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EC number: 202-790-4 | CAS number: 99-82-1
- 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
The oral LD50 in rats is >3000 mg/kg bw (Hüls 1989). The dermal LD50 in rats is > 2000 mg/kg bw (TC 2012).
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:
- 2/3 to 17/3 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to guideline study, non-GLP and no individual data reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Wilmslow Wistar
- Source: Harlan Winkelmann GmbH, 33167 Borchen
- Age at study initiation: young adults
- Weight at study initiation: average 153 g
- Fasting period before study: 16 hours before application
- Housing: 5 animals/macrolon III cage
- Diet: R10 allein diät Ssniff laboratory rat feed ad libitum
- Water: ad libitum
- Acclimation period: 5 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ±5%
- Air changes (per hr):15/hr
- Photo period (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 02-03-1989 To: 17-03-1989 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: NA
MAXIMUM DOSE VOLUME APPLIED: 3.75 cm³/kg bw - Doses:
- 3000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: until 6 hours and daily thereafter
Body weight:on day 0, 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: macrocopic investigations - Statistics:
- NA limit test
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: ventro-lateral recumbency, piloerection and diarrhea in males during first 24 hours.Thereafter, no observations.
- Gross pathology:
- thickening of the forestomach mucosa
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 in rats is >3000 mg/kg bw
- Executive summary:
In a limit test rats received 3000 mg/kg bw of the test substance. No mortality occurred. The LD50 is >3000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
- Quality of whole database:
- The LD50 is > 3000 mg/kg bw
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:
- 03-10-2012 to 18-10-2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to guideline under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Not indicated
- Weight at study initiation: Males 268 - 280 g; females 225 - 231 g
- Fasting period before study: NA
- Housing: 1/cage in Type II polypropylene/polycarbonate cages
- Diet: ssniff® SM R/M-Z+H complete diet ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 03-10-2012 To: 18-10-2012 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of body surface
- Type of wrap if used: semi occlusive gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with water
- Time after start of exposure: 24 hours
TEST MATERIAL: 2000 mg/kg bw - Duration of exposure:
- 24 hours with a 14 day observation period
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
mortality twice daily;
clinical signs at 1 and 5 hours after removal of the dressing, daily thereafter
body weight on day 1 (before treatment), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- NA limit test
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: local effects related to irritation (all reversible at day 7) : redness 3/5 males desquamation 1/5 males; 1/5 females crustiness: 2/5 males
- Gross pathology:
- hydrometra in 2/5 females
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for dermal toxicity is >2000 mg/kg bw
- Executive summary:
A single dose of the test substance at 2000 mg/kg bw was applied dermally to rats (5/sex). Signs of toxicity were limited to local irritant effects that were fully reversible after day 7. The LD50 for dermal toxicity is >2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The LD50 is > 2000 mg/kg bw
Additional information
No toxicity after acute oral and dermal exposure was observed.
Justification for selection of acute toxicity – oral endpoint
similar to guideline study, non-GLP and no individual data reported
Justification for selection of acute toxicity – dermal endpoint
study under GLP according to the guideline
Justification for classification or non-classification
The substance does not need to be classified for acute toxicity. Based on the viscosity data available (kinematic viscosity 1.107 mm²/s at 40°C) the substance needs to be classified as H304.
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