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EC number: 203-533-9 | CAS number: 107-93-7
- 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: LD50: 2610 mg/kg bw for the rat
Inhalation: no effect observed
Dermal: LD50 > 2000 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:
- key study
- Study period:
- 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- body weight: 94-146 g
TEST ANIMALS
- Fasting period before study: yes - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- no data
- Doses:
- 1250; 2000; 2500; 3200; 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 610 mg/kg bw
- Mortality:
- yes, after 15-210 minutes
- Clinical signs:
- other: decedents: show imbalance and narcosis prior to death
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral toxicity (LD50) of crotonic acid in female wistar rats was determined to be 2610 mg/kg bw under the test conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 610 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1967
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: short summary, non GLP, no guideline followed
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 4 h whole body exposure to an unknown air concentration of the test substance.
- GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- Test type:
- standard acute method
- Species:
- other: rats (wistar) and guinea pig
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 28 L
- Method of conditioning air: 24.5 g of the product was vapoured at 125-130°C, Airflow: 500 liter/hour
- Temperature in air chamber: 29°C - Duration of exposure:
- 4 h
- Concentrations:
- less than 1.2 mg/L, exact concentration unknown (the evaporated test item recrystallised partly before the vapour reached the inhalation chamber)
- No. of animals per sex per dose:
- 5 rats and 5 guinea pigs
- Details on study design:
- - Duration of observation period following administration: 7 days
- Key result
- Sex:
- female
- Dose descriptor:
- LC0
- Effect level:
- > 0.9 - < 1.2 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: rats and guinea pigs were tested; actual exposure concentration unknown as the evaporated test item recrystallised partly before the vapour reached the inhalation chamber
- Mortality:
- no
- Clinical signs:
- other: no
- Body weight:
- no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the present acute toxicity study the inhalation of the test item crotonic acid showed no abnormal behaviour in rats and guinea pigs.
Reference
Based on the equation for saturated vapour concentrations it can be estimated that the concentration of the substance is approx. 0.88 mg/L saturated air at 20 °C. Therefore, it is assumed that at a temperature of 29 °C the test item concentration was between 0.88 and 1.2 mg/L.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 2012-08-22 to 2012-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DEBR 012553 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: 274-282 g (male), 239-265 g (female)
- Housing:animals were housed individually.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 47 days (females) and 5 days (males)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr):8-12 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 am. to 6 pm - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: approximately 10 % of the total body surface area
- Type of wrap if used: semi-occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing:using body temperature water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied:The test item was uniformly applied in a single dose to at least 10 % of the total body surface area
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- Pretest: 5, 50, 300 and 2000 mg/kg bw dose levels, Maintest: 2000 mg/kg bw
- No. of animals per sex per dose:
- Pretest: 2 female animals
Maintest: 5 female and 5 male animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: individually 1 h and 5 h after dosing, and once each day for 14 days
Body weight: shortly before treatment (pretest) and shortly before treatment, on day 7 and on day 15 (maintest)
- Other examinations performed: gross pathology - Preliminary study:
- There were no deaths in preliminary study at 5, 50, 300 and 2000 mg/kg bw dose levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema, wounds and crusts that was fully reversible at
- Gross pathology:
- No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present acute dermal toxicity study with the test item Crotonic acid, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
In an acute oral toxicity study (Hoechst AG (a), 1967) female wistar rats (10 per sex and dose) were treated with Crotonic acid in sesame oil in concentrations of 1250, 2000, 2500, 3200 and 5000 mg/kg bw. Animals were found dead after 15 -210 minutes and showed clinical signs like imbalance and narcosis prior to death. Under the conditions of the study a LD50 of 2610 mg/kg bw was deduced. The study was conducted under prior to implementation of GLP and test guidelines, but follows the principles of OECD guideline 401. It is classified as reliable with restrictions.
In an acute inhalation toxicity study (Hoechst AG (b), 1967) rats and guinea pigs were exposed to vapoured Crotonic acid for 4 hours followed by a 7 day observation period. Due to the partly recrystallisation of the test item on glass vessels before the vapour reached the inhalation chamber the concentration was not applicable. No death occured and no clinical signs were observed in rats and guinea pigs under the test conditions. Due to insufficient documentation the study is classified as not assignable.
An acute dermal toxicity study (Toxi-Coop Zrt. (b), 2012) was performed with the test item Crotonic acid in Crl:(WI)BR rats, in compliance with OECD Guideline No. 402 and OPPTS 870.1200. A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to Crotonic acid at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms that were fully reversible within the 14 -day observation period. As no necrosis was observed and the irritation symptoms were fully reversibel Crotonic acid was considered to be slighly irritating but not corrosive after a 24h exposure period. There was no test item related effect on body weight. No macroscopic alterations of organs and tissues related to the systemic toxic effect of the test item were seen during necropsy. In this acute dermal toxicity study with the test item Crotonic acid, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
Justification for selection of
acute toxicity – oral endpoint
Most reliable study
Justification for selection of acute toxicity – inhalation endpoint
Most reliable study
Justification for selection of acute toxicity – dermal endpoint
Most reliable study
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on acute toxicity, the
test item does not need to be classified according
to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in
Regulation (EU) No 2017/776.
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