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EC number: 224-580-1 | CAS number: 4418-26-2
- 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
Oral:
The LD50 in the mouse was 1175 mg/kg bw.
The LD50 in the rat was > 1000 and <=2500 mg/kg bw.
The LD50 in the rabbit was >500 and <= 1000 mg/kg bw.
Dermal:
The LD50 in the rabbit was considered to be greater than 3000 mg/kg bw
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (only basic information given)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: Tylers Original
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 20 ± 2
- Fasting period before study: overnight
- Housing: in solid floor polycarbonate boxes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/mL solution - Doses:
- 500, 1000, 1500, 2000 and 2500 mg/kg bw (and also 5000 mg/kg bw in the preliminary study).
- No. of animals per sex per dose:
- 2 in preliminary study
10 in main study - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily - Preliminary study:
- A rangefinding trial was performed with 2 animals per dose (500, 1000, 2500 and 5000 mg/kg bw)
500 and 1000 mg/kg bw: no deaths occured
2500 mg/kg bw and more: all animals died on Day 1 - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 175 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 987 - <= 1 410
- Mortality:
- For details refer to Table 1 under "any other information on results".
- Clinical signs:
- other: 500 mg/kg bw and more: convulsions and stretching within 90 min of dosing, symptoms less severe in survivors after 48 h, asymptomatic after 72 h
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 = 1175 mg/kg bw.
- Executive summary:
The LD50 in the mouse was 1175 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- 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:
- (only basic information given)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- test performed using 2 animals only
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2000 ± 200 g
- Fasting period before study: overnight
- Housing: individually caged
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL solution - Doses:
- 500, 1000, 2500 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 500 - <= 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 500 mg/kg bw: 0/2
1000 mg/kg bw and more: 1/2 (24 h post-dose), 2/2 (at 48 h post-dose)
2500 mg/kg bw and more: 2/2 - Clinical signs:
- other: 500 mg/kg bw and more: disorientation and stretching within 120 min of dosing, survivors asymptomatic after 48 h
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 >500 and <= 1000 mg/kg bw.
- Executive summary:
The LD50 in the rabbit was >500 and <= 1000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (only basic information given)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- test performed using 2 animals only
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 ± 20 g
- Fasting period before study: overnight
- Housing: in grid-floor cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL solution - Doses:
- 500, 1000, 2500 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 500 and 1000 mg/kg bw: 0/2
2500 mg/kg bw and more: 2/2 (24 h post-dose) - Clinical signs:
- other: 500 mg/kg bw and more: trembling and convulsions within 120 min of dosing, survivors asymptomatic after 48 h
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 > 1000 and <=2500 mg/kg bw.
- Executive summary:
The LD50 in the rat was > 1000 and <=2500 mg/kg bw.
Referenceopen allclose all
Table 1 Acute oral toxicity: main study data for Day 14 only
Dose | Mortality on Day 14 |
[mg/kg bw] | |
N* | |
Males/Females | |
500 | 0/10 |
1000 | 6/10 |
1500 | 8/10 |
2000 | 9/10 |
2500 | 10/10 |
Table 2 Acute oral toxicity in the mouse: combined preliminary and main study data
Dose mg/kg bw | Mortality on Day 4 (No.) |
500 | 0/12 |
1000 | 6/12 |
1500 | 6/12 |
2000 | 8/10 |
2500 | 11/12 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Acute toxicity data are available for the oral and dermal routes. Examination of the life cycle of the substance indicates that human exposure is controlled by risk management measures in the inductrial and professional settings. It is therefore expected that inhalation exposure from the identified uses will be low. In addition, the most likely route of exposure for workers and consumers is the dermal route, where lack of systemic toxicity has been experimentally demonstrated. Consumers will only be exposed to low concentrations of the substance in solutions, where inhalation exposure is unlikely.
Reference
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:
- Reported in 1950
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method was described as essentially like that of Draize et al., (1944) J. Pharmacol. Exp. Therap. 82; 377. Cited in Principles and Methods of Toxicology, 5th Edition; ed. A. Wallace-Hayes, 2008.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Dehydroacetic acid.
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- occlusive
- Vehicle:
- other: Greaseless base - "Neobase".
- Details on dermal exposure:
- After application of the dosage, the site was occluded by bandages for 24 hours after which time they
were removed and the site washed with soap and water. - Duration of exposure:
- 24 hours
- Doses:
- 1000, 3000 or 5000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Sex:
- not specified
- Dose descriptor:
- approximate LD50
- Effect level:
- > 3 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One of the two rabbits treated at 5000 mg/kg bw died
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No rabbits died at 1000 or 3000 mg/kg bw. The LD50 was considered to be greater than 3000 mg/kg bw
- Executive summary:
Rabbits were treated dermally for 24 hours with dihydroacetic acid at dosages between 1000 and 5000 mg/kg bw. There were no deaths at 1000 or 3000 mg/kg bw. The LD50 was considered to be greater than 3000 mg/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
Additional information
Justification for classification or non-classification
Oral:
The LD50 in the mouse was 1175 mg/kg bw. : GHS Cat. 4
The LD50 in the rat was > 1000 and <=2500 mg/kg bw. : GHS Cat. 4
The LD50 in the rabbit was > 500 and <= 1000 mg/kg bw. : GHS Cat. 4
Dermal:
The LD50 in the rabbit was > 3000 mg/kg bw : GHS not classified
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