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EC number: 208-719-3 | CAS number: 539-48-0
- 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/corrosion:
Two studies are available.
One study was conducted according to OECD 404, exposure for 4 hours and the test substance is corrosive to rabbit skin. This is assigned as key study.
Another study was performed with 3 mins and 1 hour, the test item is moderately irritating to rabbit skin.
Eye irritation:
Study waived as corrosive to skin.
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 2000-02-22 to 2000-03-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Batch No.: Lot. 4
Purity: 99.9% - Species:
- rabbit
- Strain:
- other: Japanese white rabbits KbL:JW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd
- Age at study initiation: 10-week
- Weight at study initiation: 2.2-2.5 kg
- Housing: Animals were housed in an animal room. Animals were placed in suspension-type metallic cages, one per cage, on a z-type water washing rabbit rack.
- Diet: Animals were given free access to pellet food RC-4
- Water: Animals were given free access to water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 6
- Photoperiod (hrs dark / hrs light):12-hour light/12-hour dark - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 g of test chemical moistened with 30 μL of distilled water was applied to rabbit skin.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap: The area was covered with 2-layer gauze, to complete a closed patch.
REMOVAL OF TEST SUBSTANCE
- Washing : Treated areas were cleaned with gauze moistened with water.
OBSERVATION TIME POINTS: Treated areas were observed 30-60 minutes after removing the test chemical and 24, 48 and 72 hours after completing exposure.
SCORING SYSTEM:
- Method of calculation: Erythema and edema observed in 3 rabbits were scored 30-60 minutes and 24 and 72 hours after removing the test chemical and means of scores obtained in 3 rabbits were calculated. Sums of mean scores obtained 30-60 minutes and 24 and 72 hours after removing the test chemical were divided by 3, i.e., the number of evaluation time points (30-60 minutes and 24 and 72 hours), to obtain primary irritation indices (P.I.I.) as a parameter of the severity of irritation. Severity of primary dermal irritation was rated based on the P.I.I. value. This grading method will not be used, however, if the test chemical is evaluated as corrosive. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: impossible to grade at 24, 46 and 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: impossible to grade at 24, 46 and 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: impossible to grade at 24, 46 and 72h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: impossible to grade at 72h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: impossible to grade at 46h and 72h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: impossible to grade at 46h and 72h
- Irritant / corrosive response data:
- Treated skin areas turned grey-white in color and necrotic, showing slight edema, in all 3 animals 30-60 minutes after 4-hour exposure, and hemorrhage was noted on the edge of treated area. Necrotic areas turned brownish-red and became dry and hard 24 hours after completion of exposure. Eschar formation was observed in these areas 6 days after completion of exposure. Eschar exfoliated in one rabbit 22 days after completion of exposure, leaving ulcerative skin in the exfoliated area with subcutaneous tissue visible in skin defect areas. Another rabbit also showed eschar exfoliation with ulcers in exfoliated areas. The third rabbit did not show eschar exfoliation. All 3 rabbits were observed for 30 days after completion of exposure, but heal with scar formation did not occur in any of them.
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test chemical was considered to be a corrosive substance.
- Executive summary:
A primary dermal irritation study of test item was conducted in accordance with OECD Test Guideline No. 404 (1981).
The test item was locally applied to the back skin (round area of about 6 cm2) of Japanese white rabbits for 4 hours, and the skin was observed with the naked eye over time after completion of exposure.
Treated skin areas of all 3 rabbits turned grey-white and became necrotic showing slight edema 30-60 minutes after exposure for 4 hours. Hemorrhage was noted on the edge of treated area. Necrotic areas turned brownish-red and became dry and hard 24 hours after completion of exposure. Crust formation was observed in these areas 6 days after completion of exposure. Crusts exfoliated in one rabbit 22 days after completion of exposure, leaving ulcerative skin with subcutaneous tissue visible in skin defect areas. Another rabbit also showed crust exfoliation with ulcers in exfoliated areas. The third rabbit did not show crust exfoliation. All 3 rabbits were observed for 30 days after completion of exposure, but heal with scar formation did not occur in any of them.
On the basis of these findings, the test item was considered to be a corrosive substance.
Reference
Dermal reactions caused by test item in rabbits
Number of rabbits (weight) |
5 (2.2 Kg) |
6 (2.4 Kg) |
7 (2.5 Kg) |
|||||||||||||
Dermal reactions |
Er |
Ed |
Ne |
Es |
Sc |
Er |
Ed |
Ne |
Es |
Sc |
Er |
Ed |
Ne |
Es |
Sc |
|
Time after completion of exposure |
30-60 min |
/ |
2 |
4 |
0 |
0 |
/ |
2 |
4 |
0 |
0 |
/ |
2 |
4 |
0 |
0 |
24 h |
/ |
1 |
4 |
0 |
0 |
/ |
1 |
4 |
0 |
0 |
/ |
1 |
4 |
0 |
0 |
|
46 h |
/ |
1 |
4 |
0 |
0 |
/ |
/ |
4 |
0 |
0 |
/ |
/ |
4 |
0 |
0 |
|
72 h |
/ |
/ |
4 |
0 |
0 |
/ |
/ |
4 |
0 |
0 |
/ |
/ |
4 |
0 |
0 |
|
6 d |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
4 |
0 |
|
7 d |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
4 |
0 |
|
15 d |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
4 |
0 |
|
22 d |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
/ |
0* |
/ |
/ |
/ |
4 |
0 |
|
28 d |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
/ |
0* |
/ |
/ |
/ |
/ |
0* |
|
30 d |
/ |
/ |
/ |
4 |
0 |
/ |
/ |
/ |
/ |
0* |
/ |
/ |
/ |
/ |
0* |
*: ulcer
/: impossible to grade
Er: erythema
Ed: edema
Ne: necrosis
Es: eschar
Sc: scar
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation/corrosion:
Exposure for 4 hours, corrosive showed in all 3 animals in 24 hours. Exposure for 1 hour and 3 mins did not result corrosive.
According to Regulation (EC) No 1272/2008, table 3.2.1, this substance is classified as Skin corrosive Category 1B.
Serious eye damage/eye irritation:
This substance is skin corrosive.
According to Regulation (EC) No 1272/2008, section 3.3.2.3, Skin corrosive substances shall be considered as leading to serious damage to the eyes as well (Category 1). Hence this substance is classified as Irreversible effects on the eye (Category 1).
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.
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