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EC number: 241-442-6 | CAS number: 17418-58-5
- 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:
- June 2nd to 9th, 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- not specified
- Remarks:
- Test performed according to the Proposed Guideline, Federal register, Vol. 43, n. 163, August 22nd, 1978
- GLP compliance:
- no
Test material
- Reference substance name:
- Disperse Red 060
- IUPAC Name:
- Disperse Red 060
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: individual housing in metal cages
- Diet: NAFAG, no. 814, Gossau SG, standard rabbit food, ad libitum
- Water: ad libitum
- Acclimation period: 4 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: propylene glycol + saline (70:30 parts)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 % - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 h, 48 h, 72 h, 4 d and 7 d after patch removal
- Number of animals:
- 6 animals: 3 male and 3 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Assessment
Due to intensive staining by the test substance, erythema was not assessable. For the purpose of calculating the primary irritation index, erythema was assumed to be equal to edema based on existing correlation (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).
Skin reaction scores of rabbits
Abraded skin
Animal/sex | Reaction | 24 h | 48 h | 72 h | 4 d | 7 d | Mean 24, 48 and 72 h |
19 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
20 M | Erythema | 1 | 0 | 0 | 0 | 0 | 0.33 |
21 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
22 F | Erythema | 1 | 0 | 0 | 0 | 0 | 0.33 |
23 F | Erythema | 1 | 0 | 0 | 0 | 0 | 0.33 |
24 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
19 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
20 M | Oedema | 1 | 0 | 0 | 0 | 0 | 0.33 |
21 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
22 F | Oedema | 1 | 0 | 0 | 0 | 0 | 0.33 |
23 F | Oedema | 1 | 0 | 0 | 0 | 0 | 0.33 |
24 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
Intact skin
Animal/sex | Reaction | 24 h | 48 h | 72 h | 4 d | 7 d | Mean 24, 48 and 72 h |
19 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
20 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
21 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
22 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
23 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
24 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
19 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
20 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
21 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
22 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
23 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
24 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non-skin irritant.
- Executive summary:
The substance was tested for skin irritation potential based on the Proposed guidelines of the US EPA 163.81 -5 "Primary dermal irritation study," Federal register, Vol. 43, No. 163, August 22, 1978 (1980). 0.5 g of test substance was applied to 2.5 cm × 2.5 cm intact and abraded skin in an occlusive preparation to 3 male and 3 female New Zealand White rabbits. 50 % solution of propylene glycol + saline (70:30 parts) was the vehicle used. The exposure duration was 24 h. Animal skin reactions were scored at 24 h, 48 h, 72 h, 4 d and 7 d after patch removal.
One male and two female rabbits showed slight edema and slight erythema on abraded skin at 24 h only. These skin reactions were reversible within 48 h. No skin reactions were observed on intact skin.
Abraded skin of all six animals had the following mean reaction scores (24, 48 and 72 h): erythema score < 1 and oedema score < 1.
Intact skin of all six animals had the following mean reaction scores (24, 48 and 72 h): erythema score = 0 and oedema score = 0.
Therefore, the test substance is a non-skin irritant.
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