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EC number: 609-222-8 | CAS number: 3625-82-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- August 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - 4 instead of 3 animals
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol
- EC Number:
- 609-222-8
- Cas Number:
- 3625-82-9
- Molecular formula:
- C20 H28 O2
- IUPAC Name:
- 3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 ml (corresponded to 61.6 - 62.9 mg test material)
- 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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.08
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.59
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.42
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Local findings after single administration of ZK 46060 into the conjunctival sac of the rabbit eye were slight to moderate reddening of the conjunctivae observed in all animals on administration day up to day 3 (except animal no. 359M only until day 2). Slight to moderate swelling of the conjunctivae was observed in all animals on administration day up to day 2 or 3. In addition, one male and one female animal showed vessel injection of the iris on administration day. The same finding was also observed in the other male animal but only on day 2. All animals were without findings on day 4.
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 |
1 | 0 | 0 | 0.33 | |
Conjunctiva (reddening) |
1 | 1 | 0 | 0.67 | |
Conjunctiva (swelling) |
1 | 0 | 0 | 0.33 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 1 | 0 | 0.67 | |
Conjunctiva (swelling) | 2 | 0 | 0 | 0.67 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 1 | 0 | 0.67 | |
Conjunctiva (swelling) | 1 | 1 | 0 | 0.67 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 1 | 0 | 0.67 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 |
The control eyes were without findings.
Local findings after single administration of ZK 46060 into the conjunctival sac of the rabbit eye were slight to moderate reddening of the conjunctivae observed in all animals on administration day up to day 3 (except animal no. 359M only until day 2). Slight to moderate swelling of the conjunctivae was observed in all animals on administration day up to day 2 or 3. In addition, one male and one female animal showed vessel injection of the iris on administration day. The same finding was also observed in the other male animal but only on day 2. All animals were without findings on day 4.
Applicant's summary and conclusion
- Executive summary:
A single conjunctival administration into the conjunctival sac of the rabbit eye (OECD TG 405) provoked slight to moderate irritation which was fully reversible on day 4 after administration.
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