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Diss Factsheets
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EC number: 252-744-2 | CAS number: 35836-73-8
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral in rats: LD50 = 890 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel. 2)
Acute toxicity, dermal in rabbits: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 402, non-GLP, 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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted similarly to OECD Guideline 401 with deviations: purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not weighed after dosing; gross pathology not reported
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not; gross pathology not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 340, 670, 1310, 2560 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 /dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination. - Statistics:
- None
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 890 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Deaths occurred at day 13 (1 animal) and 14 (2 animals) following administration of test item at the dose of 670 mg/kg bw, and overnight (4 animals), Day 1 (2 animals) and Day 2 (1 animal) following administration of test item at 1310 mg/kg bw
- Mortality:
- - Deaths occurred overnight to 14 days following administration of test item.
- 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively. - Clinical signs:
- other: diarrhea at 670 mg/kg, lethargy and flaccid rats at 1310 mg/kg, and lethargy, diarrhea and flaccid rats at 5000 mg/kg were observed
- Gross pathology:
- - No data
- Other findings:
- None
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw by oral route in the rat.
According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required. - Executive summary:
In an acute oral toxicity study performed similarly to Guideline OECD 401, groups (10 /dose) of rats were given a single oral dose of Nopol at 340, 670, 1310, 2560 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.
Diarrhea, lethargy and flaccid rats were observed. Deaths occurred overnight to 14 days following administration of the test item. 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.
In this study, the oral LD50 of the test item was 890 mg/kg bw.
The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw.
According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 890 mg/kg bw
- Quality of whole database:
- acute oral toxicity study performed similarly to OECD Guideline 401
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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted similarly to OECD Guideline 402 with deviations: purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- purity of test item not reported; duration of exposure, source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Doses:
- 2500 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 2 animals at 2500 mg/kg and 8 at 5000 mg/kg
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 3 days
- Necropsy of survivors performed: Yes; gross necropsy was performed on all animals at the termination of the study. - Statistics:
- None
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: One rabbit died on Day 2 and one on day 3, out of 8 animals
- Mortality:
- One rabbit died on Day 2 and one on Day 3
- Clinical signs:
- other: Slight redness at 5000 mg/kg in one rat and moderate redness and edema in others, ataxia, ptosis and piloerection were observed.
- Gross pathology:
- Liver mottled, lungs dark and area of exposure very red and edematous in one animal.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.
- Executive summary:
In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.
Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw. The dermal LD50 of the test item was considered to be higher than 5000 mg/kg bw in rabbits.
The acute dermal LD50 of Nopol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- acute dermal toxicity study performed similarly to OECD Guideline 402
Additional information
Acute oral toxicity:
In an acute oral toxicity study performed similarly to Guideline OECD 401, groups (10 /dose) of rats were given a single oral dose of Nopol at 340, 670, 1310, 2560 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.
Diarrhea, lethargy and flaccid rats were observed. Deaths occurred overnight to 14 days following administration of the test item. 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.
The oral LD50 for Nopol was evaluated to 890 mg/kg mg/kg bw in rats wich is higher than 300 mg/kg body weight and lower than 2000 mg/kg by oral route in the rat.
Acute dermal toxicity:
In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.
Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw.
The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits.
Justification for classification or non-classification
Acute oral toxicity:
The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw by oral route in the rat.
According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.
Acute dermal toxicity:
The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP regulation EC No. 1272/2008 and GHS.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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