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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-506-9 | CAS number: 96-45-7
- 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
Ethylene thiourea is not irritating to the eyes or the skin of rabbits and the respiratory tract of rats.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001/02/26 - 2001/05/08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and toxicology kg
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: singly in special restrainers with dimensions of 425 mm x 6000 mm x 380 mm which allowed free movement of the head but prevented a complete body turn.
- Diet (e.g. ad libitum): altromin 2023, available before and after the exposure period.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 55+/-15%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg ETU per patch per animal, once epicutaneous
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24-48-72 hours
- Number of animals:
- 3 rabbits (males)
- Details on study design:
- TEST SITE
- Area of exposure: dermal application to the shaved intact dorsal skin
- % coverage: 6 cm²
- Type of wrap if used: a gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Any reaction was observed: erythema score and edema score were equal to 0 at all time.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
- Conclusions:
- Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg ETU per patch and animal showed any substance-related lesions at the examination time-points 60 min and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
ETU was non-irritating to skin, hence, no labelling is required. - Executive summary:
The aim of this examination was to examine ETU for acute skin irritation in rabbits (patch test). After the 4 -hour exposure period, the patch was removed and the skin sites of the three animals were evaluated.
Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg ETU per patch and animal showed any substance-related lesions at the examination time-points 60 min, and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Restriction : no data on purity, no quantitative data for ETU
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no score are available.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Japanese white (females)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka, Japan
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing: in metal cages (39 x40x44 cm)
- Diet (e.g. ad libitum): RC4 diet (Oriental Yeast Co., Tokyo Japan), ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/-1°C
- Humidity (%): 55+/-5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- The chemical (Solid = 100 mg ; liquid = 0.1 ml) was placed into conjunctival sac of the left eye.
The right eye was served as a blank. - Duration of treatment / exposure:
- 1 single administration
- Observation period (in vivo):
- 1, 4, 24, 48, 72, 96 hr, and 7, 14, 21 days after the treatment of chemical.
- Number of animals or in vitro replicates:
- 3 animals/ group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE : no data
SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize score (1944). - Irritation parameter:
- overall irritation score
- Remarks:
- Draize score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- <= 7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Minimal irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritant / corrosive response data:
- There was no quantitative data for ETU.
It was a chemical which inducing no or mild damage recovering within 24 hr. This score distributed from 0 up to 7.0 . - Other effects:
- no
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- ETU was in class I, it was a non or mild irritant.
- Executive summary:
The Draize eye irritation test has been used as an attempt to predict ocular irritancy of chemicals.The eye irritation ratings were made in three classes on the basis of the recovery time of corneal and conjunctival damages. A three-class discrimination was made as follows; class I included chemicals which induced the damages recovering within 24 hr, class II included chemicals which induced the damages persisting for more than 24 hr but recovering within 21 days, class III included chemicals which induced the damages not recovering within 21 days. ETU was a non or mild irritant (class 1).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The acute skin irritation in rabbits (patch test) of ethylene thiourea was evaluated in an OECD guideline # 404 study (Leuschner, 2003). After the 4 -hour exposure period, the patch was removed and the skin sites of the three animals were evaluated. None of the three rabbits exposed for 4 hours to 500 mg ethylene thiourea per patch and animal showed any substance-related lesions at the examination time-points 60 min, and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
Eye irritation
A Guideline study with acceptable restrictions was available for eye irritation (Sugai 1990). This study used 3 rabbits and one dose of ethylen e thiourea (100 mg / 1 ml). The Draize eye irritation test has been used as an attempt to predict ocular irritancy of chemicals. Score of ethylene thiourea distributed from 0 up to 7.0 , but there were no quantitative data.
Respiratory irritation .
In the 28-day inhalation toxicity study performed according to the OECD guideline # 412 (Duchosal et al., 1988), no clinical and histological sign of nasal and lung irritation was observed up to the concentration of 0.197 mg/l.
Justification for classification or non-classification
No classification is warranted for skin and eye irritation according to Regulation (EC) No 1272/2008.
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.