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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 09, 2007 - May 22, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conform with Directive 2004/73/EC, B.5, OECD Guideline No. 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
Test system: Young Adult New Zealamd White Rabbit, SPF
Rationale: Recongnized by the international guidelines as the recommended test system.
Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands Postbus 6174, NL-5960 AD
Horst / The Netherlands
See information below "Details on test animals"

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Species / Strain: Young Adult New Zealamd White Rabbit, SPF
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 12 weeks (male), 15 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Allocation: Male No. 64, Female Nos. 65, 66
Housing: Individual in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum.
- Water (e.g. ad libitum): Community tap water

ENVIRONMENTAL CONDITIONS
Temperature (°C): 17-23°C (Air-conditioned)
Humidity (%): 30-70% , 10-15 air changes per hour
Photoperiod: 12 hours light and 12 hours dark
Music was played during the daytime light period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
0.1 g (per animal) of AES was weighed and applied undiluted as it was delivered by the sponsor.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days.
Number of animals or in vitro replicates:
3 (Animals of both sexes were used).
Details on study design:
TREATMENT:
The eyes of the animals were examined one day prior to test item administration.
On the day of treatment, 0.1 g of AES was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from
the eyeball. The lids were then gently held together for about one second to prevent loss of test item.
The treated eyes were not rinsed after instillation.
OBSERVATIONS:
Viability/Mortality / Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
EYE OBSERVATION TIME POINTS AND TERMINATION:
The eyes of each animal were examined approximately 1, 24, 48, 72 hours , as well as 7 days after administration.
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).
NECROPSY:
No necropsy was performed on the animals sacrificed at termination of observation.
The animals were killed by intravenous injection of Pentobarbitone into the ear vein at a dose of at least 1 mL/kg body weight and discarded.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: After 24, 48 and 72 hours
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after instillation
Score:
0 - 0.33
Max. score:
1
Reversibility:
fully reversible
Remarks:
no longer evident 7 days after treatment
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after instillation
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
No abnormal findings were observed on the treated eye of any animal 7 days after treatment, the end of the observation time.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining of the treated eyes produced by the test item was observed.
The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Base upon the referred classification criteria (commission Directive 2001/59/EC of August 2001), AES is considered to be "Not Irritation" to rabbit
eye.
Executive summary:

The mean score was calculated across 3 scoring times for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for the conjunctivae were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 0.33 and 0.00 for reddening, respectively and 0.00 for chemosis for each of the three animals.

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