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EC number: 223-564-1 | CAS number: 3962-66-1
- 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 [Ihara 2004]
Eye irritation (rabbit): not irritating [Takashima 2004]
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:
- from March to April 2003
- 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, rats instead of rabbits, 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:
- other: Jcl:SD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 7 weeks (male), 10-11 weeks (female)
- Weight at study initiation: 257-288 g (male), 264-272 g (female)
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7-22.8
- Humidity (%): 42-57
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shorn
- 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): 514 - 576 mg/male; 528 - 544 mg/female
VEHICLE
- Amount(s) applied (volume or weight with unit): 1mL
- Lot No. 2Y28 - 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: 4 x 9 cm
- % coverage: 10% of body surface
- Type of wrap: gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed out with lukewarm water
- Time after start of exposure: 24 hours
Scoring system: according to OECD404 - Irritation parameter:
- erythema score
- Basis:
- animal: #1 to #6
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: #1 to #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One male and one female revealed very slight reddenings at only 24 hours after removal of the pad (day 3). The mean values of grades across 3 time-points (24, 48 and 72 hours after removal of the pad) and across all 6 animals were 0.1 for reddenings/scab formation and 0 for swelling, and these findings were temporarily observed.
- Other effects:
- No systemic intolerance reactions were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 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. A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg provoked very slight reddenings at only 24 hours after removal of the pad (day 3) which was fully reversible on day 4 (48 hours after removal of the pad) after administration.
- Executive summary:
In a primary dermal irritation study similar to OECD TG 404, (young adult) Jcl:SD rats, female and male (3/sex) were dermally exposed to 514-576 mg/male animal or 528-544 mg/female animal of Delta-5-Norandrostendion in liquid paraffin for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to the system recommended in OECD Test Guideline 404.
No local irritations were observed. In this study, the test item is not a dermal irritant.
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:
- December 2003
- 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:
- other: Kbl:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.93 - 3.18 kg (male), 2.80 - 2.85 kg (female)
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7 - 22.8
- Humidity (%): 45 - 63 %
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL (corresponded to 39-41.8 mg substance)
- 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:
- chemosis score
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The single application of 0.1 mL ZK 67026 into the conjunctival sac of the right eye led to predominantly slight reactions observed within 2 hours after application. The data reveal that conjunctiva was only transiently affected. However, cornea and iris were not affected. Moreover, all animals were without findings 2 hours after application.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- only slight irritation of the conjuntivae which were fully reversible within 2h after application
- Conclusions:
- In a local tolerance test on the rabbit eye similar to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight transient irritation (only 0.5 to 1 hours after application).
- Executive summary:
In a primary eye irritation study similar to OECD TG 405, 0.1 mL corresponding to 39-41.8 mg of Delta-5-Norandrostendion was instilled into the conjunctival sac of the right eye of young adult female and male Kbl:New Zealand White rabbits (2/sex) and the animals were observed for 4 days. The eyes were not washed. Irritation was scored by the method described in the guideline.
A single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to 2 h after application. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling and reddening. In this study, the test item is not an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study similar to OECD TG 404, (young adult) Jcl:SD rats, female and male (3/sex) were dermally exposed to 514-576 mg/male animal or 528-544 mg/female animal of Delta-5-Norandrostendion in liquid paraffin for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to the system recommended in OECD Test Guideline 404.
No local irritations were observed. In this study, the test item is not a dermal irritant.
In a primary eye irritation study similar to OECD TG 405, 0.1 mL corresponding to 39-41.8 mg of Delta-5-Norandrostendion was instilled into the conjunctival sac of the right eye of young adult female and male Kbl:New Zealand White rabbits (2/sex) and the animals were observed for 4 days. The eyes were not washed. Irritation was scored by the method described in the guideline.
A single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to 2 h after application. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling and reddening. In this study, the test item is not 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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