Registration Dossier

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:
2007-03-28 to 2007-04-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study performed according to OECD Guideline 405 (Acute Eye Irritation / Corr and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) without deviation.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Certificate issued by the Swiss GLP monitoring authorities

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study reports): T002675, TIC876
- Physical state: liquid
- Appearance: colorless to yellowish liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 603T-1
- Expiration date of the lot/batch: 2007-12-19
- Purity test date: no data
- Purity: 97.76%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was applied undiluted as it was delivered by the sponsor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 3 male and 3 female young adult New Zealand White Rabbits; Harland Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands; Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: 11-12 weeks for males; 11-13 weeks for females
- Weight at study initiation: 2082-2271 g
- Housing: standard laboratory conditions; individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 batch no.08/07 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch 01/07), ad libitum
- Water (e.g. ad libitum): Füllinsdorf community tap water, ad libitum
- Acclimation period: 5 days, under laboratory conditions after health examination. Only animals without any visual signs of illnes were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approximately 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled light cycle. Music was played during the daytime light period.

IN-LIFE DATES: From: 2007-04-02 To: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): test item was applied undiluted

Duration of treatment / exposure:
single application
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48, 72 hours, as well as 7 days after administration.
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed

SCORING SYSTEM:
- The eye reactions were assessed according to the numerical scoring system listed in the Commission Directive 2004/731EC, April 29, 2004. Scleral reddening and ocular discharge were also assessed.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
: redness
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
: redness
Basis:
animal #5
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
: redness
Basis:
animal #6
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: same score- all 3 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: same score- all 3 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritant / corrosive response data:
- No abnormal findings in the cornea or iris of any animal at any time.
- A slight to moderate reddening of the conjunctivae was noted in all animals 1 hour after instillation, and persisted up to 48 hours in the male and 72 hour in the females.
- Slight to moderate swelling of the conjunctivae was noted at the 1 hour observation that persisted to 24 hours.
- All animals had slight to moderate reddening of the sclera, 1-48 hours in the male, to 72 hours in the females, and slight to moderate discharge was present 1 to 24 hours after instillation in all animals.
- No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals.
Other effects:
VIABILITY/MORTALITY
- No clinical signs of systemic toxicity were observed, and no mortality occurred during the study.

COLORATION
- No staining of the treated eyes by the test item was observed.

CORROSION
- No corrosion of the cornea was noted at any of the observation times.

BODY WEIGHTS
- The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

Eye Irritation Scores - Individual Values

Animal Number

Sex

Evaluation Interval

Corneal Opacity

Area of Corneal Opacity

Iris

Conjunctivae

Sclera

Redness

Chemosis

4

M

1 hour

0

0

0

1

2

1

5

F

0

0

0

1

2

1

6

F

0

0

0

1

2

2

4

M

24 hours

0

0

0

1

1

1

5

F

0

0

0

2

1

2

6

F

0

0

0

1

1

2

4

M

48 hours

0

0

0

1

0

1

5

F

0

0

0

1

0

1

6

F

0

0

0

1

0

1

4

M

72 hours

0

0

0

0

0

0

5

F

0

0

0

1

0

1

6

F

0

0

0

1

0

1

4

M

7 days

0

0

0

0

0

0

5

F

0

0

0

0

0

0

6

F

0

0

0

0

0

0

* Examinations were performed at the specified times after instillation of the test item.

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the reffered classification(Commission Directive 2001/59/EC of August 06, 2001), T002675 is considered to be "not irritating" to the rabbit eye.