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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:
12-MAY-2006 to 07-JUN_2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Description: Black powder
Stability of test item: Stable under storage conditions.
Storage conditions: At room temperature (range of 20 ±5 °C), in a exsiccator, light protected.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test system: Young Adult New Zealand White Rabbit, SPF
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 14 - 15 weeks (male) 14 - 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.

HUSBANDRY: Standard Laboratory Conditions: Air-conditioned with ranges for room temperature 17 - 23 °C, relative humidity 30 - 70% and approximately 10 - 15 air changes per hour. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 (batch no. 77/05) were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 85/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.Water: Community tap water from Füllinsdorf, ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
one second and the treated eyes were not rinsed after instillation.
Observation period (in vivo):
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
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.
The eyes of each animal were examined approximately 1, 24, 48, 72 hours as well as 7, 10, 14, 17 and 21 days after administration.
Number of animals or in vitro replicates:
3
Details on study design:
The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.

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
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: AFTER 24, 48 AND 72 HOURS
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number: 43
Time point:
other: AFTER 24, 48 AND 72 HOURS
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number: 44
Time point:
other: AFTER 24, 48 AND 72 HOURS
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 45
Time point:
other: AFTER 24, 48 AND 72 HOURS
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: AFTER 24, 48 AND 72 HOURS
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight corneal opacity affecting the whole area was observed in all animals 1 hour after treatment. No abnormal findings were observed in the iris of any animal at any of the measurement intervals.
Moderate reddening of the conjunctivae was noted in all animals at the 1- hour reading and persisted as slight reddening in two animals till 48 hours after application and in one animal until 72 hours after application.
No swelling (Chemosis) of the conjunctivae was observed.
Slight to moderate reddening of the sclerae was noted in all animals at the 1-hour reading and persisted in two animals till the 48- and in one animal till the 24-hour reading.
Slight ocular discharge was noted in all animals at the 1-hour reading.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
Slight to marked black staining of the treated eyes produced by the test item was observed in all animals throughout the whole observation period. Black remnants of the test item were observable in the three rabbits from 1 hour to 72 hours after application.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article is irritant to the eye of rabbits (Stains the eyes ).
Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 0.67 and 0.67 for reddening and 0.00 for chemosis for all three animals, respectively.

The instillation of test item into the eye resulted in mild and early-onset ocular changes, such as corneal opacity, reddening of the conjunctivae and sclerae and discharge. Slight to marked black staining of the treated eyes was noted in all animals at the 1-hour reading and persisted as slight staining in all animals until the 21-day reading, the end of the observation period for all animals. Black remnants were observed in the eye or conjunctival sac of all the rabbits from 1 hour to 72 hours after application. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No clinical signs were observed.