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EC number: 274-660-5 | CAS number: 70528-90-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The experiment started: January 21, 1980; Experiment and study completion date: 04 February 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile
- EC Number:
- 274-660-5
- EC Name:
- 5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile
- Cas Number:
- 70528-90-4
- Molecular formula:
- C15H12ClN5O4
- IUPAC Name:
- 5-[(4-chloro-2-nitrophenyl)diazenyl]-1-ethyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 36019/D
Purity: 50.2 %
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and slightly scarified
- Vehicle:
- other: Propylene glycol+saline (70:30 parts), concentration 50%
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male and 3 female rabbits
- Details on study design:
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme.
Score for skin irritation in rabbits
Erythema and eschar formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score 4
Edema formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). FAT 36091/D was found to cause a slight irritation when applied to intact and abraded rabbit skin.
Any other information on results incl. tables
Calculation of the primary skin irritation index
The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. (FHSLA § 191.11)
MEAN REACTION SCORE OF 6 RABBITS | |||||
ERYTHEMA | EDEMA | ||||
Time after exposure | Intact skin | Abraded skin | Intact skin | Abraded skin | |
24 hours | 0 | 1.3 | 0 | 1.3 | |
72 hours | 0 | 0.8 | 0 | 0.8 | |
Total | 0 | 2.1 | 0 | 2.1 | 4.2 |
primary irritation index = 4.2 / 4 = 1.1
Assessment of irritation
0 = none
>0 - 1 = minimal
>1 - 2 = slight
>2 - 4 = moderate
>4 - 6 = marked
>6 - 8 = extreme
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 36091/D was found to cause a slight irritation when applied to intact and abraded rabbit skin.
- Executive summary:
The skin irritation in albino rabbits after single application was performed to determine the irritant potency of the test item on the albino rabbit skin. The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) 163.81-5 "Primary dermal irritation study", Federal Register Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female (New Zealand White rabbits), checked for normal skin conditions. Before treatment the flanks of the rabbits were shaved and immediately before treatment, the shaven skin on one side was slightly scarified. A gauze patch bearing 0.5 g of the test substance was applied to the prepared abraded and intact skin. The patches were covered by an impermeable material. Patches were held in place for 24 hours. Observations were made at 24, 48, 72 hours and 7 days, respectively. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). The 24/48/72h mean erythema score and edema score was found to be 0 and 1 respectively. The effects were fully reversible within 7 days of observation period. Under the conditions of the present experiment FAT 36091/D was found to cause a minimal to slight irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 1. FAT 36091/D was found to cause a minimal to slight irritation when applied to intact and abraded rabbit skin. In general, abration represents an elevated test condition that does normally not need to be taken into account for evaluation of the hazard assessment. Therefore, results on abraded skin are not taken into account.
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