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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 931-384-6 | 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
![](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:
- 16 March 1990 - 20 April 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study protocol was not in accordance with modern guidelines, which for example would have required fewer animals, but the scientific basis of the method followed is nevertheless robust.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report):
- Substance type: Complex reaction product.
- Physical state: Liquid.
- Analytical purity: Assumed to be 100% for the purpose of dosing.
- Impurities (identity and concentrations): NA.
- Composition of test material, percentage of components: The study report does not contain information on test material characterisation or analysis; it confirms this information is held by the study sponsor Exxon Chemical Company, Paramins Division (now Infineum).
- Lot/batch No.: I.
- Expiration date of the lot/batch: NDA.
- Stability under test conditions: NDA.
- Storage condition of test material: Room temperature.
- Other: pH = 4. A 10% (v/v) mixture of test material in reverse osmosis water was prepared by adding 18 mL water to 2 mL test material. The test material.water mixture was shaken by hand in a closed jar and the pH was measured by immersing a ColopHast pH 0-14 pH paper strip.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA.
- Age at study initiation: Approximately 11 weeks.
- Weight at study initiation: Approximately 2-3 kg.
- Housing: Individually housed in suspended steel cages.
- Diet (e.g. ad libitum): Restricted feeding regimen.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 15 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70ºF (18.3-21.1ºC).
- Humidity (%): Target himudity range was 40-60%. Measured humidity exceeded 60% once during the acclimation period and twice during the study; however, the study authors concluded that these deviations did not adversely affect the study results.
- Air changes (per hr): NDA.
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.
IN-LIFE DATES: From: 20 March 1990 To: 27 March 1990
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Not stated.
- % coverage: Not stated.
- Type of wrap if used: The test material was introduced under a gauze patch which was secured with tape. The patch was loosely held in contact with the skin by means of a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed, where possible, using reverse osmosis water and paper towels.
- Time after start of exposure: Four hours.
SCORING SYSTEM: Dermal responses were scored according to the Draize method (see below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- There were no supplemental dermal observations noted during the study.
Any other information on results incl. tables
Mean erythema and oedema scores at each time interval |
|||||
35 min |
24 hour |
48 hour |
72 hour |
7 day |
|
Erythema |
1.00 |
0.83 |
0.83 |
1.00 |
0.00 |
Oedema |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the findings and the primary irritation index of 0.92, the test material may be considered a mild irritant to rabbit skin.
- Executive summary:
The dermal irritancy potential of the test material was tested in a GLP study in rabbits. 0.5 mL of neat liquid test material was applied under a gauze patch to the shaved dorsal skin of six male New Zealand White rabbits and held in place using a semi-occlusive dressing. After approximately four hours of exposure, the dressing and gauze patch were removed, residual test material washed away using water and paper towels, and the dermal responses scored periodically over the next seven days according to the Draize method.
Erythema responses of 0 (no erythema), 1 (very slight erythema - barely perceptible), or 2 (well-defined erythema) was seen in all animals during the initial 72 hours post-administration. The mean erythema score for the 24 -, 48- and 72 -hour observations was 0.89. By Day 7, there was no erythema in any animal. No oedema was observed at any time and no supplemental dermal observations were noted. A primary dermal irritation index (PII) of 0.92 was calculated. Based on the findings and the PII, the test material may be considered a mild irritant 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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Għalkemm l-ECHA qiegħda tipprovdi ħafna materjal fil-lingwa tiegħek onlajn, parti minn din il-paġna qiegħda bl-Ingliż biss. Sir af aktar dwar il-prattika multilingwa tal-ECHA.
Merħba fuq is-sit web tal-ECHA. Dan is-sit mhux appoġġat b'mod sħiħ fl-Internet Explorer 7 (u l-verżjonijiet aktar bikrin). Jekk jogħġbok aġġorna l-Internet Explorer tiegħek għal verżjoni aktar ġdida.
Dan is-sit web juża l-cookies biex jiżgura li jkollok l-aqwa esperjenza fuq is-siti web tagħna.
Sir af aktar dwar kif nużaw il-cookies.