Registration Dossier
Registration Dossier
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: 824-458-3 | CAS number: 1263679-68-0
- 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
In-vivo studies are available for both skin and eye irritation, and thus in-vitro studies are waived.
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:
- October 30th, 2018 - February 27th, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Additional tests at 3 min and 1hr exposure time as well as exposure of 2 animals for 4 hours according to OECD 404
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- HCFO-1233yd(Z)
Purity 92.5%
7.3% (E)-1-chloro-2,3,3-trifluoropropene
0.2% unknown impurity
stable at room temperature
Expiry date Oct 17th, 2019 - Species:
- rabbit
- Strain:
- other: Japanese White (Jla:JW)
- Remarks:
- female animals - more easily handled. No sex differences in skin irritation responses.
- Details on test animals or test system and environmental conditions:
- Age at start of test 16 weeks, 3 females. Received into the test facility at 14 weeks and allowed 14 days to acclimatise before commencement of the test. Body weight range 3.22-3.86 kg. Normal weight gain and good dermal condition before start of test. Potential contaminants in feed were
within acceptable range. Animals were maintained within a room 21-25 deg Centigrade and humidity
38-77%, with air exchange 11-14 times per hour, lighting from 07:00-19:00 each day. Animals were accommodated individually in aluminium cages 560(W)x 550(D) x 410mm(H) and allowed free access to LRC4 pelleted diet for rabbits and guinea pigs (Lot 180828 Oriental Yeast Co.) and tap water on automatic supply. Environmental enrichments were provided according to IUCAC recommendations. - Type of coverage:
- other: Nichiyu Linseed Oil Paper;
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5mL unmodified (no vehicle)
- Duration of treatment / exposure:
- 3 min, 1hr, 4hr
- Observation period:
- 14 days
- Number of animals:
- 1 animal for 3 min, 1 animal for 1 hour, 3 for 4 hour exposure (initially 1 animal then a further 2 animals).
- Details on study design:
- At step 1, the pre-clipped dorsal area of 1 animal was divided into 4 application areas. 0.5ml of the test substance was uniformly put on a 2.5x2.5 cm lint sheet (Nishio Eisei Zairyo Co Ltd), on the applied side, Nichiyu Linseed Oil Paper (Nichiyu Co. Ltd) and applied to the application site A. The patch was covered with Tegaderm tape (3M Healthcare) and fixed. After 3 minutes, the patch on the application site A was removed and the site wiped with cotton soaked with water for injection (Lot 7C92, Otsuka Pharmaceutical Factory Inc.).
At step 2 the test substance was applied in the same manner as step 1, but left in place for 1 hour, then removed and the site (B) wiped as above.
At step 3, the test substance was applied to application site C in the same manner as above, with a control (untreated) patch applied to application site D. After application, all application sits were covered with a lint sheet and the area wrapped with self-adhesive elastic bandage (3M Coban Self-adherent wrap, 3M health care) and fixed by polyethylene film tape (Keepore A; Nichaban Co. Ltd). After 4hours of application, patches on the application sites were removed and the sites wiped with cotton soaked with water for injection, as above.
At step 4, the day after after steps 1-3, the pre-clipped dorsal areas of 2 new animals were both divided into right and left along the median line and 2 application sites, E and F, were designated. The test substance was applied to the application site E in the same manner as the first application in steps 1-3. A control patch 2.5 cm x 2.5 cm was applied to application site F. After application, the patch was covered with tape, wrapped in self adhesive elastic bandage and fixed by polyethylene film tape. After 4 hours of application. Patches were all removed and the sites wiped with cotton and water for injection as above.
Observation and measurement was performed on day 3, day 4 and day 10.
Animals were observed for clinical signs immediately after each application and at 1hr after removal of application for the animals in step 1-4; From the day following application, clinical signs were observed once each day until the final observation day (day 3 (animal 1103), day 4 (animal 1101) or day 10 (animal 1102).
Dermal reactions were observed at 1, 24, 48 and 72 hr after removal of the patch(es). Thereafter observations were performed once daily until dermal reactions disappeared in the animal (up to day 10 after application at the longest). For steps 1 and 2, observations were only continued up to 72 hours. Dermal reactions erythema or oedema were scored and recorded according to Draize's Criteria (1959). After the final observation, animals were euthanized by an overdose of pentobarbital sodium (Somnopentyl, Kyoritsu Seiyaku Corporation).
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- P.I.I. 2.0 moderate irritant. By the GHS classification the test substrance was judged as not classified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Results showed fully reversible erythema and edema in 3 female Japanese White rabbits; slight edema reversible within 72 hours across all animals; moderate to severe erythema reversible within 10 days for one animal, well-defined erythema fully reversible within 3-4 days for the other two animals. Based on the above results the test substance showed no corrosion to rabbit dermis and was judged as a "moderate irritant" according to Primary Irritation Index criteria and as "not classified" according to GHS criteria under the conditions of this study.
- Executive summary:
Exposure of Japanese white rabbits to the test substance for 4hr resulted in moderate erythema and mild edema, fully reversible. The test substance is classified as a moderate irritant according to the Primary Irritation Index and "not classified" according to GHS criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30/10/2018 - 19/11/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Japanese White (Jla:JW)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- Single administration followed by closing the eyelid for 1 second.
- Observation period (in vivo):
- 1, 3 and 6 hours after treatment, for 4 days.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the above results, HCFO-1233yd(Z) showed no corrosion to rabbit eye and it was judged as "Mildly irritating" and regarded as ''Not classified" according to the GHS classification under the conditions of this study.
- Executive summary:
The eye irritation/corrosion potential of the HCFO-1233yd(Z) (the test substance) was examined in Japanese White rabbits (lla:JW, female). The test substance (0.1 mL) was applied to the left eye of one (initial test) and two animals ( confirmatory test), and the eye reactions were observed for the longest 96 hours after application and the eye corrosion/irritation potential was evaluated. The results are summarised as follows:
There were no corrosive changes in any animal during the observation period. Conjunctival redness, chemosis and discharge were observed in 3/3 or 2/3 animals at 1 hour after application. Eye irritation reactions were alleviated with the passage of time and all changes disappeared by 96 hours after application. The maximum mean total score (MMTS) was recorded at 1 hour after application and the value was 7.3. In the evaluation by the Kay and Calandra classification, the value of mean total score at 48 hours after application (MTS 48) was 0.7 and higher than 0, thus the test substance was classified as "Mildly irritating". In the evaluation of irritation by the GHS classification criteria, the test substance was regarded as ''Not classified" since there were no animals that showed positive response for corneal opacity (degree), iritis, conjunctival redness or chemosis. There were no abnormalities in clinical signs or body weight of any animal.
Based on the above results, HCFO-1233yd(Z) showed no corrosion to rabbit eye and it was judged as "Mildly irritating" and regarded as ''Not classified" according to the GHS classification under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation
Results showed fully reversible erythema and edema in 3 female Japanese White rabbits; slight edema reversible within 72 hours across all animals; moderate to severe erythema reversible within 10 days for one animal, well-defined erythema fully reversible within 3-4 days for the other two animals. Based on the above results the test substance showed no corrosion to rabbit dermis and was judged as a "moderate irritant" according to Primary Irritation Index criteria and as "not classified" according to GHS criteria under the conditions of this study.
Eye Irritation
The eye irritation/corrosion potential of the HCFO-1233yd(Z) (the test substance) was examined in Japanese White rabbits (lla:JW, female). The test substance (0.1 mL) was applied to the left eye of one (initial test) and two animals (confirmatory test), and the eye reactions were observed for the longest 96 hours after application and the eye corrosion/irritation potential was evaluated. The results are summarized as follows:
There were no corrosive changes in any animal during the observation period. Conjunctival redness, chemosis and discharge were observed in 3/3 or 2/3 animals at 1 hour after application. Eye irritation reactions were alleviated with the passage of time and all changes disappeared by 96 hours after application. The maximum mean total score (MMTS) was recorded at 1 hour after application and the value was 7.3. In the evaluation by the Kay and Calandra classification, the value of mean total score at 48 hours after application (MTS 48) was 0.7 and higher than 0, thus the test substance was classified as "Mildly irritating". In the evaluation of irritation by the GHS classification criteria, the test substance was regarded as ''Not classified" since there were no animals that showed positive response for corneal opacity (degree), iritis, conjunctival redness or chemosis. There were no abnormalities in clinical signs or body weight of any animal.
Justification for classification or non-classification
The available data indicates that classification for both skin and eye irritation is not warranted.
HCFO-1233yd(Z) is not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.