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Registration Dossier
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EC number: 800-696-3 | CAS number: 78605-96-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1993 to 11 January 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant GLP study conducted at reputable laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Heptanal, 2-(phenylmethylene)-, (2E)-
- EC Number:
- 800-696-3
- Cas Number:
- 78605-96-6
- Molecular formula:
- C14 H18 O
- IUPAC Name:
- Heptanal, 2-(phenylmethylene)-, (2E)-
- Details on test material:
- The test material typically contains >94% of the trans (E) isomer and 4-5% of the cis (Z) isomer.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd and/or Froxfield UK Ltd
- Age at study initiation: 13-17 weeks
- Weight at study initiation: 2.8 to 3.9 kg
- Housing: individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): adlibitum access to tap water
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70
- Air changes (per hr):19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 October 1993 To: 1 November 1993
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of undiluted amyl cinamic aldehyde instilled into one eye of each rabbit
- Duration of treatment / exposure:
- The eyelids were held together for one second following instillation to prevent immediate removal of test material. The eyes were not subsequently rinsed or flushed with water, saline or fluorescein.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- three
- Details on study design:
- The contralateral eye of each rabbit was left untreated as the control for comparative purposes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no reactions observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no reactions observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Slight conjunctival redness and swelling observed an hour after instillation in all three rabbits had largely resolved within 24 hours, very slight conjunctival redness remaining, and all reactions had overtly resolved by Day 2.
Any other information on results incl. tables
The mean scores for reactions over the 24 -72 hour post-instillation period were less than the EU classification thresholds for corneal, iridial and conjunctival responses.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Slight conjunctivitis was elicted by instillation of amyl cinnamic aldehyde into rabbit eyes. No corneal or iridial reactions were observed and the conjunctivae were overtly normal within 48 hours of treatment.
- Executive summary:
Instillation of amyl cinnamic aldehyde into the eyes of three rabbits according to standard test methods resulted in only slight transient conjunctival irritation and no corneal or iris reactions. The group mean scores were lower than the classification thresholds and amyl cinnamic aldehyde is therefore not considered for classification as an eye irritant according to CLP.
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