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EC number: 276-115-7 | CAS number: 71873-39-7
- 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 / corrosion, other
- Remarks:
- in vivo
- Type of information:
- other: read across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June from 9th to 16th, 1993
- 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:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- similar substance 1, AR336
- IUPAC Name:
- similar substance 1, AR336
Constituent 1
- Specific details on test material used for the study:
- The test material was used as supplied.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately 12 to 16 weeks old.
- Weight at study initiation: 2.32 - 2.36 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: mains food RABMA Rabbit Diet, ad libitum.
- Water: mains drinking water, ad libitum.
- Acclimation period: minimum 5 days.
- Health check: on the day before the tes,t each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 23 °C
- Humidity: 58 - 74 %. On one occasion the humidity was above the limit specified in the protocol (70 %).
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of the test material, moistened with 0.5 ml of distilled water
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- Two males and one female
- Details on study design:
- TEST SITE
- Area of exposure: on the day of the test a suitable test site was selected on the back of each rabbit. The test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
- Type of wrap if used: the patch was secured in position with a strip of surgical adhesive tape (approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Removal: any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water followed by diethyl ether.
- Time after start of exposure: 4 hours.
SCORING SYSTEM
Approximately one hour following the removal of the patches and 24,48 and 72 hours later, the test sites were examined for evidence of primary irritatin and scored according to the scale from Draize J.H. (1959) Association of Food and Drug Officials of the united states, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
An additional observation was made on day 7 to assess the reversibility of skin reactions.
The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material. If irreversible alteration of the dermal tissue is noted in any rabbit, which may include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin.
Ervthena and Eschar Formation
No erythena 0
Very stight erythena (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythena 3
Severe erythena (beet redness) to slight eschar formation (injuries in depth) 4
Oedena Formation
No oedena 1
Very slight oedena (barely perceptible) 1
Slight oedena (edges of area well-defined by definite raising) 2
Moderate oedena (raised approxinately 1 millimetre) 3
Severe oedena (raised more than 1 millimetre and extending beyond the area of exposure) 4
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
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Pink-coloured staining caused by the test material was noted at all treated skin sites following patch removal. The staining did not affect evaluation of erythema.
Very slight erythema was noted at all treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at two treated skin sites at the 24 and 48-hour observations. Well-defined erythema persisted at one treated skin site at the 72-hour observation.
Very slight oedema was noted at two treated skin sites one hour after patch removal with very slight or slight oedema at 24-hour observation. Slight oedema persisted 72-hour observations.
Skin reactions noted at all treated skin sites seven days after treatment were crust formation or desquamation.
Any other information on results incl. tables
INDIVIDUAL DERMAL REACTIONS
Animal |
Reaction | Time After Treatment | Mean 24/48/72 hrs | ||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | |||
Female n. 168 | Erythema/Eschar | 1 STA | 2 STA | 2 STA | 2 STA | 0CfSTA | 2.00 |
Oedema | 1 | 2 | 2 | 2 | 0 | 2.00 | |
Male n. 169 | Erythema/Eschar | 1 STA | 1 STA | 1 STA | 0STA | 0DSTA | 0.66 |
Oedema | 1 | 1 | 0 | 0 | 0 | 0.33 | |
Male n. 171 | Erythema/Eschar | 1 STA | 0STA | 0STA | 0STA | 0DSTA | 0.00 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 |
STA: pink-coloured staining
Cf: crust formation
D: desquamation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used that described in the OECD Guidelines 404. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight to well-defined erythema and very slight to slight oedema. Skin reactions noted at all treated skin sites seven days after treatment were crust formation and desquamation.
The test material produced a primary irritation index of 1.7 and was classified as a mild irritant to rabbit skin, according to the Draize classification scheme. No corrosive effects were noted.
Conclusion
The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP (EC 1272/2008) Regulation.
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