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EC number: 258-751-7 | CAS number: 53767-93-4
- 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
Acute oral toxicity: OECD TG 401: LD50 >5000 mg/kg bw
Acute dermal toxicity: OECD TG 402: LD50 >5000 mg/kg bw
Acute inhalation (route to route extrapolation): no adverse effect predicted
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been follo wed but not GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Study pre-OECD guidance. However, the dosing and observations at this time are similar to the OECD 401 test guidance.
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- other: oral
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/Kg Body weight
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- other: none
- Interpretation of results:
- other: Not acute harmful.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- An LD50 of >5000 mg/kg bw was calculated in the acute oral toxicity study with rats.
- Executive summary:
In an acute oral toxicity study a group of 10 rats were orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured and no clinical signs were observed.
Based on the results, an LD50 of >5000 mg/kg bw was calculated in the acute oral toxicity study with rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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 October 1979 - 30 October 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- No data on environmental conditions.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: TacN (SD) fBR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms (Germantown, N.Y.)
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: males: 200 - 237g; females: 182 - 207g
- Fasting period before study: no
- Housing: The animals were housed singly in wire cages.
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
No data. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Range finding test: Two rats of each sex were used per dose. Each animal received a single dose of the test substance. Rats were observed for the next 72 hours to determine the mortality. In other respects the test system was similar to that described below. The doses were 50, 160, 500, 1600 or 5000 mg/kg bw.
TEST SITE
Experimental procedure:
On the day prior to treatment, the backs of the rats were clipped from the scapular region to the hips using an Angra clipper blade. Before application, a non-lubricated condom with the closed end cut off was slipped over the tail and hind legs, and it was adjusted to cover the trunk between the shoulder girdle and the hips. The test substance was applied evenly over the back using a B-D disposable syringe and a 14G gavage needle.
- Type of wrap if used: 2 inch elastic adhesive bandage (Elastikon)
REMOVAL OF TEST SUBSTANCE
- Washing: None, the excess material was removed by wiping with a dry cloth.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 5.75 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: Yes, all the animals underwent a gross necropsy at the end of the experiment. The animals were killed using ether.
- Preliminary study:
- In a preliminary assay two rats of each sex were treated by application of the test substance to the skin at 50, 160, 500, 1600 or 5000 mg/kg bw. There were no deaths during the 72 hour observation period.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the s
- Gross pathology:
- There were no signs indicative of toxicity in any of the 12 animails necropsied at termination.
- Interpretation of results:
- other: Not acute harmful.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- An LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.
- Executive summary:
In an acute dermal toxicity study a group of 12 rats (6 males and 6 females) were dermally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured. The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the study.
Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute dermal toxicity result is of sufficient quality and adequate for this dossier.
Additional information
Acute oral (Key study):
In an acute oral toxicity study a group of 10 rats were orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured and no clinical signs were observed. Based on the results, an LD50 of >5000 mg/kg bw was calculated in the acute oral toxicity study with rats.
Supporting study: In another study with limited information an LD50 > 10 mL per kg body weight was found (record not included).
Acute inhalation
Acute inhalation: Acute inhalation is predicted based on the acute oral toxicity in accordance with the ECHA CLP guidance document (2015, 3.1.3.3.4: 1 mg/kg bw = 0.0052 mg/l (5.2 mg/m3).
The acute inhalation is predicted to be:
LC50=5000 x 5.2 x 50/100 = 13000 mg/m3 (using 100% inhalation and 50% oral absorption).
The calculated saturated vapour pressure is 1563 mg/m3 (MW*VP/ 8.3 (gas constant)*293oK). This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation is anticipated.
Acute dermal
In an acute dermal toxicity study a group of 12 rats (6 males and 6 females) were dermally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured. The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the study. Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.
Justification for classification or non-classification
The substance does not need to be classified for acute oral, dermal and inhalation toxicity according to EU CLP (EC No. 1272/2008 and its amendments).
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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