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EC number: 935-783-6 | CAS number: -
- 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
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study which was stated to be according to OECD guideline 402. However, only males were tested at the limit dose of 2000 mg/kg bw while females were tested at 1000 mg/kg bw.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- yes
- Remarks:
- In males the limit dose of 2000 mg/kg bw was tested. Females were tested with 1000 mg/kg bw. Either females should have been tested at the limit dose as well or a complete study design should have been performed to be in compliance with OECD 402.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2009-02-09, North Rhine-westphalia
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Preventol KMX
- IUPAC Name:
- Preventol KMX
- Details on test material:
- - Name of test material (as cited in study report): Preventol KMX (confirmation of the identity of the test item was performed)
- Physical state: Colorless liquid
- Analytical purity: 100%
- Lot/batch No.: CHK 2109
- Expiration date of the lot/batch: 2011-09-21
- Storage condition of test material: At room temperature due to product information by the sponsor
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar HsdCpb:Wu
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, 5960 AD Horts, Netherlands
- Age at study initiation: approx. 9 - 13 weeks (assumed by the body weight)
- Weight at study initiation: 290 g - 300 g (males), 203 - 213 g (females)
- Housing: individually
- Diet: Provimi Kliba 3883 PM S15 Maus/Ratte Haltung, Kaiseraugust Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 5%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm^2 on the hair free back (approx. 10% of body surface)
- % coverage: 100%, (semiocclusive)
REMOVAL OF TEST SUBSTANCE
- Washing: The dressings were removed and the test site was rinsed with tepid water using soap and gently patting the area dry.
- Time after start of exposure: After 24 hours
TEST MATERIAL
- Amounts applied: The amount of applied pure test substance was calculated on basis of the actual body weight.
- Constant volume: No - Duration of exposure:
- 24 hours
- Doses:
- 1000 mg/kg bw (female)
2000 mg/kg bw (males) - No. of animals per sex per dose:
- 5 males at 2000 mg/kg bw (dose range 19.3 - 20.0 mg/cm^2)
5 females at 1000 mg/kg bw (dose range 6.8 - 7.1 mg/cm^2) - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 22 days
- Frequency of observations and weighing: Clinical signs and mortality were determined several times at the day of application (defined as day 1) and at least once daily thereafter. The weight gain was checked weekly.
Animals which died or were sacrificed in a moribund state were weighed and subjected to gross pathology
- Necropsy of survivors performed: yes - Statistics:
- A validated LAN-linked computer system was used for data collection, processing and evaluation.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: top dose used in females
- Mortality:
- 1/5 males died during the observation period.
No death occured in females. - Clinical signs:
- Clinical signs at 1000 mg/kg bw (females) and 2000 mg/kg (males) bw comprised of: decreased motility, bloody urine, narrowed palpebral fissure and piloerection.
Local signs at site of application at 2000 mg/kg bw (males) were: dark discoloration, thickening, a partial induration, swelling, encrustation and formation of scale skin.
Local signs at site of application at 1000 mg/kg bw (females) were: dark discoloration, thickening, a partial induration, encrustation and formation of scale skin.
For details see table 1 in section "Any other information on results" - Body weight:
- The body weight and the body weight gain were decreased on day 8 of the study in males and females. For details see Table 2 in section "Any other information on results"
- Gross pathology:
- Gross pathology of the males which died during the observation period revealed dilated intestine (gas filled) and brownish-black discolored kidneys.The males and females sacrificed at study termination showed a partial formation of scale on the site of application.
Any other information on results incl. tables
Table 1: Incidence and duration of clinical signs
Parameter |
Incidence |
Duration of parameter |
Males |
||
decreased motility |
5/5 |
2 h – 2 d |
bloody urine |
5/5 |
2 h – 7 h |
narrowed palpebral fissure |
5/5 |
3 h – 2 d |
piloerection |
1/5 |
2 d |
Local effects |
|
|
partial induration |
4/5 |
2 d – 7 d |
swelling |
4/5 |
2 d |
dark discoloration |
3/5 |
2 d – 8 d |
thickening |
4/5 |
3 d – 7 d |
scale skin |
4/5 |
7 d – 22 d |
encrustation |
4/5 |
8 d – 21 d |
Females |
||
decreased motility |
5/5 |
40 min – 2 d |
bloody urine |
5/5 |
40 min – 5 h |
narrowed palpebral fissure |
5/5 |
2 h – 5 h |
piloerection |
5/5 |
2 h – 2 d |
Local effects |
|
|
partial induration |
5/5 |
3 d – 10 d |
dark discoloration |
5/5 |
2 d – 10 d |
thickening |
5/5 |
2 d |
scale skin |
5/5 |
11 d – 22 d |
encrustation |
5/5 |
3 d – 20 d |
Table 2: Body weight and body weight gain
Day |
1 |
8 |
15 |
22 |
Males |
||||
Mean body weight (g±SD) |
296± 3.9 |
287± 6.5 |
327± 7.7 |
351± 6.2 |
Mean body weight gain (g±SD) |
- |
- 8± 6.7 |
41± 6.1 |
24± 2.3 |
Females |
|
|
|
|
Mean body weight (g±SD) |
207± 3.7 |
203± 3.6 |
215± 5.4 |
235± 9.2 |
Mean body weight gain (g±SD) |
- |
- 4± 1.2 |
12± 5.2 |
20± 10.6 |
SD = Standard deviation
Table 3: Table for acute dermal toxicity
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
1/5/5 |
2 h – 22 d |
2d |
20 |
Females |
||||
1000 |
0/5/5 |
40 min – 22 d |
--- |
0 |
LD50 males >2000 mg/kg bw LD50 females >1000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: acute dermal Cat 4, H312
DSD: Xn, R21
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