Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24April 2002
Deviations:
no
Qualifier:
according to
Guideline:
other: EC 440/2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 female New Zealand White rabbits from "Charles River Deutschland, 97633 Sulzfeld, Germany". Body weight at the beginning of the study: >2kg and age approximately 23-24 weeks old. The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art 9.2, No 7 of the German Act on Animal Welfare, the animals were bred for experimental purposes.

Housing and feeding conditions:
- Semi barrier in an air-conditioned room
- T: 18+/-3 degrees C.
- Relative Humidity: 55+/-10%
- Artificial light, sequence being 12 h light, 12 h dark
- Air change: min 10x /hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no 1325), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Housed in ABS - plastic rabbit cages, floor 4200m2
- Adequate acclimatisation period (at least 5 days)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 g
It was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for 1 second in order to prevent loss of material. The untreated eye served as control. The treated eyes were not rinsed within 24 hours after application.
Duration of treatment / exposure:
The lids were then gently held together for 1 second in order to prevent loss of material. The untreated eye served as control. The treated eyes were not rinsed within 24 hours after application.
Observation period (in vivo):
72 h after dosing
Number of animals or in vitro replicates:
3
Details on study design:
Initially one animal was tested. The test item was applied at a single dose of 0.1g in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for 1 second in order to prevent loss of material. The untreated eye served as control. The treated eyes were not rinsed within 24 hours after application.
If the results of the initial test do not indicate the test item to be corrosive or severe irritant to the eye, two additional animals will be tested for confirmation.
The animals were observed 72 hours after dosing.
The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored and recorded according to the grades on the tables below. For calculation, only the 24, 48 and 72-hour readings were used.
At the end of the observation period, the treated eyes were examined with the aid of a fluorescein solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h (average score)
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score: 1 until 24h, 0 later
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: "1, 24, 48, 72" (average score)
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48
Remarks on result:
other: Score: 2 at 1h, 1 at 24h and 0 later
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: "1h, 24h, 48h, 72h" (average score)
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Score of 1 until 48h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: "1h, 24h, 48h, 72h" average score
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Score: 2 at 1h, 1 at 24h and 0 later
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: "1h, 24h, 48h, 72h" (average score)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Score: 2 at 1h, 0 later
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: "1h, 24h, 48h, 72h" (average score)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Score: 1 at 1h, 0 later
Irritation parameter:
iris score
Basis:
mean
Time point:
other: "1h, 24h, 48h, 72h" (average score)
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: No effects
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: "1h, 24h, 48h, 72h" (average score)
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: No effects
Other effects:
Clinical signs of toxicity showed no systemic findings and only local findings (discharge grade 1) at time period 1h for all three animals.
No significant body weight changes occured during the observation period.

Any other information on results incl. tables

Additional info are presented in the attached study report

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for 1 second in order to prevent loss of material. The untreated eye served as control. The treated eyes were not rinsed within 24 hours after application.