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EC number: 205-465-5 | CAS number: 141-17-3
- 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
Endpoint summary
Administrative data
Description of key information
Oral (similar to OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rabbit: LD50 > 5000 mg/kg bw (limit test)
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:
- 21 Oct 1996 - 4 Nov 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
- 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: Ace Animals, Inc., Boyertown, PA, USA- Age at study initiation: approximately 6 - 9 weeks- Weight at study initiation: 222 - 254 g- Fasting period before study: 18 hours- Housing: stainless steel, indirect bedding- Diet: Lab Diet Certified Rodent Diet #5002, ad libitum- Water: ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 21 Oct 1996 - 4 Nov 1996
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- After 18 hours of fasting and prior to dosing, all rats (5 male: 5 female) were weighed and marked with ear clips. The weight variations of animals did not exceed ±20%. Individual doses were administered on the basis of body weight using a stainless steel intragastric feeding needle. Volumes of dose were 1.1 to 1.2 mL in all cases.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: animals were observed at 1, 3, 6 and 24 hours and daily thereafter for a total of 14 days.- Frequency of observations and weighing: at least once daily- Necropsy of survivors performed: complete gross necropsy performed on animals sacrificed at the end of the 14-day observation period. Sacrifice was accomplished via carbon dioxide asphyxiation.- Other examinations performed: animals were observed for signs of pharmacological activity and drug toxicity
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- A single male rat died by the 24 hour observation period.
- Clinical signs:
- other: Depression was noted in the single male animal that died. Slight depression was recorded in a single other male rat but this resolved by the 24 hour observation period. All other male rats appeared normal.Slight depression was noted in 3/5 female rats but
- Gross pathology:
- In 3 female rats, a red discharge was noted around the nose. The small intestines appeared moderately reddened. The stomachs appeared ulcerated.
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.
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:
- 25 Oct 2012 - 19 Dec 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study. No signature.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- xxx_DRAFT REPORT_XXX
- 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: Charles River, Sulzfeld, Germany
- Age at study initiation: males: 8 - 9 weeks; females: 12 - 14 weeks
- Weight at study initiation: males: 231 - 250 g; females: 208 - 234 g
- Housing: individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 160812)
- Diet: Altromin 1324 maintenance diet for rats and mice (lot no. 1039), ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: not less than 10%
- Type of wrap if used: The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using aqua ad injectionem (Ampuva, lot no. 19FG30HA, expiry date: 06/2015)
- Time after start of exposure: 24 h
TEST MATERIAL
The test item was used as delivered by the sponsor. - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of dosing (once during the first 30 minutes and with special attention given during the first 4 hours post-dose) and once daily until the end of the observation period thereafter
- Frequency of weighing: on day 1 (prior to the application) and on days 8 and 15
- Necropsy of survivors performed: yes (in case of findings during gross pathological examination, the tissues were preserved for a possible histopathological evaluation)
- Other examinations performed: Primary Skin Irritation using the Draize Scoring System - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred throughout the study period.
- Clinical signs:
- other: No signs of systemic toxicity were observed throughout the study period. Signs of dermal irritation after a single dose application were noted in females only: scratches (2/5) on Days 7-11; desquamation (1/5) on Days 7-11; eschar (1/5) on Days 9-11. Howev
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Additional information
Acute toxicity: via oral route
The available key study (Nitka, 1997) was conducted according to the EPA OTS 798.1175 test guideline (simillar to OECD 401) and in compliance with GLP (limit test). Five Wistar rats per sex received the undiluted test item by oral gavage at the limit dose of 5000 mg/kg bw. A single male rat died during the 14-day observation period and showed depression before death. Slight depression was recorded in a single other male rat, but this resolved by the 24 hour observation period. All other male rats appeared normal. Slight depression was noted in 3/5 females, which resolved within 24 h post dosing. Red anal and urethral discharges were noted, with peri-anal hair loss, which was resolved in all animals by observation day 13. Body weight gain was as expected in all animals. Based on these results, the oral LD50 was determined to be >5000 mg/kg bw for both male and female rats.
Acute toxicity: via inhalation route
No data available (exposure based waiving).
Acute toxicity: via dermal route
The available key study (Schmid, 2013) was conducted according to the OECD 402 and in compliance with GLP (limit test). The shaved dorsal skin of 5 Wistar rats per sex was exposed to the undiluted test substance at a limit dose of 5000 mg/kg bw for 24 h under semiocclusive conditions. After removal of the test substance, animals were observed for a period of 14 days. No mortality and no clinical signs of toxicity were observed up to the end of the observation period. Signs of slight dermal irritation were noted in females only, including scratches (2/5), desquamation (1/5) and eschar (1/5). The body weight development of all male and female animals was within the expected range. Necropsy revealed no substance-related findings. Based on these results, the dermal LD50 was determined to be >5000 mg/kg bw for both male and female rats.
Justification for selection of acute toxicity – oral endpoint
The key study was selected for assessment.
Justification for selection of acute toxicity – dermal endpoint
The key study was selected for assessment.
Justification for classification or non-classification
The available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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.
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