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EC number: 230-989-6 | CAS number: 7394-38-9
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 29 October 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Data generated according to internationally accepted testing guideline performed according to GLP, but further details on the test item are lacking in the report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Sprague-Dawley Crl:CD® (SD) IGS BR rat
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.
The test material was administered orally undiluted. - Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.
The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- No signs of sytemic toxicity
- Body weight:
- Female: weekly increase of 19 to 32 g
Male: weekly increase from 32 to 68 g - Gross pathology:
- No abnormalities detected
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was estimated as being greater than 2500 mg/kg bodyweight.
The test item is therefore not classificated with acute oral toxicity according to the CLP regulation 1272/2008/EC. - Executive summary:
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley Crl:CD® (SD) IGS BR rat (SPL Standard Test Method 512.07). The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method Bl tris Acute Oral Toxicity (Oral - Acute Toxic Class Method).
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.
The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths or signs of systemic toxicity noted during the study.
The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was estimated as being greater than 2500 mg/kg bodyweight. The test item is therefore not classificated with acute oral toxicity according to the CLP regulation 1272/2008/EC.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 14 October 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study can be used to draw a conclusion on the non corrosive/ non-irritating properties to skin of the tested substance. The report consists of a summary of the conducted study including detailed raw data without detailed information on the procedure followed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
VEHICLE
- not required - Duration of treatment / exposure:
- 4 hour
- Observation period:
- 1, 24, 48 and 72 hours after administration
- Number of animals:
- 3
- Details on study design:
- TEST SITE
the test material was administered to the intact skin
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after administration.
SCORING SYSTEM:
- Method of calculation: prinmary irritation index, according to Draize (1959) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- To evaluate the classification of the substances according to CLP Regulation, the raw data were reinterpreted.
The mean value from gradings at 24, 48 and 72 hours after patch removal calculated in at least 2 of 3
tested animals were the following:
- erythema/eschar: score 0/6=0 (3 out of 3 animals)
- oedema: 0/6=0 (3 out of 3 animals) - Other effects:
- None reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results allows clear decision that the substance p-Nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) is not corrosive and not irritating to skin according to the regulation 1272/2008/EC after reinterpretation of the raw data.
- Executive summary:
A study was performed to assess the irritation potential of the test material p-Nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.06). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal lrritation/Corrosion" and Method 84 of Commission Directive 92l69lEEC (which constitutes Annex V of Council Directive 67l54SlEEC).
The results may be used as a basis for classification and labelling according to the Regulation 1272/2008/EC after reinterpretation of the raw data.
A single 4-hour semi-occluded application (0.5 ml) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
The mean value from gradings at 24, 48 and 72 hours after patch removal calculated were the following:
- erythema/eschar: score 0/6=0 (3 out of 3 animals)
- oedema: 0/6=0 (3 out of 3 animals)
No evidence of skin irritation/corrosion was noted. The test material is not corrosive and not irritant to skin according to the regulation 1272/2008/EC.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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