Registration Dossier
Registration Dossier
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EC number: 242-016-2 | CAS number: 18127-01-0
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not provided
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA standards
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Bourgeonal
- IUPAC Name:
- Bourgeonal
- Reference substance name:
- 3-(4-tert-butylphenyl)propionaldehyde
- EC Number:
- 242-016-2
- EC Name:
- 3-(4-tert-butylphenyl)propionaldehyde
- Cas Number:
- 18127-01-0
- Molecular formula:
- C13H18O
- IUPAC Name:
- 3-(4-tert-butylphenyl)propanal
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Bourgeonal
- Substance type: clear colourless liquid
- Physical state: Liquid
- Lot/batch No.: 148983
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by an accredited supplier.
- Age at study initiation:
Adult
- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.5 - 3.0 kg
- Housing:
Not specified in the report
- Diet (e.g. ad libitum):
Not specified in the report
- Water (e.g. ad libitum):
Not specified in the report
- Acclimation period:
Not specified in the report
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not specified in the report
- Humidity (%):
Not specified in the report
- Air changes (per hr):
Not specified in the report
- Photoperiod (hrs dark / hrs light):
Not specified in the report
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: EXAMPLE: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
A volume of 0.2 ml .
- Concentration (if solution):
Undiluted and used as supplied
VEHICLE
- Amount(s) applied (volume or weight with unit):
Not applicable
- Concentration (if solution):
Not applicable
- Lot/batch no. (if required):
Not applicable
- Purity:
Not reported- Duration of treatment / exposure:
72 hours- Observation period (in vivo):
Approximately 24, 48 and 72 hours and 7 days following treatment- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not applicable
- Time after start of exposure:
Not applicable
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The ocular effects of bourgeonal generally consisted of slight redness and swelling of the conjunctivae.
After seven days these lesions had cleared up only partially. - Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Pure and undiluted bourgeonal caused slight eye irritation and according to the FDA-standards it is not considered to be an eye irritant.
- Executive summary:
Pure and undiluted Bourgeonal caused slight eye irritation and according to the FDA-standards it is not considered to be an eye irritant.
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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