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Diss Factsheets
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EC number: 205-793-9 | CAS number: 151-56-4
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.001 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 25 000
- Modified dose descriptor starting point:
- T25
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
DNEL acute/short-term exposure, systemic effects:
A DNELacuteshould be established for substances if an acute hazard toxicity (leading to C&L) has been identifiedanda potential for high peak exposures exists.
The substance is classified as very toxic after oral, dermal and inhalation exposure. However, as there is no potential for high peak exposures, acute DNELs do not need to be established.
DNEL short-term/long-term exposure, local effects:
Ethylenimine is classified as corrosive (Classification according to Directive 67/548/ EEC: corrosive, R34; classification according to CLP (Directive 1272/2008): Skin corrosion Category 1 and Serious eye damage/eye irritation Category 1). The corresponding in vivo skin and eye irritation/corrosion tests were performed at one dose level. Therefore, the tests do not provide dose-response data that could be used for the derivation of a DNEL. Also, no quantitative human data on skin corrosion and eye damage (concentration) were available. Furthermore, as no exposure is expected due to the highly accepted use of suitable personal protective equipment and as it can be assumed that, as a rule, daily repeated immediate skin contact is avoided to a large extent by using suitable personal protective equipment, a DNEL has not been derived.
DMEL long-term exposure, systemic effects:
As ethylenimine is classified as carcinogenic and showed tumour development in a carcinogenicity study in rats, a long-term DMEL has to be established. In this hazard evaluation, the key study to be used to determine the chemical’s hazard is an one-year inhalation carcinogenicity study in rats (BASF AG, 1978). This study provides a sound basis for determining the hazard of ethylenimine.
The most significant effect was considered to be the development of uterus/vagina sarcomas. Based on this effect and its incidence, the T25 was determined to be 17.8 mg/m3.
Therefore, the inhalation DMEL for long-term exposure - systemic effects for workers has been derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
T25: 17.8 mg/m3 |
Incidence of uterus/vagina sarcomas (BASF AG, 1978) |
Step 2) Modification of starting point |
1.5
0.67 |
Correction for difference in exposure time (6 h/8 h x 5 d/5 d x 52 w/48 w x 75 y/40 y)
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3). |
Step 3) Assessment factors |
|
|
Interspecies |
1 |
No allometric scaling has to be applied as an inhalation study is used as starting point (concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat's ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and human are to be taken into account). |
Intraspecies |
1 |
No assessment factor applied because of the non-threshold effect (mutagenic & carcinogenic). |
Exposure duration |
1 |
Already corrected for under step 2. |
Dose response |
1 |
|
Quality of database |
1 |
|
Risk level to be estimated |
25000 |
For workers 10-5 |
DMEL |
Value |
|
For workers |
(17.8 mg/m³ x 1.5 x 0.67) / (1 x 1 x 1 x 1 x 1 x 25000) =0.000716 mg/m3(approx. 0.001 mg/m³) |
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Exposure to the general population is not expected, and therefore a DNEL and/or DMEL has not been established.
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.