
- Weight at study initiation:
- Housing: in groups of 6
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): no data
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: the chemical in 0.1 ml acetone was applied thrice weekly for the duration of the test in the interscapular region. After treatment, the mice were housed in hoods for 2-3 hours before being returned to the animal rooms.
- Time intervals for shavings: regular, no interval given
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 3.0; 4.3; 5.5 mg Ethyl chloroformate/administration
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility, penetration enhancer
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 3.0; 4.3; 5.5 mg Ethyl chloroformate/administration - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- After treatment, the mice were housed in hoods for 2-3 hours before being returned to the animal rooms.
- Frequency of treatment:
- thrice weekly
- Post exposure period:
- no
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3.0; 4.3; 5.5 mg Ethyl chloroformate/administration
Basis:
no data
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- Animals were weighed at 30-60-day intervals, and the average body weights of the treated groups were calculated and compared to controls. Tumor observations were made daily and recorded. Animals that became moribund or died during the treatment period or had large tumor masses were killed by cervical dislocation. All mice were necropsied, and routine sections were taken from the area of administration and also of lung, liver, kidney, spleen, colon, and urinary bladder. All other tissues and organs that appeared clinically abnormal were also taken for histopathology. All tissues were fixed in formalin, blocked in paraffin, view of the large and stained with hematoxylin and eosin for histopathology.
- Sacrifice and pathology:
- Organs other than the skin were not examined.
- Statistics:
- yes, but no data concerning the method
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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 examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No skin tumors were observed in groups of 50 animals treated repeatedly on the skin over 18-22 months with 3.0 or 5.5 mg test material. One sarcoma was found in a group of rats treated repeatedly with 4.3 mg test material. The results of this test were not considered to be significant.
An experiment also was conducted in which one dose of test material (5.5 mg) was applied dermally to a group of 50 rats, followed 2 weeks later by repeated dosing with the tumor promoter PMA (3 times weekly until the study was terminated). Whereas 3/30 rat treated with PMA developed skin tumors (2 papilloma and 1 sarcoma), 6/50 rats treated with ethyl chloroformate developed skin tumors (4 papilloma, 2 squamous cell carcinoma). The results of this study were significant at p < 0.05.
An experiment also was conducted in which test material (0.3 or 1.1 mg) was injected subcutaneously once/week over a period of 18-22 weeks. The tumor incidences at each of the concentrations were 1/50 (squamous cell carcinoma) and 0/30, which were not different from the controls [0/30, 2/50 (2 hemangioma, and 0/50]. The results of this test were not considered to be significant.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 5.5 other: mg/traetment
- Sex:
- female
- Basis for effect level:
- other: skin umors
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Applicant's summary and conclusion
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.