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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
Based on the results the substance was considered as non-irritating to skin but corrosive to the eye (CLP).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1995-11-21 to 1995-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 92/67/EEC
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Y 01242250 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals:
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Age at study initiation: 3-5 mounths
- Weight at study initiation: 3.4-3.7 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/3 3 °C
- Humidity: 50-/- 20%
- Photoperiod: 12 hrs dark / 12 hrs light per day - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Remarks:
- (0.3 mL per animal)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster
REMOVAL OF TEST SUBSTANCE
- Washing : warm tap water
- Time after start of exposure: immedialely after the 4-hour exposure period
SCORING SYSTEM: Draize
Reading:
30-60 min as well as 24,48 and 72 hours after removal of the patches. Because of the persistent irritations in two animals 72 hours after removal of the patches, additional readings were performed after 7 days. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- 30-60 min up to 3 days after removal of the plasters two animals showed very slight to well defined erythema and very slight oedema. The third animal exhibited neither erythma nor edema. 7 days after removal of the patches all signs of irritation were reversible.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to read-across justification document attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Crotonic acid was tested in a primary skin irritation/corrosion study in the rabbit according to OECD guideline no. 404 and GLP (Hoechst AG, 1995). Three rabbits were exposed to 0.5 g of the test item dissolved in 0.5 mL isotonic saline, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations for erythema and edema were made 1, 24, 48 and 72 hours and 7 days after exposure and mean values for 24,48 and 72 hours were deduced according to the score of Draize. 30 -60 min up to 3 days after removal of the plasters two animals showed very slight to well defined erythema (score 2) and very slight oedema (score 1 and 0.7). The third animal exhibited neither erythema nor edema (score 0). 7 days after removal of the patches all signs of irritation were reversible. The study is reliable without restrictions.
In a skin irritation study (Hoechst AG (c), 1967) 5 rabbits were exposed to Crotonic acid by epicutaneous treatment once a day for five consecutive days. The test item concentrations were 1% and 10% in sesame oil. Animals treated with the highest test concentration showed redness, chapped and necrotic skin at the exposure area. 1% Crotonic acid induced minimal chapped skin at the exposure area by the end of the five day treatment period.
In an acute dermal toxicity study (Toxi-Coop Zrt.(b), 2012) 5 male and 5 female rats were exposed to 2000 mg/kg bw Crotonic acid by dermal route and left in contact with the skin for 24 hours. The observation period was 14 -days. 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.
Eye irritation
The eye irritation properties of Crotonic acid anhydride was examined in an OECD 405 and GLP compliant study (Hoechst AG, 1997). The study can be used for read across to Crotonic acid because the tested anhydride hydrolyses to Crotonic acid in the moist environment of the eye.
A New Zealand White rabbit was administered with 0.1 mL of the test item, applied to one eye of the rabbit while the other eye, remaining untreated, served as a control. The eyes were examined 1, 24, 48, 72 hours after administration of the test substance. Since effects were still present in the eye after 72 hours, further examinations were carried out after 7 and 14 days. One hour up to 14 days after administration the conjunctiva of the animal showed definitely injected blood vessels up to a diffuse beefy red color and an obvious swelling to a swelling with lids half closed to completely closed. 24 hours up to 14 days after administration the iris showed no reaction to light. Diffuse to opalescent areas of the cornea were observed one hour up to 14 days administration. Additionally, clear-colourless and white-yellow viscous discharge, exfoliation of the conjunctiva and nictating membrane as well as blanched nictitating membrane with hemorrhages were noted during the observation period. 14 days after administration the animal showed extreme vascularization. The study is reliable without restrictions.
In an eye irritation study (Hoechst AG (d), 1967) Crotonic acid (1% and 10% in sesame oil) was installed in the conjunctival sac of the eye of five rabbits and the animals were observed for 1, 3, 7 and 24 hours. Animals treated with the 10% solution showed slight redness, slight to district swelling of the conjunctiva and slight cornea opacity. 1% Crotonic acid induced no eye irritating effects. The reliability of the study is not assignable since only a short summary is available.
Justification for selection of skin irritation / corrosion
endpoint:
Most reliable study
Justification for selection of eye irritation endpoint:
Most reliable study
Effects on eye irritation: corrosive
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 skin and eye irritation, the
test item is classified and labelled as eye corrosive (H318: "Causes
serious eye damage") according
to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in
Regulation (EU) No 2017/776.
Classification regarding skin irritation is not warranted, according to Regulation (EC) No 1272/2008.
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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