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EC number: 297-025-4 | CAS number: 93281-13-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October from 05 to 12, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12th, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Direct Black 168
- IUPAC Name:
- Direct Black 168
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.
- Age at study initiation: 15 weeks males, 16 weeks females.
- Weight at study initiation: 2.6 kg males, 2.8 kg females.
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: pelleted standard Kliba 341, ad libitum.
- Water: community tap water from Itingen, ad libitum.
- Acclimation: four days under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Humidity: 40 - 70 %.
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark.
- Other: music during the light period, air-conditioned room.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Preparation: the test article was applied moistened with bi-distilled water.
- Amount applied: 0.5 g. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males and 1 female.
- Details on study design:
- TEST SITE
- Area of exposure: approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. Only those animals with no signs of skin injury or irritation were used in the test. On test day the test article was applied to approx. 6 cm2 of the intact skin of the clipped area.
- Type of wrap if used: treated area was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 hours.
OBSERVATIONS
- Viability/Mortality and clinical signs: daily.
- Body Weights: at the start of acclimatization, day 1 of test (application day) and at termination of observation.
SCORING SYSTEM
The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article. The corrosive properties of the test article and the staining of the treated skin area related to the test article were described and recorded.
The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for the irritant properties of a material, and they are viewed as reference values.
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
Maximum possible 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
Maximum possible score 4
Maximum cumulative score: 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Test item showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
A black coloration on the back was observed in all animals from 1 to 72 hours.
No destructions or irreversible alterations of the treated skin were observed; no corrosive effect was evident on the skin. - Other effects:
- CLINICAL SIGNS AND VIABILITY / MORTALITY
No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. Body weight gain of all rabbits was similar. A black coloration on the back was observed in all animals from 1 to 72 hours.
Any other information on results incl. tables
The skin irritation scores for each animal are presented below.
Time period | Animal | Sex | Erythema | Edema | Cumulative score | Mean cumulative score |
1 hr | 69 | M | 0 | 0 | 0 | 0.00 |
70 | M | 0 | 0 | 0 | ||
71 | F | 0 | 0 | 0 | ||
24 hrs | 69 | M | 0 | 0 | 0 | 0.00 |
70 | M | 0 | 0 | 0 | ||
71 | F | 0 | 0 | 0 | ||
48 hrs | 69 | M | 0 | 0 | 0 | 0.00 |
70 | M | 0 | 0 | 0 | ||
71 | F | 0 | 0 | 0 | ||
72 hrs | 69 | M | 0 | 0 | 0 | 0.00 |
70 | M | 0 | 0 | 0 | ||
71 | F | 0 | 0 | 0 |
The mean scores for skin irritation as a mean of 24, 48 and 72 hours are presented below.
Animal | Sex | Erythema | Edema | Cumulative score |
Mean Cumul. Score (24/48/72) |
69 | M | 0.00 | 0.00 | 0.00 | 0.00 |
70 | M | 0.00 | 0.00 | 0.00 | |
71 | F | 0.00 | 0.00 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- The substance is not a skin irritant.
- Executive summary:
The irritancy potential of the test material to the skin of New Zeland white rabbit was assessed, according to the OECD Guideline 404. The intact skin of the rabbits was exposed for 4 hours to the substance, in a semi-occlusive dressing. Animals were examined for signs of erythema and edema and the responses were scored at 1 hour following the patch and substance removal/washing, and then 24, 48 and 72 hours later.
No acute clinical symptoms were observed and no mortality occurred. A black coloration on the back was observed in all animals from 1 to 72 hours, but no signs of irritations were observed. Test item showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
Conclusion
The substance is not a skin irritant.
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