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EC number: 818-033-1 | CAS number: 1629579-82-3
- 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
Acute toxicity: oral. 33Oxy.001
The Oral LD50 of the test substance was determined to be 3160 mg/kg bw in male and female rats. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.
Acute toxicity: oral. MA.002
The Oral LD50 of Maleic acid was determined to be 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.
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:
- weight of evidence
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Not GLP
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- minimum purity 95%
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: mean males: 182 g; mean females: 171 g
- Fasting period before study: 16 hours
- Housing: 5 animals per cage (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Concentration in vehicle: 14.7%, 21.5%, 31.6%
- Justification for choice of vehicle: aqueous preparation corresponds to physiological medium - Doses:
- 1470 mg/kg bw, 2150 mg/kg bw, 3160 mg/kg bw at 10mL/kg
- No. of animals per sex per dose:
- No. of animals per sex per dose: 5 Male and 5 Female animals per dose group.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: check for mortality twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 7 and 12
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 160 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality:
Dose (mg/kg) 3160 2150 1470
Males
Dead animals/total
animals after
1 h 0/5 0/5 0/5
1 d 4/5 0/5 0/5
2 d 4/5 0/5 0/5
7 d 4/5 0/5 0/5
14 d 4/5 0/5 0/5
Females
Dead animals/total
animals after
1 h 0/5 0/5 0/5
1 d 2/5 0/5 0/5
2 d 2/5 0/5 0/5
7 d 2/5 0/5 0/5
14d 2/5 0/5 0/5 - Clinical signs:
- other: Clinical signs included dyspnoea, rattling breath, apathy, agitation, abnormal position, staggering, tremble, tremor, spastic gait, piloerection, poor general state
- Gross pathology:
- - Animals that died: general congestive hyperemia; stomach: bloody gastritis in glandular stomach; intestine: atonic, reddened diarrheal content.
- Sacrificed animals: No abnormalities. - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The Oral LD50 = 3160 mg/kg bw.
- Executive summary:
The Oral LD50 of the test substance was determined to be 3160 mg/kg bw in male and female rats. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Charles river (CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - 0 grams - 222 grams (Mean weight: 202.7 grams) for female animal
- Fasting period before study: 18 to 20 hours
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rat Chow
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24
- Humidity (%): 40 to 60
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Concentration in vehicle: 40%
- Doses:
- 1900 mg/kg bw, 2700 mg/kg bw, 3800 mg/kg bw, 5300 mg/kg bw
- No. of animals per sex per dose:
- No. of animals per sex per dose: 5 Male and 5 Female animals per dose group.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At 1/4 hr, 1/2 hr, 1 hr, 2 hr and 4 hour timepoints following administration of compound, then daily thereafter for 14 days, Prefasting weights, fasting weights, and daily weights for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight, mortality - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 870 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 470 - < 3 250
- Mortality:
- 1900 mg/kg bw (0/5 Male and 2/5 Female),
2700 mg/kg bw (0/5 Male and 3/5 Female),
3800 mg/kg bw (4/5 Male and 5/5 Female),
5300 mg/kg bw (5/5 Male and 5/5 Female). - Clinical signs:
- other: Clinical signs observed were: decreased motor activity, coarse body tremors, blanching, salivation, pilo erection, and diarrhoea.
- Gross pathology:
- Soft stool (In 1 Male animal) / Diarrhea (In 1 Male and 1 Female animal) / Pale kidneys (In 3 Male animals) / liver (In 3 Male animals) / spleen (In 2 Male animals) /, Congested liver (In 2 Male animals) /, Bright/ moderate/deep red lungs (In 5 Male and 12 Female animals), Tan discoloration of lungs (In 1 Female animal), Petechiae on the lungs (In 2 Male and 2 Female animals), Compound/ fluid/ gas filled stomach/ intestine (In 9 Male and 15 Female animals), Nasal/ ocular hemorrhage (In 1 Male and 2 Female animals), Opaque left eye in 1 Male animal.
- Other findings:
- - Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The Oral LD50 = 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw.
- Executive summary:
The Oral LD50 of Maleic acid was determined to be 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- The read-across prediction was based upon the data available on the source substances. The two source substances Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine 4,7,10-Trioxatridecan-1,13-diam are mixed together in water in a 2:1 ratio to form the target substance. The only differences are the charged species and that the target substance only exists in an aqueous solution. The source and target substances are all mono-constituent substances. The molecular weight, number of hydrogen bond donors, number of hydrogen bond acceptors, water solubility, and partition coefficient values for both substances indicate they will have similar bioavailability in both an aquatic environment and after oral dosing.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 470 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4,7,10-Trioxatridecan-1,13-diamin
- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Impurities: 4,7-Dioxanonan-9-ol-1-amin
- Expiration date of the lot/batch: July 1985 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: mean males: 259 g; mean females: 218 g
- Housing: single housing (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ca. 50 cm² of shaved dorsal/dorsolateral skin
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2.15 mL/kg
- Concentration: undiluted - Duration of exposure:
- 24 hours
- Doses:
- 2150 mg/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: check for mortality/moribund animals twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 6 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: assessment of local effects (30 - 60 min after removal of semiocclusive coverage and afterwards at least once per week) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 150 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male animal died 2 days after application of the test substance.
- Clinical signs:
- other: Clinical signs included dyspnoea, apathy, aggressiveness, staggering, poor general state.
- Gross pathology:
- Animal that died: lungs: severe edema
Sacrificed animals: no abnormalities in organs observed - Other findings:
- Local skin effects: 1 male animal moderate, 1 male animal superficial erosions with crust formation; other animals: profound necrosis.
- Interpretation of results:
- other: slightly toxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.
- Executive summary:
Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The Test Substance was applied to the clipped intact trunk skin of four male New Zealand White rabbits per dose group and were retained in contact with the skin for 24 hours by an impervious plastic film. A 14-day observation period followed removal of the film.
- GLP compliance:
- no
- Test type:
- standard acute method
- Specific details on test material used for the study:
- No data
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Type of coverage:
- occlusive
- Duration of exposure:
- 24 hours
- Doses:
- No data
- No. of animals per sex per dose:
- 4 males
- Control animals:
- not specified
- Details on study design:
- Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5 - 3.5 kg. The fur was removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. The animals were immobilized during the 24-hour contact period, after which the film is removed, and the rabbits are caged for the subsequent 14-day observation period. The LD50 is estimated by the method of Thompson using the tables of Weil.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 525 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 151 - <= 5 535
- Remarks on result:
- other: calculated from original value 2.50 mL/kg bw using the density of 1.01 g/cm³
- Mortality:
- No data
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Interpretation of results:
- other: slightly toxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, the LD50 for acute dermal toxicity in New Zealand White (rabbit) has been determined to be 2525 mg/kg/bw.
- Executive summary:
Under the conditions of the study, the LD50 for acute dermal toxicity in New Zealand White (rabbit) has been determined to be 2525 mg/kg/bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Data from handbook or collection of data, read-across from maleic anhydride.
- Justification for type of information:
- Maleic anhydride hydrolyses under test conditions. As a result, it is believed that maleic acid and its salts were the test materials investigated in this study.
- Qualifier:
- no guideline followed
- Guideline:
- other: No data
- Principles of method if other than guideline:
- Test substance was applied as a 40% suspension in corn oil or a 40% aqueous solution with an exposure time of 24 hours and a 14 day exposure observation period. One animal per dose.
- GLP compliance:
- no
- Test type:
- other: No data
- Specific details on test material used for the study:
- - Constituent
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- other: corn oil or water
- Details on dermal exposure:
- Test substance was applied as a 40% suspension in corn oil or a 40% aqueous solution.
- Duration of exposure:
- 24 hours
- Doses:
- Suspension in corn oil: 631, 1000, 1580, and 2510 mg/kg
Aqueous solution: 251, 398, 631 and 1000 mg/kg - No. of animals per sex per dose:
- 1 (sex unknown)
- Control animals:
- not specified
- Details on study design:
- Observation period: 14 days
- Statistics:
- No data
- Sex:
- not specified
- Dose descriptor:
- LD100
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: test substance administered as 40 % suspension in corn oil
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- 631 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: test substance administered as 40 % suspension in corn oil
- Sex:
- not specified
- Dose descriptor:
- LD100
- Effect level:
- 631 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: test substance administered as 40 % aqueous solution
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- 398 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: test substance administered as 40 % aqueous solution
- Mortality:
- In the corn oil group, the rabbits survived at 631 mg/kg, but died within 1 day at 1000, 1580, and 2510 mg/kg.
In the aqueous group, the animals survived at 251 and 398 mg/kg, but died within 16 hours at 631 and 1000 mg/kg. - Clinical signs:
- other: Effects of both treatments produced reduced appetite and activity, increasing weakness, collapse and death.
- Gross pathology:
- No data
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Harmful; Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, according to the mortalities observed, the LD50 is higher than 398 mg/kg body weight and lower than or equal to 631 mg/kg body weight.
- Executive summary:
Maleic anhydride was administered at various dosed to groups of one rabbit each at doses between 251 and 2510 mg/kg body weight. The test substance was either suspended in corn oil (40 %) or dissolved in water (40 %). Maleic anhydride hydrolyses under test conditions. As a result it is believed that maleic acid and its sodium salt were the test materials investigated in this study.
In the corn oil group, the rabbit survived at 631 mg/kg, but died within 1 day at 1000, 1580, and 2510 mg/kg. In the aqueous group, the animals survived at 251 and 398 mg/kg, but died within 16 hours at 631 and 1000 mg/kg. Effects of both treatments produced reduced appetite and activity, increasing weakness, collapse and death. Gross pathological findings included lung and liver hyperemia, enlarged gallbladder, discoloration of the spleen and kidney, and gastrointestinal inflammation. In survivors, the viscera appeared normal.
The LD50, acute dermal rabbit is therefore estimated to be between 398 (practically: 400) and 1000 mg/kg body weight.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Maleic anhydride hydrolyses under test conditions. As a result, it is believed that maleic acid and its salts were the test materials investigated in this study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- other: Not stated
- Specific details on test material used for the study:
- - Constituent
- Maleic anhydride hydrolyses under test conditions. As a result it is believed that maleic acid and its sodium salt were the test materials investigated in this study. - Species:
- rabbit
- Strain:
- other: New Zealand
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- Three female New Zealand albino rabbits were used per dose and the doses were kept in place by gauze patches under a latex rubber film.
- Duration of exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- Three
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- No data
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 620 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No data
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- other: Relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test substance was relatively harmless when applied ermally to rabbits. The LD50 was >2000 mg per kg body weight.
- Executive summary:
Maleic anhydride was administered to the skin of female rabitts. Three animals were used per dose. Occlusive dressings were used.
The LD50 was 2620 mg per kg body weight. As maleic anhydride hydrolyses under test conditions, it is believed that maleic acid and its sodium salt were the test materials investigated in this study.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Data from handbook or collection of data, read-across from maleic anhydride.
- Justification for type of information:
- Maleic anhydride hydrolyses under test conditions. As a result, it is believed that maleic acid and its salts were the test materials investigated in this study.
- Guideline:
- other: No data
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- other: No data
- Specific details on test material used for the study:
- - Constituent
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- No data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 560 mg/kg bw
- Mortality:
- No data
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- other: Harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 derived from an acute dermal toxicity study with rabbits was 1560 mg/kg body weight.
- Executive summary:
The LD50 derived from an acute dermal toxicity study with rabbits was 1560 mg/kg body weight.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- The read-across prediction was based upon the data available on the source substances. The two source substances Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine 4,7,10-Trioxatridecan-1,13-diam are mixed together in water in a 2:1 ratio to form the target substance. The only differences are the charged species and that the target substance only exists in an aqueous solution. The source and target substances are all mono-constituent substances. The remaining source substance, Maleic Anhydride was used because this is the substance that can be found in the disseminated ECHA dossier for Maleic Acid, and that Maleic Anhydride hydrolyses under test conditions. As a result, it is believed that Maleic Acid and its salts were the test materials investigated in the studies.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
Referenceopen allclose all
Mortality:
Dose (mg/kg) |
2150 |
|
Males |
||
Dead animals/total animals after |
1 h |
0/5 |
1 d |
0/5 |
|
2 d |
1/5 |
|
7 d |
1/5 |
|
14 d |
1/5 |
|
Females |
||
Dead animals/total animals after |
1 h |
0/5 |
1 d |
0/5 |
|
2 d |
0/5 |
|
7 d |
0/5 |
|
14 d |
0/5 |
Mean body weights (g):
|
Dose (mg/kg) |
Weight day |
|||
0 |
2 |
6 |
13 |
||
Males |
2150 |
259 |
241 |
263 |
292 |
Females |
2150 |
218 |
241 |
211 |
231 |
Symptoms (cageside observations):
Dose (mg/kg) |
2150 |
Males |
|
Dyspnoea |
2D-5D |
Apathy |
2D-5D |
Agressiveness |
8D-9D |
Staggering |
2D-5D |
Poor general state |
2D-5D |
Females |
|
Dyspnoea |
2D-6D |
Apathy |
2D-5D |
Agressiveness |
6D-9D |
Staggering |
2D-6D |
Poor general state |
2D-6D |
D: Day
Local effects
Dose (mg/kg) |
2150 |
Males |
|
Profound necrosis |
1D-14D |
Edema |
1D-14D |
Females |
|
Profound necrosis |
1D-14D |
Edema |
1D-14D |
D: Day
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 150 mg/kg bw
Additional information
Acute Dermal
Acute toxicity: dermal. Maleic Acid_RA to Maleic Anhydride.001
Maleic anhydride was administered to the skin of female rabitts. 3 animals were used per dose. Occlusive dressings were used.
The LD50 was 2620 mg per kg body weight. As maleic anhydride hydrolyses under test conditions, it is believed that maleic acid and its sodium salt were the test materials investigated in this study.
Acute toxicity: dermal. Maleic Acid_RA to Maleic Anhydride.002
Under the conditions of the study, according to the mortalities observed, the LD50 is higher than 398 mg/kg body weight and lower than or equal to 631 mg/kg body weight.
Acute toxicity: dermal. Maleic Acid_RA to Maleic Anhydride.003
The LD50 derived from an acute dermal toxicity study with rabbits was 1560 mg/kg body weight.
Acute toxicity: dermal. 3,3oxy.002
Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.
Acute toxicity: dermal. 3,3oxy.003
Under the conditions of the study, the LD50 for acute dermal toxicity in New Zealand White (rabbit) has been determined to be 2525 mg/kg/bw.
Justification for classification or non-classification
Read across values from the most suitable substances have been used for classification.
The substance does not meet the criteria for classification for hazardous to the acute toxicity under CLP.
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