Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 424-820-7 | CAS number: -
- 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:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Testing was carried out to GLP standards in accordance with OECD guideline 404. Some details on test material are missing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- and EU Method B4 (Acute Dermal Irritation/Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HRP Inc, Denver, PA
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.39 kg
- Housing: Singles housed in suspended stainless steel wire mesh.
- Diet: Agway Certified Diet R.C.A Rabbit (Agway Inc, Waverly, NY) Ad libitum
- Water: Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C
- Humidity (%): 40 to 60%
- Air changes (per hr): Not stated.
- Photoperiod (hrs dark / hrs light): 12 hours light (07:00 to 19:00) 12 hours dark (19:00 to 07:00).
IN-LIFE DATES: From: To: 1996-05-06 to 1996-05-20
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL (undiluted test material was adminstered neat) - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours.
- Observation period:
- 14 days.
The animal was examined for viability twice daily Monday to Friday, and once daily on weekends. Body weights were recorded on the day of dosing (Day 0) and at terminal sacrifice (Day 14).
Dermal responses were evaluated at 60 minutes, 24 hours, 48 hours and 72 hours following patch removal, and on Days 7, 10 and 14. - Number of animals:
- 1 Male
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch x 1 inch
- Test Site Preperation: Approximately 24 hours prior to topical adminstration of the test materia, the hair of the rabbit in the area of the dorsal surface from the shoulder region to the lumbar region was closely clipped with an electric clipper. The skin was left intact. An elizabethan-type collar was placed around the neck of the rabbit at this time to acclimiate him to wearing a collar. The animal was reclipped as necessary. The collar remained on the animal for approximately 29.5 hours.
- Adminstration of Test Material: The test material was administered as three 0.5 mL doses, each introduced under a 1 inch x 1 inch gauze patch, then secured with non irritating tape. Each patch was loosely held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period. After at least 3 minutes of exposure, the dressing and gauze patch were removed from the first site. After at least 1 hour, the dressing and gauze patch were removed from the second site. After at least 4 hours, the dressing and gauze patch were removed from the third test site.
- Type of wrap if used: Gauze patch secured by non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removal of residual test material using peanut oil and a paper towel.
- Time after start of exposure: 3 minutes, 1 hour and 4 hours.
- The collar was removed after the 4 hour exposure.
SCORING SYSTEM: Draize 1959.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hours exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 3 min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- other: 3 min exposure
- Basis:
- animal #1
- Remarks on result:
- other: atonia, lethary skin, exfoliation and desquamation observed
- Irritation parameter:
- other:
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Remarks on result:
- other: blanching, necrosis, eschar, lethary skin, exfoliation and desquamation observed
- Irritation parameter:
- other:
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Remarks on result:
- other: blanching, necrosis, eschar, lethary skin, exfoliation and desquamation observed
- Irritant / corrosive response data:
- This study was conducted to evaluate the dermal irritation and potential corrosivity of three 0.5 ml doses of the test material in the rabbit following 3 minutes, 1 hour, and 4 hours of exposure. Full table of results can be found in attachment 1.
Skin Responses - 3 Minute Exposure
Topical application of the test material elicited very slight erythema at 60 minutes following exposure. Moderate/severe erythema and moderate edema were noted at 24 Hours. At 48 and 72 Hours, well-defined erythema and slight edema were observed. Atonia was also noted at 72 Hours. Irritation decreased asthe study progressed with only very slight erythema being noted on Days 7 and 10.Very slight edema, as well as leathery skin and exfoliation, were noted on Day 7.Desquamation was noted on Days 10 and 14. There was no evidence of erythema
or edema on Day 14.
Skin Responses - 1 Hour Exposure
Severe erythema and edema (ranging from very slight to severe) were noted at every scoring interval. Necrosis was noted at 60 minutes and at 24, 48, and 72 Hours. Blanching was noted at 60 minutes and 24 Hours. Leathery skin was noted at 48 and 72 Hours and on Day 14. Eschar was noted on Days 7, 10, and 14. Desquamation was noted on Days 10 and 14, and exfoliation was noted on Day 7.
Skin Responses - 4 Hour Exposure
Severe erythema and edema (ranging from very slight to severe) were observed from the 60 minute interval to Day 7. Severe erythema persisted on Day 10, but no edema was noted. Irritation decreased by Day 14 when only very slight erythema and edema were noted. Necrosis was noted at 60 minutes and at 24, 48, and 72 Hours. Blanching was noted at 60 minutes and 24 Hours. Leathery skin was noted at 48 and 72 Hours, and on Day 10. Eschar was noted on Days 7 and 10. Exfoliation was noted on Day 7 and desquamation was noted on Days 10 and 14. - Other effects:
- Overt signs of corrosivity (blanching and/or necrosis) were observed in this animal at the 1 hour and 4 hour exposure sites at 60 minute, 24, 48 and 72 hour dermal evaluations. There was no sign of corrosivity at the three minutes exposure site during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion the test material was corrosive under the conditions of this study.
- Executive summary:
This study was conducted in order to evaluate the dermal irritation and potential corrosivity of the test material in the rabbit.
The test material was administered as three 0.5 ml doses introduced under separate gauze patches to one animal. The patches were secured with non-irritating tape and were loosely held in contact with the skin by means of a semi-occlusive dressing. Exposure duration of each dose site varied, with one of the three dressings remaining in place for either three minutes, one hour, or four hours. After the appropriate exposure was completed, the dressing and gauze were removed. Residual test material was removed using peanut oil and paper towels. Each test site was graded for erythema, edema and other signs of dermal irritation at 60 minutes, 24, 48, and 72 Hours after patch removal, and on Days 7, 10 and 14. All dermal scoring was made according to the Draize method (Draize, 1959).
In an attempt to minimize animal pain and distress, only one animal was initially dosed at all three exposures sites. Since this animal showed signs of corrosivity (blanching/necrosis) no other animals were dosed as per the OECD guideline 404. The one dosed animal was observed for 14 days to evaluate fully the reversibility or irreversibility of the effects observed.
The animal survived to study termination on Day 14, displayed an increase in body weight, and was not observed with any unusual clinical signs.
Overt signs of corrosivity (blanching and/or necrosis) were observed in this animal at the 1 Hour and 4 Hour exposure sites at the 60 minute, 24, 48, and 72 Hour dermal evaluations. There was no sign of corrosivity at the three minutes exposure
site during the test period.
At the four hour exposure site, severe erythema and edema (ranging from very slight to severe) were observed from the 60 minute to Day 7 observation intervals. Severe erythema persisted, but no edema was noted on Day 10. Irritation decreased by the Day 14 observation when only slight erythema and edema were noted. In addition to blanching and necrosis, other supplemental dermal observations at the 4 hour site included desquamation, exfoliation, leathery skin and eschar. The irritation observed at the 1 Hour exposure was essentially equivalent to the irritation seen at the 4 Hour exposure. Irritation observed at the 3 minute exposure was slightly reduced and there were no apparent signs of corrosivity.
In conclusion, the test material was corrosive under the conditions of this study.
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.
Ačkoli agentura ECHA poskytuje on-line velké množství materiálů ve vašem jazyce, část této stránky je bohužel k dispozici pouze v angličtině. Další podrobností o postupu agentury ECHA při zveřejňování informací v různých jazycích.
Vítejte na internetových stránkách agentury ECHA. Tyto stránky nejsou plně podporované v prohlížeči Internet Explorer 7 (a starších verzích). Aktualizujte si prohlížeč Internet Explorer na novější verzi.
Tato webová stránka používá cookies, aby se vám naše stránky používaly co nejlépe.
Více informací o tom, jak používáme soubory cookies.