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EC number: 500-011-5 | CAS number: 9003-80-9
- 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:
- 11 July 2016 to 05 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In the interest of animal welfare and to minimize any testing likely to produce severe responses in animals, a weight of evidence analysis was performed, prior to the start of this in vivo skin irritation study in the rabbit. As recommended in the test guidelines, all available information was evaluated (e.g. existing human and animal data, literature, item data supplied by the Sponsor, analysis of structure activity relationships (SAR), physicochemical properties and reactivity (pH, buffering capacity) and in vitro (BCOP 508841; skin corrosion 508839; skin irritation 508839), ex-vivo and in vivo tests) to determine the need for in vivo skin testing. It was concluded that there is need to perform this in vivo skin irritation study in rabbit in order to establish the possible skin irritating properties of the test item.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Organization for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4, Health Effects, No.404: "Acute Dermal Irritation / Corrosion", Paris, 2015.
- Deviations:
- yes
- Remarks:
- see "Any other information"
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Commission Regulation (EC) No 440/2008 Part B: Methods for the Determination of Toxicity and other Health Effects; B4: "Acute Toxicity: Dermal Irritation/Corrosion". Official Journal of the European Union No. L142, May 2008, including most recent amendments.
- Deviations:
- yes
- Remarks:
- see "Any other information"
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.2500, Acute Dermal Irritation. Office of Prevention, Pesticides and Toxic Items (7101), EPA 712-C-98-196, August 1998.
- Deviations:
- yes
- Remarks:
- see "Any other information"
- GLP compliance:
- yes
Test material
- Reference substance name:
- Formaldehyde, oligomeric reaction products with acetone and diphenylamine
- EC Number:
- 500-011-5
- EC Name:
- Formaldehyde, oligomeric reaction products with acetone and diphenylamine
- Cas Number:
- 9003-80-9
- Molecular formula:
- UVCB substance - not applicable
- IUPAC Name:
- N-phenylaniline; formaldehyde; propan-2-one
- Test material form:
- solid: flakes
- Details on test material:
- 6.1. Test item
6.1.1. Test item information
Identification Formaldehyde, oligomeric reaction products with acetone
and diphenylamine
Appearance Dark brown flakes
Batch IC5B04P006
Purity/Composition 100% Unknown or Variable compositions, Complex reaction products and Biological materials (UVCB)
Test item storage At room temperature
Stable under storage conditions until 26 February 2019 (expiry date)
Constituent 1
- Specific details on test material used for the study:
- Test substance: 206534/AIdentification: Formaldehyde, oligomeric reaction products with acetone and diphenylamineAppearance: Dark brown flakesBatch: IC5B04P006Purity/Composition: 100% Unknown or Variable compositions, Complex reaction products and Biological materials (UVCB)Test substance storage: At room temperatureStable under storage conditions until: 26 February 2019 (expiry date)Chemical names (IUPAC), synonym or trade name: Formaldehyde, oligomeric reaction products with acetone and diphenylamine (BXA)CAS Number: 9003-80-9pH (1% in water, indicative range): 7.76 – 7.37 (determined by Charles River Den Bsoch)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: Albino rabbit, New Zealand White, (SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. EC, OECD) Source: Charles River France, L’Arbresle Cedex, France Number of animals: 3 Males. Age and body weight: At start of dosing, the animals were between 12 and 24 weeks old and body weights were at least 1.5 kg. Identification: Earmark. Health inspection: At least prior to dosing. It was ensured that the animals were healthy and that the skin to be treated was intact and free from any abnormality.Conditions: Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle: the photoperiod was between 07:00 and 19:00 hrs daily. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study. Accommodation: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. Diet: Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period. Water: Free access to tap water. Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: watery ethanol (50% v/v)
- Controls:
- not required
- Amount / concentration applied:
- Each animal was treated by dermal application of 0.5 grams of the test item.
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animalsThe study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 20 days later, after considering the degree of skin irritation observed in the first animal.
- Details on study design:
- Test Item Preparation The test item was ground to a powder using a pestle and mortar prior to weighing and since the test item did not mix with water, the test item was moistened with watery ethanol (50% v/v) (water: Elix, Millipore S.A.S., Molsheim, France; ethanol: Merck, Darmstadt, Germany), immediately before application, to ensure close contact with the animal's skin. No corrections were made for the purity/composition of the test item, since the guidelines require a fixed amount that has to be applied.Treatment Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimetres (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations. Each animal was treated by dermal application of 0.5 grams of the test item. The test item was moistened with 0.6 mL of the vehicle and applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage#. Four hours after the application, the dressing was removed and the skin cleaned of residual test item using tap water. After the final observation, the first animal was sacrificed by intra-venous injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands). The other two animals were removed from the study alive.Observations Mortality/Viability: Twice daily. Toxicity: At least once daily. Body Weight: Day of treatment (prior to application) and on the day of the final observation. Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test item. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.Necropsy: No necropsy was performed according to study plan.Histopathology: No histopathology was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours exposure to Formaldehyde, oligomeric reaction products with acetone and diphenylamine.There was no evidence of a corrosive effect on the skin.
- Other effects:
- Colouration / Remnants: Following exposure, light grey staining of the treated skin area was noted after removal of the test item. No further staining of the treated skin by the test item was observed and no test item remnants were seen. Clinical signs / Mortality: No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual Skin Irritation Scores
Following exposure, light grey staining of the treated skin area was noted after removal of the test item
Animal |
1231 |
143 |
144 |
||||||
Time after exposure |
Erythema (0-4) |
Oedema (0-4) |
Comments |
Erythema (0-4) |
Oedema (0-4) |
Comments |
Erythema (0-4) |
Oedema (0-4) |
Comments |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
1Sentinel
Mean Value Irritation Scores
Animal |
Mean 24, 48 and 72 hrs |
|
|
Erythema |
Oedema |
123 143 144 |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
Animal Specifications
Animal |
Sex |
Age at start
(weeks) |
Body weights (grams) |
|
Prior to application |
After the final observation |
|||
123 143 144 |
M M M |
14 12 12 |
3192 2812 2686 |
3337 2883 2894 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritation was caused by 4 hours exposure to Formaldehyde, oligomeric reaction products with acetone and diphenylamine.
- Executive summary:
Primary skin irritation/corrosion study with Formaldehyde, oligomeric reaction products with acetone and diphenylamine in the rabbit (4-hour semi-occlusive application).
The study was carried out based on the guidelines described in:
OECD No.404, "Acute Dermal Irritation/Corrosion" (2015)
EC, No 440/2008; B4: "Acute Toxicity: Dermal Irritation/Corrosion".
US EPA, OPPTS 870.2500 (1998), Acute Dermal Irritation.
JMAFF Guidelines (2000), including the most recent revisions.
Three rabbits were exposed to 0.5 grams of Formaldehyde, oligomeric reaction products with acetone and diphenylamine, moistened with 50% watery ethanol by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
No skin irritation was caused by 4 hours exposure to Formaldehyde, oligomeric reaction products with acetone and diphenylamine.
Based on these results Formaldehyde, oligomeric reaction products with acetone and diphenylamine does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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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