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EC number: 403-730-1 | CAS number: 2687-96-9
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 02 to 30 March 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is primarily a Comedogenic study and so is conducted at low doses and investigations focussed on dermal reactions. While well run is not considered suitable to address this endpoint in isolation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study method is as FDA (21 CFR Part 58) and FDRL Standard Operating Procedures.
- GLP compliance:
- yes
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Batch No.: 87-0071
Purity: 2% w/v suspension in distilled water
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc.
- Age at study initiation: Young adult.
- Weight at study initiation: 2-3 kg
- Fasting period before study:
- Housing: Individually housed in wire-mesh cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): Fresh tap water was provided ad libitum.
- Acclimation period: At least 5 days prior to study initiation.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: 2 March 1987 To: 30 March 1987
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: distilled water
- Details on exposure:
- A volume of 0.5 mL of the test substance or positive control was applied to the external left ear canal of the appropriate group, 5 days a week for 4 consecutive weeks. Dosing was done at approximately the same time daily. Each dose was evenly distributed over the treatment site using a clean glass stirring rod. The right ear of each animal served as an untreated control.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 days a week for 4 consecutive weeks
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 mL of a 2% aqueous suspension: equivalent to ca. 3-5 mg/kg bw/d
Basis:
nominal per unit area
- No. of animals per sex per dose:
- Six males were assigned to the test group and three to the positive control group.
- Control animals:
- yes
- Details on study design:
- Terminal studies:
All animals were sacrificed on day 29 by intracardiac injection of sodium pentobarbital. Treated and control sites were excised, fixed in 10% neutral buffered formalin, embedded in paraffin, cut in cross section to 5 μm thickness and stained with hematoxylin and eosin. Treated and untreated sites were examined microscopically. Each tissue was assigned a comedogenic grade based on the degree of follicular hyperkeratosis and other morphological changes in the pilosebaceous units according to the system of Morris and Kwan (1983).
A group mean comedogenic grade was then calculated for the test article and positive control materials and the degree of comedogenic activity of each assessed. - Positive control:
- Concurrent positive control group animals were treated with 1% coal tar in Polylan.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Animals were observed daily for signs of toxicity, behavioral abnormalities and general health. Mortality checks were conducted twice daily, at least 5 hours apart.
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Treated and untreated ears were examined daily and the condition and gross appearance of each was noted. This examination was conducted prior to dosing on application days.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded on days 1 and 29.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: No data
- Time schedule for collection of blood:
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood:
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
URINALYSIS: No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, ear canal
HISTOPATHOLOGY: Yes, ear canal - Other examinations:
- None stated
- Statistics:
- None stated
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical signs and Mortality:
All test animals appeared normal throughout the study. One control animal exhibited soft stools on study days 5, 6, 7 and 16. This finding is common among stock laboratory rabbits and is not considered to be of toxicological significance.
Body weight:
Body weights were increased in both groups at day 29.
Dermal irritation:
Treatment with the test substance produced dermal irritation characterized by redness, dryness and flaking.
Pathology:
A comedogenic response was observed at the test site in one of six rabbits used in the test group.
Based on the scoring system used in this study, the group of animals treated with the test substance had a mean comedogenic grade of 0.5. One of six test animals received a comedogenic grade of 3.
Effect levels
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: The purpose of this test is to determine a mean comedogenic grade.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Study is primarily a Comedogenic study and so is conducted at low doses and investigations focussed on dermal reactions. While well run is not considered suitable to address this endpoint in isolation. Under the conditions of the study, in which a mean comedogenic grade of ≥ 2.0 in rabbits is considered to indicate potential comedogenesis in humans the test substance is not expected to be comedogenic in humans.
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