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EC number: 607-988-8 | CAS number: 2668-75-9
- 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
Skin irritation (Rat): not irritating to skin [Schering AG, Report No. X112 -draft-, 1996-09-26]
Eye irritation (Rabbit, OECD TG 405): not irritating to the eye [Schering AG, Report No. X144 -draft-, 1996-08-22]
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:
- December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Principles of method if other than guideline:
- Combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume1.0-1.1 ml) to male and female rats; semi-occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 30-60 min after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- occlusive
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is not irritating to skin
- Executive summary:
A combined study on acute dermal toxicity and on local tolerance was conducted. The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of this endpoint.
Approximately 209 mg/male rat and 192 mg/female rat was applied as a paste on the skin and left for 24 hours under occlusive conditions. Subsequently the bandage and the test substance was removed, and the skin areas were assessed according to the system recommended in directive 67/548/EEC. The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
Reference
The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
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
- Study period:
- February 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Chemical name: 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
ZK no.: 5560
Batch no.: 25031900
CAS no.: 002668-75-9
Purity: >77% (according to certificate of analysis no.: 92/8145, dated 24 Nov. 95 and re-analysis report 976014, dated 17.07.97) - Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- other: The left eye, which remained untreated, served as control.
- Duration of treatment / exposure:
- test substance remained in the eye - eye was not rinsed
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to the eye.
- Executive summary:
The single applictaion of 0.1 ml undiluted test substance into the eye of 4 rabbits results in slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings. The scores relevant for classification according to Regulation (EC) No 1272/2008 were for the time-points 24, 48 and 72 hours 0 for cornea, iris and chemosis and 0.7 at maximum for conjunctiva/redness.
Reference
A single application of 0.1 ml undiluted test substance into the conjunctival sac led to slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A combined study on acute dermal toxicity and on local tolerance was conducted. The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion.
Approximately 209 mg/male rat and 192 mg/female rat was applied as a paste on the skin and left for 24 hours under occlusive conditions. Subsequently the bandage and the test substance was removed, and the skin areas were assessed according to the system recommended in directive 67/548/EEC. The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
The single applictaion of 0.1 ml undiluted test substance into the eye of 4 rabbits results in slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings. The scores relevant for classification according to Regulation (EC) No 1272/2008 were for the time-points 24, 48 and 72 hours 0 for cornea, iris and chemosis and 0.7 at maximum for conjunctiva/redness.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
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