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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 807-619-2 | CAS number: 65535-29-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- 4 instead of 3 animals
- GLP compliance:
- yes
- Remarks:
- - but a QA check was not performed
Test material
- Reference substance name:
- 9beta, 11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
- Cas Number:
- 65535-29-7
- Molecular formula:
- C27 H35 F O5
- IUPAC Name:
- 9beta, 11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: males: 2.8-3.3 kg; females: 2.6-3.3 kg
- Housing: Individually in conventional metal cages
- Diet (e.g. ad libitum): pell. Altromin® K ad libitum
- Water (e.g. ad libitum): demineralized water ad libitum
- Acclimation period: > 14 days; during this period a diet containing 0.03%
sulfaquinoxaline was offered for 7 consecutive days as coccidiosis prophylaxis; the animals received Jacutin® emulsion into the meatus acusticus externus for prophylaxis against mite infection of the ear and were vaccinated against rabbit haemorrhagic disease (Arvilap®)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 56-60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Details on study design:
- SCORING SYSTEM: Evaluation of the local tolerance on the conjunctiva of the rabbit after a single application was performed according to the score system recommended for the EU.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1-#4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Remarks on result:
- not measured/tested
- Remarks:
- In the present study only swelling of the conjunctivae was measured, swelling of eye lids and nictating membranes was not reported
Any other information on results incl. tables
Table 1: Results of the study
Irritant effects (score) | |||||
Animal no. (sex) | Irritation parameter | 24 h | 48 h | 72 h | Mean scores |
1 (M) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 2 | 0 | 0 | 0.67 | |
Conjunctiva (swelling) | 3 | 0 | 0 | 1.0 | |
2 (M) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 2 | 1 | 1 | 1.33 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 2 | 1 | 1 | 1.33 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
4 (F) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 2 | 2 | 1 | 1.67 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 |
The control eyes were without findings.
The single application of 0.1 mL ZK 50992 (corresponding to 61-71 mg) into the conjunctival sac of the right eye led to moderate to severe reddening and vascular injection and slight to moderate swelling of the conjunctivae on the administration day 1. Slight to moderate reddening and/or swelling, which gradually subsided were observed up to day 6.
Applicant's summary and conclusion
- Conclusions:
- In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight to moderate reddening and/or swelling, which gradually subsided up to day 6. On day 7 all animals were without findings. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0.0 for the parameters cornea and iris, 1.25 for conjunctival reddening as well as 0.25 for conjunctival swelling. Thus, the test item is not considered as an eye irritant.
- Executive summary:
In a primary eye irritation study according to OECD TG 405 (adopted 24 February 1987), 0.1 mL corresponding to 61-71 mg of Epoxide-Valerate was instilled into the conjunctival sac of the right eye of young adult female and male New Zealand White rabbits (2/sex) and the animals were observed for 7 days. The eyes were not washed. Irritation was scored by the method described in the guideline.
The single application of 0.1 mL of the test item (corresponding to 61-71 mg) into the conjunctival sac of the right eye led to moderate to severe reddening and vascular injection and slight to moderate swelling of the conjunctivae on the administration day 1. Slight to moderate reddening and/or swelling, which gradually subsided were observed up to day 6. In this study, the test item is not an eye irritant.
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.