Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9th November to 19th November 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in compliance with: • OECD guideline No. 405, 24th April 2002, • EC Directive No. 2004/73/EEC, B.5, 29th April 2004.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Beige powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Number: three animals were used, as recommended by the international guidelines.
Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body
weight ± standard deviation of 2.8 ± 0.2 kg.
Acclimation: at least 5 days before the beginning of the study.
Identification: individual metal ear tag.

The conditions in the animal room were set as follows:
• temperature: 18 ± 3°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular
intervals.
The animals were housed individually in Techniplast cages (64 cmx 63 cm x 30 cm).
Each cage was equipped with a food container and a water bottle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100mg
Duration of treatment / exposure:
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
The study was ended on day 4 in the absence of persistent ocular reactions.
Observation period (in vivo):
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
The study was ended on day 4 in the absence of persistent ocular reactions.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
0.7
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
not specified

Any other information on results incl. tables

Very slight to moderate conjunctival reactions including a very slight or a slight chemosis (grade 1 or 2), a slight or a moderate redness of the conjunctiva (grade 1 or 2) and a clear discharge, were observed in all animals from day 1; some of these reactions persisted up to day 2 (1 animal) or 3 (2 animals). No other ocular reactions were observed during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test item is slightly irritant when administered by ocular route to rabbits. However according to the
classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and
administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item should not be classified as
irritating to the eyes.
Executive summary:

Under the experimental conditions, the test item is slightly irritant when administered by ocular route to rabbits. However according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item should not be classified as irritating to the eyes