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EC number: 603-894-6 | CAS number: 135108-88-2
- 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
Endpoint summary
Administrative data
Description of key information
Based on the key study, the oral LD50 of the test substance in rats is > 50 - 300 mg/kg (Evonik_Stockhausen, 2005).
The dermal LD50 in rabbits is >700 mg/kg (no deaths were observed, but necrotic skin and severe edema was noted in males and females).
Testing for dermal toxicity at higher doses is not warranted as the material is corrosive to the skin.
No data is available regarding acute inhalation toxicity. A data waiver is claimed.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-02-14 to 2005-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2004)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: White Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: White WISTAR, Harlan Winkelmann, Borchen, Germany
- Weight at study initiation: 165.2 - 199.0 g, about 9 weeks
- Fasting period before study: maximum 20 hours
- Diet: Altromin, rat diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 8 times
- Illumination: 12 hours artifical fluorescent light and 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose: 300 mg/kg/bw (applied as 10 % w/w) and 50 mg/kg bw (applied as 5 % w/w)
- DOSAGE PREPARATION: dispersion in sesame oil
- Starting dose 300 mg/kg bw, next step 50 mg/kg bw - Doses:
- 300 mg/kg/bw and 50 mg/kg bw
- No. of animals per sex per dose:
- 3 female at 300 mg/kg
6 female at 50 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: periodic intervals on the dayof dosing and once daily thereafter, until day 15
- Body weight: days 1 (pre-administration) 8 and 15
- Necropsy: Animals died ahead of schedule were necropsied immediately, all survived animals were necropsied at the end of the observation period - Statistics:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Mortality:
- 300 mg/kg: 2 of 3 female rats died within 20 minutes after application
50 mg/kg: no mortality - Clinical signs:
- other: 300 mg/kg: 2 of 3 female rats showed ataxia, decreased respiration, gasping, side position and convulsion, died within 20 minutes after application 50 mg/kg: no toxic symptoms were observed
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no other findings
- Conclusions:
- The LD50 cut-off for VESTAMIN EP-HS 10 was estimated to be 300 mg/kg. Ranking of the test substance VESTAMIN EP-HS 10 according to the Global Harmonised System resulted in Category 3: > 50 - 300 mg/kg
- Executive summary:
The acute oral toxicity study of VESTAMIN EP-HS 10 was determined with 9 female WISTAR rats. Animals were observed for symptoms of clinical toxicity and mortality for 14 days after treatment. At first 3 female rats were treated with 300 mg/kg bw. Two rats showed ataxia, decreased respiration, gasping, side position and convulsion and died within 20 minutes after application. Necropsy immediatley after the death showed no substance related morphological visible pathologic organ findings. The remaining animal showed no toxic symptoms . After that, 2 groups of 3 female rats were dosed with 50 mg/kg. No toxic symptoms were observed and no death occurred. No apparent changes were found in body weights of remaining rats. All survived animals showed
no substance related morphological visible pathologic organ findings.
The LD50 cut-off for VESTAMIN EP-HS 10 is 300 mg/kg. Ranking of the test substance VESTAMIN EP-HS 10 according to the Global Harmonised System resulted in Category 3: > 50 - 300 mg/kg
Reference
no other information
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 300 mg/kg bw
- Quality of whole database:
- The study is valid without restriction (Klimisch 1).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 40CFR Part 158 Series 81-2, EPA Pesticide Assessment Guidelines. F 1984
- Deviations:
- no
- Principles of method if other than guideline:
- The test substance was dosed at a level of 1.0 g/kg. A group of animals (5 male 5 female) with healty intact skin was used. The substance was applied to approxinately 10% of the body surface.of each animal. The dressings were removed after 24 hours and observed over a period of 14 days for any sign of toxicity.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The New Zealand White rabbit, weighing 2.0 to 3.0 kg, was used for this study. The animals were obtained
from Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License #23-BL).
The animals were individually housed and maintained in accordance with standards set forth in the Guide for
the Care and Use of Laboratory Animals (NIH Publication No. 86-23). The rabbits were acclimated to the
laboratory for at least 5 days prior to dosing.
Temperature: 60°F - 75°F
Relative Humidity: 30-80%
Light: 12 hour light/dark cycle
Diet: Wayne 15% Rabbit Ration and tap water were provided ad libitum. Based on our current
knowledge, no contaminants are known to be in this diet or water which might be expected to
interfere with the objectives of the study.
Caging: Stainless steel elevated wire mesh flooring, 1 rabbit/cage.
The animals were individually identified by an ear tag and each cage was identified with a cage card. - Type of coverage:
- occlusive
- Vehicle:
- other: Isopropanol
- Details on dermal exposure:
- The test article was dosed as supplied, at a dose level of 1.0 g/kg
A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. Approximately 24 hours before
testing, the fur was clipped from the backs of the test animals.
All rabbits were weighed and the correct amount of test article was applied to approximately 10% of the
body surface on each animal. The treated area was covered with a large porous gauze patch and wrapped
with an occlusive material and held in place with an elastic bandage to ensure that the animal did not
ingest the test article. The dressings were removed after 24 hours and any excess material removed, where
practical, using water or an appropriate solvent. - Duration of exposure:
- 24 hours
- Doses:
- 1 g/kg
- No. of animals per sex per dose:
- 5 male
5 female - Control animals:
- no
- Details on study design:
- The animals were observed for a 14 day period, for signs of toxicity (systemic and topical) and for
mortalities. Animals were observed frequently during the first day of dosing, and twice per day (morning
and afternoon) on weekdays. On weekends and holidays, animals were observed once per day.
Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. The
animals were euthanized using T-61@ at the conclusion of the observation period. Gross necropsies were
performed on all animals. - Statistics:
- no data available
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Males: Necrotic skin and severe edema was noted after unwrapping at 24 hours. At 7 days 5/5 animals exhibited necrotic skin and severe edema. At 14 days, 3/5 animals exhibited necrotic skin and severe edema, 1/5 animals exhibited peeling necrotic skin and
- Gross pathology:
- No gross abnormalities were noted for 5/5 males necropsied at the conclusion of the 14 day observation period.
No gross abnormalities were noted for 5/5 females necropsied at the conclusion of the 14 day observation period. - Other findings:
- none
- Conclusions:
- The acute dermal toxicity of Formaldehyde, polymer with benzenamine, hydrogenated appears to be greater than 700 mg/kg. At this dose level the test material was corrosive to skin but no mortalities occurred.
- Executive summary:
Formaldehyde, polymer with benzenamine, hydrogenated when dosed at a 70% concentration in isopropanol and studied in male and female albino rabbits combined was corrosive to the skin and had an acute dermal LD50 >1000 mg/kg.
The LD50 in male and female rabbits, based on the substance (formaldehyde, polymer with benzenamine, hydrogenated) appears to be >700 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 700 mg/kg bw
- Quality of whole database:
- Test procedure in accordance with national standard methods with acceptable restrictions (Klimisch 2).
Additional information
Key study shows that the oral LD50 of formaldehyde, polymer with benzenamine, hydrogenated in rats is > 50 - 300 mg/kg (Evonik_Stockhausen, 2005).
The dermal LD50 in rabbits is >700 mg/kg (no deaths were observed, but necrotic skin and severe edema was noted in males and females)
(Reilly, 1988). Testing for dermal toxicity at higher doses is not warranted as the material is corrosive to the skin.
Justification for selection of acute toxicity – oral endpoint
The acute oral toxicity study by Eicler et al (Evonik_Stockhausen, 2005) is a fully acceptable key study (Klimisch1) with a LD50 cut off value of 300 mg/kg bw.
There are three other acute oral toxicity studies available with indications of toxicity near the cut off value of 300 mg/kg bw.
After taking account all available data and considering the most sensitive study amongst the valid ones, ranking the test substance according to GHS is resulted in Cat 3: > 50 - 300 mg/kg bw.
Justification for classification or non-classification
Based on the results of the acute oral toxicity studies and according to the Globally Harmonized Classification System (GHS) the test item is classified in the hazard category 3, required labelling with 'Danger' and 'Toxic if swallowed'. According to the EC Regulation 1272/2008 and subsequent regulations, the test item required labelling with 'Danger' and 'H301: Toxic if swallowed'.
As the test substance is corrosive to the skin, classification for dermal toxicity is not warranted based on the available data.
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