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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 June 2015 to 12 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of daily mean relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- 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:
- 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 substance storage At room temperature
Stable under storage conditions until 26 February 2019 (expiry date)
CAS Number: 9003-80-9
pH: (1% in water, indicative range) 7.76 – 7.37 (determined by WIL Research Europe B.V.)
Molecular structure, formular and weight: UVCB
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC)Source: Charles River Deutschland, Sulzfeld, Germany.Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.Age and body weight: Young adult animals (approx. 10-11 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.Identification: Earmark and tail markHealth inspection: At least prior to dosing. It was ensured that the animals were healthy and without any abnormality that might affect the study integrity.ConditionsEnvironmental controls for the animal room are 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 is between 07:00 and 19:00 hrs daily. The light/dark cycle may be interrupted for study related activities. Any variations to these conditions will be evaluated and maintained in the raw data.Accommodation: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).Acclimatization period was at least 5 days before start of treatment under laboratory conditions.Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).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.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- Method: Oral gavage, using plastic feeding tubes. The test item preparations were stirred on a magnetic stirrer during dosing.Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.Frequency: Single dosage on Day 1.Dose level (volume): 2000 mg/kg (10 mL/kg) body weight.
- Doses:
- Single dose adminstered by oral gavage on day 1
- No. of animals per sex per dose:
- 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals each given 2000 mg/kg (10 mL/kg) body weight.
- Control animals:
- not specified
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
- Statistics:
- The oral LD50 value of the test substance was ranked within the following ranges: 0-5, 5-50, 50-300 or 300-2000 mg/kg b.w. or as exceeding 2000 mg/kg b.w. The LD50 cut-off value was established based on OECD guideline 423. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (including all amendments) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortaility occurs
- Clinical signs:
- Hunched posture and/or uncoordinated movements were noted for all animals on day 1
- Body weight:
- The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
Mortality data
TEST DAY |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
HOURS AFTER TREATMENT |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical signs
TEST DAY |
Max grade |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
HOURS AFTER TREATMENT |
|
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FEMALES 2000 MG/KG Animal 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait / motility. Uncoordinated movements |
(3) |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur. Piloerection |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait / motility. Uncoordinated movements |
(3) |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur. Piloerection |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait / motility. Uncoordinated movements |
(3) |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur. Piloerection |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture: Hunched posture |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture: Hunched posture |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture: Hunched posture |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- Sign not observed
Body weight gain
Sex/Dose level |
ANIMAL |
DAY 1 |
DAY 8 |
DAY 15 |
FEMALES 2000 MG/KG |
|
|
|
|
1 |
186 |
206 |
218 |
|
2 |
177 |
191 |
205 |
|
3 |
174 |
204 |
211 |
|
MEAN |
179 |
200 |
211 |
|
ST.DEV. |
6 |
8 |
7 |
|
N |
3 |
3 |
3 |
|
1 |
193 |
212 |
221 |
|
2 |
187 |
209 |
215 |
|
3 |
199 |
216 |
226 |
|
MEAN |
193 |
212 |
221 |
|
ST.DEV. |
6 |
4 |
6 |
|
N |
3 |
3 |
3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Formaldehyde, oligomeric reaction products with acetone and diphenylamine in Wistar rats was established to exceed 5000 mg/kg body weight.
- Executive summary:
The aim of the test was to assess the toxicity of the test substance when administered orally in a single dose to female rats. The test was conducted in accordance to:
Organization for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4, Health Effects. No. 423, "Acute Oral Toxicity - Acute Toxic Class Method", 2001.
Commission Regulation (EC) No 440/2008 Part B: Methods for the Determination of Toxicity and other Health Effects; B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method". Official Journal of the European Union No. L142, May 2008, including the most recent amendments.
United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.1100, Acute Oral Toxicity. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-02-190, 2002.
Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions.
In conclusion the test concluded that the oral LD50 value for Formaldehyde, oligomeric reaction products with acetone and diphenylamine was established to exceed 2000 mg/kg/bw. No mortalities occurred, however, there were clinical signs such as hunched posture, piloerection and/or uncoordinated movements were noted for all animals on Day 1. The body weight gain shown by the animals was considered to be similar to that expected for normal untreated animals of the same age and stain. No abnormalities were found at macroscopic post mortem examination of the animals.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
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 acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances 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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