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Diss Factsheets
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EC number: 446-420-1 | CAS number: 474044-10-5
- 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
![](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:
- 08 April 2003 to 18 April 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Identification: HSY-2701
Description: Red powder
Batch: 03A-20
Purity: > 99.9 %
Test substance storage: At room temperature protected from light
Stability under storage conditions: Stable
Expiry date: 07 August 2003 (6 months from the date of receipt).
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Housing: Housed individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 65 x 44 x 37.5 cm)
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx 100 g per day. In addition, pressed hay (BMI, Helmond, the Netherlands) was provided twice a week.
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.8-22.2 °C
- Humidity (%): 58.10 to 79.58 %
- Air changes (per hr):15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: watery ethanol (50 % v/v)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm (dorsal)
- Type of wrap if used: Test material was applied to the skin of one flank, using a metalline patch of 2 x 3 cm. The patch was mounted on Micropore tape; which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water, ethanol and acetone.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
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) 4
* Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
OEDEMA FORMATION
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Four hours exposure to 0.5 g of HSY-2701 resulted in very slight oedema in the treated skin-area of one rabbit.
The skin irritation had resolved within 24 hours after exposure.
There was no evidence of a corrosive effect on the skin - Other effects:
- Yellow/orange staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Individual Skin Irritation Scores
Following exposure, yellow/orange staining of the treated skin-area was noted after removal of the test substance
Animal # |
227 (sentinel) |
219 |
270 |
||||||
Time after exposure |
Erythema |
Oedema |
Comments |
Erythema |
Oedema |
Comments |
Erythema |
Oedema |
Comments |
1 hour |
0 |
1 |
a |
0 |
0 |
a |
0 |
0 |
a |
24 hours |
0 |
0 |
a |
0 |
0 |
a |
0 |
0 |
a |
48 hours |
0 |
0 |
a |
0 |
0 |
a |
0 |
0 |
a |
72 hours |
0 |
0 |
a |
0 |
0 |
a |
0 |
0 |
a |
Comments: a. Yellow/orange staining of the skin by the test substance. |
Table 2: Mean Value Irritation Scores
Animal # |
Mean 24-72 hours |
|
Erythema |
Oedema |
|
227 |
0 |
0 |
219 |
0 |
0 |
270 |
0 |
0 |
# Animal specifications:
Animal no. |
Sex |
Age at start (weeks) |
Body weights (grams) |
|
Prior to application |
At termination |
|||
227 |
Male |
11-13 |
2216 |
2325 |
219 |
Male |
10 -12 |
2441 |
2601 |
270 |
Male |
7-9 |
1671 |
1770 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HSY-2701 was found to be non-corrosive and non-irritating in New Zealand White rabbits.
- Executive summary:
In an OECD guideline study (404) performed in compliance with GLP, the irritation potential of HSY-2701 was determined in three male New Zealand White Rabbits. After four hours of exposure, very slight oedema was noted in 1 animal at 1 hour, however this was fully reversible within 24 hours. Yellow/orange staining of the test site was noted in all animals. HSY-2701 was determined to be non-corrosive and non-irritating to rabbit skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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