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EC number: 601-489-9 | CAS number: 1176-81-4
- 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
Fluocortolone-A-acetate is not irritating to the skin of rats (Stark and Wick, 1998) and slightly irritating to the eyes of rabbits (Stark, 1998).
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:
- July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
- Principles of method if other than guideline:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion (comparable to OECD TG 402 and 404). The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint. As described in ATP 96/54/EC ANNEX IV A, PART B: METHODS FOR THE DETERMINATION OF TOXICITY AND OTHER HEALTH EFFECTS, a strategy of testing for irritancy allows the non-performance of a test if an acute toxicity study by the dermal route has been conducted at the limit test dose with the substance (method B.3), and no skin irritation was observed, further testing for skin irritation (method B.4) may be unnecessary.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: males: 278-282 g; females: 204-207g
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): ad libitum pell. Altromin® R
- Water (e.g. ad libitum): ad libitum demineralized acidified water, pH 2-3
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 64-66
- Photoperiod (hrs dark / hrs light):12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: liquid paraffin
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 556-564 mg/male animal or 408-414 mg/female animal
VEHICLE
- Amount(s) applied (volume or weight with unit): 556 and 564 mg + 0.6 ml vehicle
556 mg + 0.5 ml vehicle
408-414mg + 0.5 ml vehicle- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: not reported
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
OBSERVATION TIME POINTS
day 1, 7 and 14
SCORING SYSTEM:
According to Annex I no. 1 of "Gefahrstoffverordnung, Verordnung zum Schutz vor gefährlichen Stoffen ( Gefahrstoffverordnung- GefStoffV), 6. Aufl., Stand Aug. 96 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg bw (556-564 mg/male and 408 -414 mg/female applied as a paste) was tolerated without any local irritations. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0. Therefore, local application of ZK 47525 (fluocortolone-A-acetate) was tolerated without irritation of the skin.
- Executive summary:
In a primary dermal irritation study equivalent to OECD test guideline 404, young adult Wistar rats (3/sex) were dermally exposed to 556 and 564 mg + 0.6 mL vehicle, 556 mg + 0.5 mL vehicle, 408-414mg + 0.5 mL vehicle of Fluocortolone acetate (100% a.i.) in liquid paraffin for 24. Animals then were observed for 14 days. Irritation was done according to the system recommended in Directive 67/548/EEC.
A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg bw (556-564 mg/male and 408 -414 mg/female applied as a paste) was tolerated without any local irritations. The mean values of findings relevant for classification (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
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:
- Oct 1998
- 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:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- 4 instead of 3 animals
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg
- Weight at study initiation: males: 3.3 - 4.1 kg; females: 3.7 - 3.9 kg
- Housing: individually in metal cages under conventional conditions
- Diet (e.g. ad libitum): pell. Altromin® K ad libitum
- Water (e.g. ad libitum): demineralized water ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 60-62
- Photoperiod (hrs dark / hrs light):12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye, which remained untreated, served as control.
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL corresponding to 39.3 - 42.6 mg
- 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
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: according to guideline
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Chemosis score was not determined, reddening and swelling was only investigated for the iris
- 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:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.37
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Interpretation of results:
- GHS criteria not met
- 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 conjunctival reddening and/or swelling on study days 2 and 3. On day 4 (72 h after end of exposure) 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, 0.37 for conjunctival reddening as well as 0.08 for conjunctival swelling. According to EU classification criteria ZK 47525 (fluocortolone-A-acetate) need not be labelled as an eye irritant.
- Executive summary:
In a primary eye irritation study according to OECD test guideline 405 (1987), 0.1mL Fluocortolone acetate (100% a.i.) was instilled into the conjunctival sac of the left eye of young adult New Zealand White rabbits (2/sex). Animals then were observed for 4 days. Irritation was scored by the method recommended by the guideline.
The single administration of 0.1 ml Fluocortolone acetate (= 39.3 - 42.6 mg) into the conjunctival sac of the left eye led to slight to moderate reddening and slight to severe swelling of the conjunctivae on the administration day. On days 2 and 3, only slight reddening and/or swelling was observed. On day 4, all animals were without finding. According to the system of evaluation recommended for EU (1), the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 tor the cornea and iris, 0.33 for conjunctival reddening and 0.08 for the conjunctival swelling., thus, Fluocortolone acetate does not need to be classified according to Regulation 1272/2008 (CLP) with regard to eye irritation.
Reference
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) |
1 | 1 | 0 | 0.67 | |
Conjunctiva (swelling) |
0 | 0 | 0 | 0.0 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 0 | 0 | 0.33 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 0 | 0 | 0.33 | |
Conjunctiva (swelling) | 1 | 0 | 0 | 0.33 |
The control eyes were without findings.
The single application of 0.1 mL ZK 47525 (corresponding to 39.3 - 42.6 mg) into the conjunctival sac of the left eye led to slight to moderate reddening and slight to severe swelling of the conjunctivae on the administration day 1. On days 2 and 3 only slight reddening and/or swelling was observed. On day 4 (72 h after end of exposure) all 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 single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg bw (556-564 mg/male and 408 -414 mg/female applied as a paste) was tolerated without any local irritations (Stark and Wick, 1998). The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0. Therefore, local application of fluocortolone-A-acetate was tolerated without irritation of the skin.
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 conjunctival reddening and/or swelling on study days 2 and 3 (Stark, 1998). On day 4 (72 h after end of exposure) 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, 0.37 for conjunctival reddening as well as 0.08 for conjunctival swelling. According to EU classification criteria fluocortolone-A-acetate need not be labelled as an eye irritant.
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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