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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-331-5 | CAS number: 68424-95-3
- 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: dermal
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 3rd March 1987 - 17th March 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- The dosages were changed to: Group Treatment Level (mg/kg bw) 1 552 2 1104 3 3328 4 4448
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Specific details on test material used for the study:
- Substance was stored at room temperature at all times.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Suspended stainless steel wire mesh bottom cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days prior to initiation of study.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 10% v/v solution of ethanol/water.
- Details on dermal exposure:
- On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each rabbit. The exposed area on the trunk of each animal measured approximately 12x20 cm and constitutred 10% of the animal's total body surface. On the following day, the appropriate material was applied uniformly over the exposed skin, or as much of the area as possible. An occlusive binder was secured around the trunk of each animal immediately after treatment.
- Duration of exposure:
- 24 hours.
- Doses:
- 552, 1104, 3328 or 4448 mg/kg bw.
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for mortality and toxic effects for 8 hours after dosing and daily thereafter until day 15. Particular attention was given to observations of tremours, convulsions, seizures, lethargy and other signs of cardiac and/or central nervous system toxicity. Individual body weights were determined on days 1, 8 and 15 or at death.
- Necropsy of survivors performed: yes. Animals which died during the study were also subjected to a gross necropsy examination at the time of death or when found dead. During necropsy examinations, particular attention was directed to abnormalities of the heart and its auxialiary vascular system.
- Statistics:
- LD50 was calculated using the Probit Analysis method.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 861 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 0 - < 4 292
- Mortality:
- Individual mortality data is presented below in the table.
No deaths occurred among the vehicle control animals. - Clinical signs:
- No clinical effects related to the treatment with the vehicle were noted.
The substance was irritating to the skin in all animals at all doses, these effects were characterised by eschar formation at the treatment sites within 24 hours after administration.Adverse effects were first noted at the 1104 mg/kg bw group when compared to controls. Reduced faecal production was present throughout the test population within 72 hours post administration and lasted for 1 to 4 days. One animal also displayed decreased activity, nasal discharge, mucoid excretions, an apparent bloody snout, faecal stains of the haircoat and soft stools. A second animal from this dose level displayed mucoid excretions and nasal discharge. In the higher dose levels these effects were more prevalent and the reduced faecal production was extended in duration. These events were often accompanied by emaciation and late deaths. Decreased activity was more prevalent in all animals and random but significant clinical findings included prostration, ataxia, tremours, laboured breathing and mucoid excretions. Isolated findings in one to three animals included nasal discharge, apparent bloody snouts, rales, soft stools, faecal/urine stains of the haircoat and anogenital areas. - Body weight:
- A decrease in mean body weight was observed in all treatment groups in a dose response relationship. At the lowest level a minimal weigh loss (3-127 g) was observed in some 70% animals on day 8. The weight loss was a transient event and recovery to control levels was observed by day 15. At increasing dose levels, the incidence of weight loss within each test population, the amount of weight loss and the delayed recovery to control levels increased. At 1104 mg/kkg bw dose level the weight lost between days 1 and 8 was only partially recovered by day 15. At the two higher dose levels, the weight loss persisted in survivors.
By contrast, the mean body weight of male and female vehicle control animals increased at each measurement interval. - Gross pathology:
- Gross necropsy findings were minimal. There was an increased incidence of pale kidneys in animals at the highest treatment level as compared to controls.Distended atria and/or ventricles were also noted in three animals at the highest dose levels.One animal in the 3328 mg/kg bw treatment group was noted to have a heavily pigmented gel in the large intestine.
Any other information on results incl. tables
Mortality data:
Treatment | Dose level | No. of Deaths/No. Dosed | ||
Males | Females | Sexes Combined | ||
10% Ethanol/Water | 5.56 ml/kg bw |
0/5 | 0/5 | 0/10 |
Substance (80% active) | 552 mg/kg bw | 0/5 | 0/5 | 0/10 |
1104 mg/kg bw | 0/5 | 0/5 | 0/10 | |
3328 mg/kg bw | 3/5 | 2/5 | 5/10 | |
4448 mg/kg bw | 5/5 | 3/5 | 8/10 |
Applicant's summary and conclusion
- Conclusions:
- The acute dermal toxicity of the substance is 3342 mg/kg bw in the rabbit. The substance was a corrosive as evidenced by adverse signs at the site of application.
- Executive summary:
In an acute dermal toxicity study an 80% solution of the substance was administered to New Zealand White rabbits (5 animals/sex/dose) by occlusive dressing at a dose levels of 552, 1104, 3328 or 4448 mg/kg bw (single administration). The exposure was for 24 hours after which the animals were observed for 14 days and observed for mortlaity, signs of clinical toxicity, changes to body weight gain and gross pathology was conduted at necropsy. There was dose-dependent mortalities and signs of clinical toxicity. A decrease in mean body weight was observed in all treatment groups in a dose response relationship. Gross necropsy findings were minimal. There was an increased incidence of pale kidneys in animals at the highest treatment level as compared to controls.Distended atria and/or ventricles were also noted in three animals at the highest dose levels.One animal in the 3328 mg/kg bw treatment group was noted to have a heavily pigmented gel in the large intestine. The acute dermal toxicity of the substance is 3342 mg/kg bw in the rabbit. The substance was a corrosive as evidenced by adverse signs at the site of application.
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.