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EC number: 211-995-8 | CAS number: 734-32-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 December 2019 - 16 April 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The additional test in skin irritation was performed based on the Guidance on Environmental Management Registration of New Chemical Substances (Order No. 12 of the MEE of the P.R. China). The in vivo test was the accepted method of the toxicological endpoint skin irritation/corrosion at the time for a New Chemical Substance Registration in China.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Qualifier:
- according to guideline
- Guideline:
- other: State Ministry of Environmental Protection of the People’s Republic of China. Guidelines of Chemical Testing (HJ/T 153-2004) Annex A 404 Acute Dermal Irritation/Corrosion Test.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Estr-4-ene-3,17-dione
- EC Number:
- 211-995-8
- EC Name:
- Estr-4-ene-3,17-dione
- Cas Number:
- 734-32-7
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estr-4-ene-3,17-dione
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese long-eared white rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Co., Ltd.
- Weight at study initiation: 2.30-2.40 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit maintenance feed (batch no. 19101861) provided by Liaoning Changsheng Biotechnology Co., Ltd., ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.03-23.70 °C
- Humidity (%): 40.71-67.80%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- other: untreeated left side of the spinal column on the back of teh animal served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Two areas of skin on both sides of the midline below the shoulder blade were selected (approximately 2.5 cm x 2.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): ultra-pure water and absorbent cotton were used to wash the skin at the test area
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Immediately after patch removal, 1, 24, 48, 72 h
SCORING SYSTEM:
- Method of calculation: Draize scale
Dermal Irritation Response Score
Skin response Score
Erythema and eschar formation
No erythema 0
Slight erythema (barely perceptible) 1
Clearly visible, easily defined erythema 2
Moderate to severe erythema 3
Severe erythema (purplish-red) to eschar formation 4
Oedema formation
No oedema 0
Slight oedema (barely perceptible) 1
Slight oedema (skin raised, clear outline) 2
Moderate oedema (skin raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- no abnormalities or skin reactions were observed immediately after the dressing was removed, and until 72 hours after the dressing was removed
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, based on observations seen and the assessment system adopted, mean dermal erythema/oedema scores at 24 hours,
48 hours, and 72 hours after the dressings were removed were 0/0, 0/0, and 0/0. Based on the GHS classification criteria for dermal irritation/corrosion, Norandrostendione did not meet the classification criteria. - Executive summary:
In a dermal irritation study equivalent to OECD Guideline 404 three male Japanese long-eared white rabbits were dermally exposed to Norandrostendione. 0.5 g of the test sample was administered to the clipped dorsal skin on the right side of each animal and the dorsal skin on the left side served as the control. Exposure time was four hours. The animals were observed clinically immediately after the dressing was removed and at one hour, 24 hours, 48 hours and 72 hours.
Skin response was observed immediately after the dressing was removed and at one hour, 24 hours, 48 hours and 72 hours, and was scored based on the skin irritation response scoring criteria.In all three animals no abnormalities were observed immediately after the dressing was removed, and until 72 hours after the dressing was removed.
Under the conditions of this test, based on observations seen and the assessment system adopted, mean dermal erythema/oedema scores at 24 hours,
48 hours, and 72 hours after the dressings were removed were 0/0, 0/0, and 0/0. Based on the GHS classification criteria for dermal irritation/corrosion, Norandrostendione did not meet the classification criteria.
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