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EC number: 945-910-7 | 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
Weight of Evidence: Substance Oral: LD50 = > 5000 mg/kg bw, 2017
Read-Across - methyl-2-[[(2,4-dimethyl-3-cyclohexen-1-yl)methylene]amino]benzoate: Oral: LD50= > 5000 mg/kg bw, female rat, eq. sim. to OECD TG 401, 1985
Read-Across - oxydipropanol: Oral: LD50= > 5000 mg/kg bw, female rat, US EPA OPP 81-1, 1995
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria are met.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have similar physico-chemical, toxicological properties and because of common breakdown products and therefore potential mechanisms of action. Specifically, this source substance is a constituent of the source and target. With no indications of adverse effects. The read-across is assessed as part of a weight of evidence approach. Further information is included in attachment to IUCLID section 13.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable composition. Further information is included in attachment to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
The source substance is source substance is a constituent of the source and target. The read-across in weight of evidence indicates despite a common potential mode-of-action between source and target, no adverse effects are seen in several studies. When the information is taken together by expert judgement the weight of evidence indicates that there is an absence of adverse effects associated with the target.
4. DATA MATRIX
Further information is included in attachment to IUCLID section 13.Further information is included in attachment to IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- 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: Recognised supplier
- Age at study initiation: males, 8 weeks of age; females, 10 weeks of age
- Weight at study initiation: males, 254 to 259 grams; females, 201 to 216 grams
- Fasting period before study: 18 hours, water was available at all times
- Housing: individually housed in wire cages under laboratory conditions.
- Diet (e.g. ad libitum): NIH-31M rodent diet, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 35-65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5010 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: First 5 hours post dose and then from 24 hours at twice daily intervals for 14 days
- Frequency of observations and weighing: All animals were examined shortly before and after dosing. On the day of dosing all animals were weighed and on day 15.
- Necropsy of survivors performed: Yes. Any animal found dead during the study would have undergone necropsy immediately. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality.
- Clinical signs:
- other: At one hour after dosing two males showed decreased locomotor activity and the remaninder of the group (3 male, 5 female) were ataxic. Similar signs persisted at three hours. At five hours following dosing several rats (4 male, 1 female) also showed yello
- Gross pathology:
- No significant findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the LD50 (male/female) was determined to be > 5000 mg/kg bw
- Executive summary:
The study was performed according to EPA OPPTS 870.1100 (Acute Oral Toxicity) in accordance with GLP to assess the acute oral toxicity potential of the test substance to Sprague Dawley male/female rats. Following an acclimatisation period and overnight fasting, the test material was administered as a single oral dose to a group of five male and five female rats by oral gavage at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment, after which they were subjected to gross necropsy. There was no significant effects observed during the study. All animals gained body weight. No abnormalities were observed during gross necropsy. Applicant assessment indicates that under the conditions of this study the LD50 male/female rats should be considered to be > 5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study follows protocols equivalent or similar to a recognised guideline and under GLP.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have similar physico-chemical, toxicological properties and because of common breakdown products and therefore potential mechanisms of action. The read-across is assessed as part of a weight of evidence approach. Further information is included in attachment to IUCLID section 13.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable composition. Further information is included in attachment to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
The source substance is a common degradant of the target substance and with common degradants to the target under physiological conditions. The read-across in weight of evidence indicates despite a common potential mode-of-action between source and target, no adverse effects are in studies. When the information is taken together by expert judgement the weight of evidence indicates that there is an absence of adverse effects associated with the target.
4. DATA MATRIX
Further information is included in attachment to IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- 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: Recognised Supplier
- Age at study initiation: Young adult (specific ages not reported).
- Weight at study initiation: males 239 - 257g; females 204 - 224g
- Fasting period before study: fasted overnight prior to dosing.
- Housing: Animals were housed in single sex groups of five in grid bottomed polypropylene cages.
- Diet: pelleted rodent diet ad libitum
- Water: mains drinking water ad libitum except during the pre-dose overnight.
- Acclimation period: at least 5 days (on receipt)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 49 - 58
- Photoperiod: 12 hours light / 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.25% aqueous gum tragacanth
- Details on oral exposure:
- Animals were dosed with the prepared test material by peroral injection using a rubber catheter attached to a syringe of suitable capacity. After dosing animals were returned to their cages and permitted access to food.
- Doses:
- The test material was suspended in 0.25% aqueous gum tragacanth to give a dose volume of 10 ml/kg at a dose level of 5.0 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: No effects observed due to treatment were reported in the study.
- Gross pathology:
- No significant effects or abnormalities observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the LD50 (male/female) was determined to be > 5000 mg/kg bw
- Executive summary:
The study was performed in a method equivalent or similar to OECD TG 401 under GLP to assess the acute oral toxicity potential of the test substance to Sprague Dawley male/female rats. Following an acclimatisation period and overnight fasting, the test material was administered as a single oral dose to a group of five male and five female rats, by peroral injection, at a dose level of 5000 mg/kg bodyweight at a dose volume of 10 ml/kg in 0.25% aqueous gum tragacanth vehicle. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment, after which they were subjected to gross necropsy. There was no significant effects observed during the study. All animals gained body weight. No abnormalities were observed during gross necropsy. Applicant assessment indicates that under the conditions of this study the LD50 male/female rats should be considered to be > 5000 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information as a whole meets the tonnage driven information requirements of REACH.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read-Across - methyl-2-[[(2,4-dimethyl-3-cyclohexen-1-yl)methylene]amino]benzoate: eq. similar to OECD TG 401 (1985): The study was performed in a method equivalent or similar to OECD TG 401 under GLP to assess the acute oral toxicity potential of the test substance to Sprague Dawley male/female rats. Following an acclimatisation period and overnight fasting, the test material was administered as a single oral dose to a group of five male and five female rats, by peroral injection, at a dose level of 5000 mg/kg bodyweight at a dose volume of 10 ml/kg in 0.25% aqueous gum tragacanth vehicle. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment, after which they were subjected to gross necropsy. There was no significant effects observed during the study. All animals gained body weight. No abnormalities were observed during gross necropsy. Applicant assessment indicates that under the conditions of this study the LD50 male/female rats should be considered to be > 5000 mg/kg bw.
Read-Across - oxydipropanol: US EPA OPP 81-1 (1995): The study was performed according to EPA OPPTS 870.1100 (Acute Oral Toxicity) in accordance with GLP to assess the acute oral toxicity potential of the test substance to Sprague Dawley male/female rats. Following an acclimatisation period and overnight fasting, the test material was administered as a single oral dose to a group of five male and five female rats by oral gavage at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment, after which they were subjected to gross necropsy. There was no significant effects observed during the study. All animals gained body weight. No abnormalities were observed during gross necropsy. Applicant assessment indicates that under the conditions of this study the LD50 male/female rats should be considered to be > 5000 mg/kg bw.
The applicant assesses this study by expert judgement and indicates that the weight of evidence by read-across to relevant data on both a common breakdown product (expected in physiological conditions) and/or main constituent that there is no evidence of significant toxicity at greater than acute oral toxicity: GHS category 4 levels. There is no evidence of significant clinical signs, body weight loss or abnormal signs in necropsy when tested at 5000 mg/kg bw limit dose in the male/female rat. The weight of evidence indicates that the substance should not produce significant acute toxicity as to produce are requirement to classify and label for acute oral toxicity in accordance with Regulation (EC) 1272/2008.
Justification for selection of acute toxicity – oral endpoint
Two in vivo studies available: 1. OECD 425: Klimisch 4 under GLP and; 2. eq. to OECD 401 under GLP: Klimisch 4 via read-across used within a weight of evidence approach to the endpoint.
Justification for classification or non-classification
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.
The substance does not meet classification criteria under Regulation (EC) No 1272/2008: for Specific Target Organ Toxicity - Single Exposure.
Evaluation of available in vivo studies only; the selected studies support the conclusion that the substance does not meet the criteria for STO – SE under Regulation (EC) 1272/2008. Necropsy did not indicate abnormalities at guidance levels. In all relevant studies body weight gains were observed. Clinical signs were transient and fully reversible and not supporting of any category of classification.
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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