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EC number: 915-650-9 | CAS number: -
- 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 toxicity, dermal in rats: LD50 > 2000 mg/kg bw (OECD 402, GLP, K, Rel.1)
Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent to OECD 401, K, Rel. 2)
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:
- Not reported
- 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 followed but not GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no details on test material (purity not indicated), no details on test animals and environmental conditions
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
No details.
ENVIRONMENTAL CONDITIONS
No details. - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No details.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 (no sex specified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data - Statistics:
- Not performed.
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- Slight lethargy was observed.
- Body weight:
- No data.
- 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 oral toxicity study with rats.
- Executive summary:
In an acute oral toxicity study one group of 10 rats was 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 deaths occurred and slight lethargy was observed among the animals.
Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute oral toxicity study with rats.
Reference
Dose mg/kg bw | No. of deaths | Observation day | |||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
5000 | 0/10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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:
- 17-31 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 402 without any deviation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- dated 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- dated 30 May 2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 23 October 2015
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS, France
- Females (if applicable) nulliparous and non-pregnant: Not precised
- Age at study initiation: 7 or 8 weeks
- Weight at study initiation: 249-264 g (males); 208-220 g (females)
- Housing: On Day 1 of the study, animals were housed by group of five in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. During the treatment, the animals were kept in individual cages.
- Diet (e.g. ad libitum): Foodstuff (SAFE - A04), ad libitum
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: At least 10/hour
- Photoperiod: 12 hours dark / 12 hours light - Type of coverage:
- other: Non-occlusive porous gauze
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area of the trunk (50 mm X 50 mm)
- % coverage: At least 10% of the body surface area
- Type of wrap if used: Animals from treated groups received the topical application of the test material under non occlusive porous gauze dressing (50 mm x 50 mm non-woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M).
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
- Washing (if done): After removal of the gauze dressings, the treated area was rinsed with distilled water.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.15 mL/kg bw (according to the density of 0.931 g/mL) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: historical control
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality were recorded at 1 hour, 3 hours, 5 hours, and then once daily for 14 days. Animals were weighed on Day D0 (just before administering the test item) and then on Day 2, Day 7, and Day 14.
- Necropsy of survivors performed: Yes; animals were euthanized with sodium pentobarbital on Day 14 and macroscopic observations were noted. - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6. Oedema was noted in maes at 24 hours post dose.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No systemic clinical signs related to the administration of the test substance were observed.
- Body weight:
- Body weight gain of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.
- Other findings:
- Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6.
Oedema was noted in maes at 24 hours post dose. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the dermal LD50 of the test substance is >2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008. No signal word or hazard statement is required.
- Executive summary:
In an acute dermal toxicity study performed according to the OECD Guideline 402 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was applied onto the intact skin of 5 male and 5 female Sprague Dawley rats under occlusive conditions for 24 hours. Animals were then observed for mortality, dermal reactions, body weight changes and clinical signs of toxicity for 14 days.
No mortality occurred during the study. No systemic clinical signs related to the administration of the test substance were observed. Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.
Rat Dermal LD50 >2000 mg/kg bw.
Under the test conditions, the dermal LD50 of the test substance is >2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008 . No signal word or hazard statement is required.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study conducted according to OECD TG 402
Additional information
Acute dermal toxicity:
In an acute dermal toxicity study performed according to the OECD Guideline 402 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was applied onto the intact skin of 5 male and 5 female Sprague Dawley rats under occlusive conditions for 24 hours. Animals were then observed for mortality, dermal reactions, body weight changes and clinical signs of toxicity for 14 days. No mortality occurred during the study. No systemic clinical signs related to the administration of the test substance were observed. Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6. Oedema was noted in males at 24 hours post dose. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes. Rat Dermal LD50 >2000 mg/kg bw.
Acute oral toxicity:
In an acute oral toxicity study one group of 10 rats was 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 deaths occurred and slight lethargy was observed among the animals.
Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute oral toxicity study with rats.
Justification for classification or non-classification
The oral and dermal LD50 are respectively higher than 5000 mg/kg bw and higher than 2000 mg/kg in rats, therefore the registered substance does not need to be classified for acute toxicity according to CLP Regulation (EC) n° 1272/2008.
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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