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Toxicological information

Eye irritation

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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:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material typically contains >94% of the trans (E) isomer and 4-5% of the cis (Z) isomer.

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:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: no reactions observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
2
Reversibility:
other: no reactions observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.44
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
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.