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EC number: 422-210-5 | CAS number: 68957-94-8 T3P
- 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 LD50 > 2000 mg/kg bw
dermal LD50 > 2000 mg/kg bw
Acute inhalation toxicity: Testing for acute toxicity via the inhalation route was not applicable as data on acute oral and acute dermal toxicity were available. According to REACH Regulation No. 1907/2006, Annex VIII, 8.5 data for a maximum of two routes of exposure need to be provided.
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:
- 1995-07-20 to 1995-08-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PPA 4/94
- Expiration date of the lot/batch: June 1996
- Purity test date: 1995-03-06
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness, room temperature, in a fume cupboard
- Stability under test conditions: stable
- Solubility and stability of the test substance in the vehicle: stable for 4 h
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the compound was administered as a 50 % solution in DMSO - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: males approx. 7 weeks, females approx. 8 weeks
- Weight at study initiation: 167 +/- 2 g (males) and 163 +/- 3 g (females)
- Fasting period before study: 16 h
- Housing: makrolon cages in fully air conditioned rooms, on soft wood granulate in groups of 5
- Diet: ad libitum ssniff R/M-H (V1534)
- Water: tap water ad libitum, plastic bottles
- Acclimation period: not anecessary as breeded at identical conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1995-07-20 To: 1995-08-03 - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 %
- Doses:
- one (limit) dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice daily, on weekends and holidays once. The animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopically visible changes - Statistics:
- no statisitical analysis performed as all findings were reversible
- Preliminary study:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: The following clinical signs were observed: reduced spontaneous activity, hunched posture, drawn in sides, pilo erection, high gait and unregular breathing. In the females additionally reduced palpebral fissure and uncoordinated gait observed. 2 days
- Gross pathology:
- Effects on organs:
The animals killed at the end of the observation period showed no macroscopically visible changes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test item was determined to be >2000 mg/kg bw.
- Executive summary:
To assess the acute oral toxicity of the test substance, a single (limit) dose of 2000 mg/kg bw was administered as a 50 % solution in DMSO to 5 male and 5 female Wistar rats via gavage. The study was conducted according to OECD Guideline 401 (1987). During the 14 days observation period clinical signs of toxicity and body weight changes were recorded. No deaths occurred during the study. The following clinical signs were observed: reduced spontaneous activity, hunched posture, drawn in sides, piloerection, high gait and unregular breathing. In the females additionally reduced palpebral fissure and uncoordinated gait observed. All effects were reversible within two days. At necropsy, no macroscopical changes were found. Based on the available data, the LD50 value of the test item was determined to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline-conform study
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:
- 1995-07-25 to 1995-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PPA 4/94 from September 1994
- Expiration date of the lot/batch: June 1996
- Purity test date: 1995-03-06
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness at room temperature in a fume cupboard
- Stability under test conditions: stable - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8-9 weeks
- Weight at study initiation: females: 194+/- 8 g, males: 223+/-6 g
- Housing: macrolon cages in fully air conditioned rooms
- Diet: ssniff' R/M-H (V1534) ad libitum
- Water: tap water ad libitum
- Acclimation period: none, breeding at same conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal skin, shaved and intact skin, about 30 cm2
- Type of wrap if used: aliminum foil and elastic plaster bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Duration of exposure:
- 24 h
- Doses:
- 2000 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 and weighing: symptoms were recorded twice daily, animals were weighed weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: none
- Gross pathology:
- no macroscopically visible changes
- Other findings:
- The treated skin area was partly brown-beige discoloured,
red, dry, rough, sore, incrusted and scally.
Additionally open wound, pink coloured new skin and scales were observed. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 value of the test item was determined to be > 2000 mg/kg bw.
- Executive summary:
To assess the acute dermal toxicity of the test substance, a single (limit) dose of 2000 mg/kg bw was administered undiluted to the shaved and intact dorsal skin of 5 male and 5 female Wistar rats. The study was conducted according to OECD Guideline 402 (1987). After the 24 h exposure the occlusive wrap was removed and the test sites washed. During the 14 days observation period no clinical signs of toxicity and body weight changes were recorded. No deaths occurred during the study. The following local effects were recorded: The treated skin area was partly brown-beige discoloured, red, dry, rough, sore, incrusted and scally. Additionally open wound, pink coloured new skin and scales were observed. At necropsy, no macroscopical changes were found. Based on the available data, the LD50 value of the test item was determined to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline-conform study
Additional information
To assess the acute oral toxicity of the test substance, a single (limit) dose of 2000 mg/kg bw was administered as a 50 % solution in DMSO to 5 male and 5 female Wistar rats via gavage. The study was conducted according to OECD Guideline 401 (1987). During the 14 days observation period clinical signs of toxicity and body weight changes were recorded. No deaths occurred during the study. The following clinical signs were observed: reduced spontaneous activity, hunched posture, drawn in sides, piloerection, high gait and unregular breathing. In the females additionally reduced palpebral fissure and uncoordinated gait observed. All effects were reversible within two days. At necropsy, no macroscopical changes were found. Based on the available data, the LD50 value of the test item was determined to be > 2000 mg/kg bw.
To assess the acute dermal toxicity of the test substance, a single (limit) dose of 2000 mg/kg bw was administered undiluted to the shaved and intact dorsal skin of 5 male and 5 female Wistar rats. The study was conducted according to OECD Guideline 402 (1987). After the 24 h exposure the occlusive wrap was removed and the test sites washed. During the 14 days observation period no clinical signs of toxicity and body weight changes were recorded. No deaths occurred during the study. The following local effects were recorded: The treated skin area was partly brown-beige discoloured, red, dry, rough, sore, incrusted and scally. Additionally open wound, pink coloured new skin and scales were observed. At necropsy, no macroscopical changes were found. Based on the available data, the LD50 value of the test item was determined to be > 2000 mg/kg bw.
Justification for classification or non-classification
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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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