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EC number: 248-777-7 | CAS number: 28015-99-8
- 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
Acute oral toxicity
Five rats/sex received a dose of ca. 2500 mg/kg bw of the test substance (PSL 1981). Two females died on day 1. Other animals survived until the end of the 14 day observation period. No effects on body weight, clinical signs and macroscopic findings were reported except in the deceased animals. The LD50 of the testsubstance is > 2500 mg/kg bw.
Studies on the analogues DNNSA and BaDNNSA showed LD50 values of > 2000 mg/kg bw and 1750 mg/kg bw respectively
Acute inhalation toxicity
Rats (5/sex) were exposed to the test substance at 2.6 mg/L by inhalation (PSL 1981). No mortality, clinical signs or effects on body weight were observed. It is therefore concluded that the LC50 is >2.6 mg/L. Analytical information on the actual concentration in the test chamber is not provided.
Acute dermal toxicity
The test substance did not induce mortality in an acute dermal toxicity study (PSL 1980). As part of the animals had an abraded skin, this represents a worst case situation. It is therefore concluded that the test substance is of low acute toxicity.
Studies on formulations of the analogues DNNSA and BaDNNSA showed LD50 values of > 1000 mg/kg bw (as active ingredient).
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:
- December 2 - 26, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited report, non GLP. Sufficient to allow a conclusion on the LD50 value. The information in the report is limited to the information in the summary.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA, CFR Title 21, para. 191.1.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- 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: Taconic Farms
- Age at study initiation: not reported
- Weight at study initiation: Males: 212-290 g; Females: 200-234 g
- Fasting period before study: 18 hours prior to dosing
- Housing: individually
- Diet: Fisher Rat Chow ad libitum
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- in 3/10 animals
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
MAXIMUM DOSE VOLUME APPLIED: 5.0 mL - Doses:
- 2500 mg/kg bw (calculated from dosing volume)
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated (weighing at start and end of study reported)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Mortality:
- 2 of 5 females died on day 1
- Clinical signs:
- none reported
- Body weight:
- within expected ranges (except in deceased animals)
- Gross pathology:
- Pulmonary Hemorrhage; Bloated Gastro-Intestinal Tract in decendents
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the testsubstance is > 2500 mg/kg bw
- Executive summary:
Five rats/sex received a dose of ca. 2500 mg/kg bw of the test substance. Two females died on day 1. Other animals survived until the end of the 14 day observation period. No effects on body weight, clinical signs and macroscopic findings were reported except in the deceased animals. The LD50 of the testsubstance is > 2500 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- No information on the actual concentration tested is 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:
- December 4 - 17, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited reported test, non GLP. The information in the report is limited to the information in the summary.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA 16 CFR 1500
- Principles of method if other than guideline:
- 5 animals/sex, 3 males and 2 females with skin abrasions
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Cedar Knolls Farm
- Age at study initiation: not reported
- Weight at study initiation: Males: 2.6-3.3 kg; Females: 2.7-3.1 kg
- Fasting period before study: NA
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 4-5 cm2
- Type of wrap if used: elastic sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
TEST MATERIAL
- Amount(s) applied: 2 g/kg bw
- Concentration (if solution): 50% - Duration of exposure:
- 24 hours
- Doses:
- 1000 mg/kg bw (calculated from dosing )
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated (weighing at start and end of the study)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs - Statistics:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- none
- Clinical signs:
- none reported
- Body weight:
- within expected ranges
- Gross pathology:
- not performed
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The LD50 of the test substance is > 1000 mg/kg bw. The substance does not need to be classified for acute dermal toxicity in view of he absence of any effects, even when applied on abraded skin (worst case)
- Executive summary:
The test substance was applied on the skin of rabbits for 24 hours at 2000 mg/kg bw (as formulation of 50%). No mortality, clinical effects and effects on body weight were observed. Therefore it is concluded that the acute toxicity of the test substance is low. The LD50 is > 1000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 1 000 mg/kg bw
Additional information
The available studies contain sufficient information to be used for risk assessment and classification and labelling. All tests are performed on a 50% formulation. The effect levels are based on active ingredient, as it is not expected that the diluent has contributed to the effects if any.
Justification for selection of acute toxicity – oral endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two animals died and no further adverse effects were observed.
Justification for selection of acute toxicity – dermal endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two animals died and no further adverse effects were observed.
Justification for classification or non-classification
Based on the available studies (all indicative of low toxicity), it is concluded that the test substance does not need to be classified. The dermal LD50 of the test substance could warrant classification, but in a weight of evidence approach based on the worst case situation (abraded skin) and absence of any effects in the test with the test substance as well as based on the read-across to the acid, classification is considered not necessary.
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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