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EC number: 600-299-3 | CAS number: 102322-83-8
- 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 (OECD 423), rat: LD50 cut-off value = 500 mg/kg bw
Dermal (OECD 402), rat: LD50 > 5000 mg/kg bw
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:
- 5 Apr - 6 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 172.8 - 195.7 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mech cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 23.1
- Humidity (%): 45.1 - 54.5
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance 2000 mg/kg bw was selected as the starting dose. - Doses:
- 2000 mg/kg bw (step 1)
300 mg/kg bw (step 2 and 3) - No. of animals per sex per dose:
- 6 (300 mg/kg bw); 3 (2000 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14. The body weights of animals found dead during the observation period were recorded prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: Histopathological examination was performed on animals with gross findings in the thoracic cavity, stomach and/or liver at 2000 mg/kg bw. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- All animals dosed at 2000 mg/kg were found dead on Days 1, 2 and 3 after dosing, respectively.
No mortality was observed at 300 mg/kg bw. - Clinical signs:
- Salivation and/or lacrimation were observed in two animals at 2000 mg/kg bw from 0.5 and 1 h after dosing. Abnormal gait, salivation, staining around mouth, decrease in locomotor activity, decrease of fecal volume and/or lacrimation were observed on Days 1, 2 and 3 after dosing. Three animals were found dead in a state of lying on side, dorsal position, prone position or staining around mouth on Days 1, 2 and 3 after dosing, respectively. These clinical signs were considered to be test substance-related.
During the observation period, no clinical abnormalities were observed in any animal at 300 mg/kg bw. - Body weight:
- A tendency to suppressed body weight gain was observed in two animals at 2000 mg/kg bw on Day 1. These changes were considered to be test substance-related.
Normal body weight gains were observed in all animals at 300 mg/kg bw. - Gross pathology:
- Macroscopic examination of dead animals revealed gross findings in the thoracic cavity, stomach and/or liver.
No grossly visible evidence of morphological abnormalities was observed in any animal at 300 mg/kg bw. - Other findings:
- - Histopathology: Histopathological examination of the liver revealed granular and eosinophilic hepatocellular degeneration, single cell necrosis of hepatocytes and perivenular mononuclear cell infiltration. These findings showed centrilobular distribution. In the forestomach, epithelial necrosis with submucosal hemorrhage and edema were observed. The hepatic and gastric findings were considered to be associated with gross findings in the liver and forestomach, respectively. These necropsy findings were considered to be test substance-related.
- Interpretation of results:
- other: Acute Tox. Cat. 4
- Remarks:
- according to Regulation (EC) 1272/2008
- Conclusions:
- In this acute oral toxicity study in rats a LD50 cut-off value of 500 mg/kg bw was found.
- Executive summary:
Three animals dosed at 2000 mg/kg died on Days 1, 2 and 3 after dosing.
There were no deaths of any of the six animals at 300 mg/kg. No test substance-related effects were observed in clinical signs, body weight data or necropsy findings in any animal at 300 mg/kg.
Based on the result of the acute oral toxicity study in Sprague-Dawley rats the test item was classified to be Category 4
The LD50 cut-off is 500 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
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:
- 11 - 25 Nov 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No information on purity was given and reduced number of test animals per sex.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no data on purity of test substance, only 2 animals per sex instead of 5 animals per sex
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 10-12 weeks
- Weight at study initiation: 228-293 g (males), 197-234 g (females)
- Housing: individually during the 24 h exposure period and subsequently up to 4 animals of the same sex per cage in polypropylene cages, bedding sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 45-65
- Air changes (per hr): approx. 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: skin of the dorsal, lateral and ventral regions (6 cm x 12 cm)
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze patch (7 cm x 4 cm) which was held in place with a strip of elastic adhesive bandage (7.5 cm wide and 25-30 cm long) wrapped around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amounts applied: 0.06, 0.47, 2.33 and 5.82 mL/kg bw
- Constant concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 50, 400, 2000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
Frequency of observations and weighing: Animals were observed 1 and 4 h after administration and subsequently once daily for 14 days. Mortality and evidence of overt toxicity was recorded at each observation. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- No clinical signs of toxicity were noted during the 14-day observation period.
- Body weight:
- All treated animals showed normal bodyweight gains during the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was found.
- Executive summary:
An acute dermal toxicity study in rats was performed according to OECD 402 with 50, 400, 2000 and 5000 mg/kg bw of the test substance with 2 animals per sex and dose. No mortality was observed and the animals showed no signs of toxicity. Due to these results it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2). This study is not a standard information requirement set out in Annex VII of Regulation (EC) No 1907/2006 and is thus considered as additional information.
Additional information
Oral
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2016). In this acute oral toxicity study in rats a LD50 cut-off value of 500 mg/kg bw was found.
Dermal
The acute dermal toxicity of the test substance was assessed in a study according to OECD Guideline 402 and in compliance with GLP (1985). In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was found.
Justification for classification or non-classification
The available data on acute oral toxicity of the test substance meet the criteria for Acute Tox. Cat. 4 (H302) according to Regulation (EC) 1272/2008.
The available data on acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, 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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