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EC number: 203-213-9 | CAS number: 104-55-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of test chemical on eye, when exposed by the ocular route in rabbits.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cinnamaldehyde
- EC Number:
- 203-213-9
- EC Name:
- Cinnamaldehyde
- Cas Number:
- 104-55-2
- Molecular formula:
- C9H8O
- IUPAC Name:
- 3-phenylacrylaldehyde
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report):Cinnamaldehyde
- Molecular formula :C9H8O
- Molecular weight :132.16 g/mol
- Substance type:Organic
- Physical state:Pale Yellow liquid
- Lot/batch No.:Lot 1/15
- Storage condition of test material:Stored in tightly closed container in refrigerator (below 4 degC).
- Other:
Handling and Disposal
Safety precautions : Aprons,masks, caps, gloves and goggles were used to ensure the health and safety of the personnel.
Disposal : The remaining unused test item was disposed as per internal SOPs of sa-FORD.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Procured from RABBI ROOF Animal Facility, A. P., India.
- Age at study initiation:4.0 to 4.5 Months (Approximately).
- Weight at study initiation:Minimum: 1.894 kg and Maximum: 2.074 kg (Prior to Treatment)
- Health Status :Healthy young adult. Females were nulliparous and non pregnant.
- Housing:The animals were housed individually in stainless steel cages.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed minimum twice a week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum.
- Acclimation period:Rabbits were acclimatised to the test conditions for a period of 7 days (Animal No.-1) and 14 days (Animal No. 2 and 3) prior to the application of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.20 °C and Maximum: 22.60 °C
- Humidity (%):Minimum: 42.00 % and Maximum: 74.70 %.
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml
- Concentration (if solution):N/A
VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- All the animals were observed at 1, 24, 48, 72 hours, day 7 and 14 after instillation of test item.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):The treated eye of rabbit was washed with normal saline.
- Time after start of exposure:24 hours
SCORING SYSTEM:Draize Method
TOOL USED TO ASSESS SCORE:Ophthalmoscope and sodium fluorescein strips.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24 hours after instillation of test item
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24 hours after instillation of test item
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24 hours after instillation of test item
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24 hours after instillation of test item
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 48 hours after instillation of test item
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 48 hours after instillation of test item
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 48 hours after instillation of test item
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 48 hours after instillation of test item
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 72 hours after instillation of test item
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 72 hours after instillation of test item
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 72 hours after instillation of test item
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 72 hours after instillation of test item
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 7
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 7
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 14
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 14
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 14
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: At day 14
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For treated eye
- Irritant / corrosive response data:
- In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 at till day 7observation which recovered at day 14.
Untreated eye of all the three rabbits was normal throughout the experimental period of 14 days.
The following grading scores were observed in treated eye of tested rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero in all 3 animals; Iris: Normal in all 3 animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was seen in all 3 animals; Chemosis: some swelling above normal (includes nictitating membranes) was seen in all animal.
Observation at 24 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero; Iris: Normal in all 3 animals; Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible in all animal; Chemosis: Obvious swelling with partial eversion of lids was seen in animal no. 1 whereas some swelling above normal (includes nictitating membranes) was seen in animal no. 2 and 3.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 70 %, 60 % and 60 % damage in animal no. 1, 2 and 3, resectively.
Observation at 48 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero; Iris: Normal in all 3 animals; Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible in all animal; Chemosis: Obvious swelling with partial eversion of lids was seen in animal no. 1 whereas some swelling above normal (includes nictitating membranes) was seen in animal no. 2 and 3.
Observation at 72 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero; Iris: Normal in all 3 animals; Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible in all the animals; Chemosis: some swelling above normal (includes nictitating membranes) was seen in all animals.
Observation at day 7 after instillation of test item revealed: Cornea- No ulceration or opacity was observed in animals number 1 and 3 whereas scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in animal number 2; Area of Opacity- No opacity was seen in animals 1 and 3 whereas one quarter (or less) but not zero was seen in animal number 2; Iris: Normal in all 3 animals. Conjunctivae: Diffuse, crimson color; individual vessels not easily discernible in all the animals; Chemosis: some swelling above normal (includes nictitating membranes) was seen in animal number 1 whereas swelling was recovered to normal in animals number 2 and 3.
Observation at day 14 after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- No opacity was seen in all 3 animals; Iris: Normal in all 3 animals. Conjunctivae: recovered to normal in all the animals; Chemosis: No swelling was observed in all the animals.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 1.00, 0.00, 2.00, 1.67; 1.00, 0.00, 2.00, 1.00 and 1.00, 0.00, 2.00,1.00, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
All the rabbits were observed with body weight gain on day 14 as compared to day 0.
Any other information on results incl. tables
Table 1 : Individual Animal Eye Irritation Scores
In Treated area Dose:0.1 ml of test item Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||||||||||||||||||||||||||||||
Application Side |
Right |
Right |
Right |
||||||||||||||||||||||||||||||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||||||||||||||||||||||||||||||
* |
1 |
24 |
48 |
72 |
Day 7 |
Day 14 |
* |
1 |
24 |
48 |
72 |
Day 7 |
Day 14 |
* |
1 |
24 |
48 |
72 |
Day 7 |
Day 14 |
|||||||||||||||||||||||
Corneal Opacity |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
||||||||||||||||||||||
Area of Opacity |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
||||||||||||||||||||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||||||||||||||||||||
Conjunctiva |
0 |
1 |
2 |
2 |
2 |
2 |
0 |
0 |
1 |
2 |
2 |
2 |
2 |
0 |
0 |
1 |
2 |
2 |
2 |
2 |
0 |
||||||||||||||||||||||
Chemosis |
0 |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
||||||||||||||||||||||
Corneal Damage% |
70 |
60 |
60 |
Dose:Untreated (Control Eye) Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||||||||
Application Side |
Left |
Left |
Left |
||||||||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||||||||
* |
1 |
24 |
48 |
72 |
Day 7 |
Day 14 |
* |
1 |
24 |
48 |
72 |
Day 7 |
Day 14 |
* |
1 |
24 |
48 |
72 |
Day 7 |
Day 14 |
|
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Corneal Damage% |
0 |
0 |
0 |
Key:*= Pre-exposure eye examination.
Table 1 (Continued):Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)
Animal No. Eye Reaction |
1 |
2 |
3 |
Corneal Opacity |
1.00 |
1.00 |
1.00 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
2.00 |
2.00 |
2.00 |
Chemosis |
1.67 |
1.00 |
1.00 |
Formula :
Mean Eye Irritation Score =
Sum of the Individual Animal Score for eye reactionat24, 48 and 72 hours
Number of the Observations (3)
Table 2: Individual AnimalClinicalSigns
Sex:Female
Animal No. |
Days (Post application observation) |
||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Table 3: Individual Animal Body Weight
Sex :Female
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
1.944 |
2.012 |
2 |
1.894 |
2.011 |
3 |
2.074 |
2.261 |
Key:kg = Kilogram
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of all 3 animals was observed at day 14.
Hence under the experimental test conditions,test chemical is “An Eye Irritant (Irritating to Eyes)” to New Zealand White Female rabbit eyes.Thus the test chemical is being classified as an eye irritant in 'Category 2' as per the CLP regulation. - Executive summary:
Acute eye irritation study was conducted to evaluate the eye irritant nature of the toxic chemical.
This study was performed as per OECD guideline no. 405. Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas; 0.1 ml of test item was instilled in the other (treated) eye of each rabbit.The eye was observed at 1, 24, 48, 72 hours, day 7 and 14 after test item instillation.Ophthalmoscope was used for scoring of eye lesions.In the initial test,0.1 ml of test itemwas applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed ocular lesions, hence confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 mlof test itemwas instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 1, 2 and 3 till day 7 observations which recovered at day 14.Untreated eye of all the three rabbits was normal throughout the experimental period of 14 days.
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of all 3 animals was observed at day 14.
Hence under the experimental test conditions,test chemical is “An Eye Irritant (Irritating to Eyes)” to New Zealand White Female rabbit eyes. Thus the test chemical is being classified as an eye irritant in 'category 2' as per the CLP regulation
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