Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP; Study according to OECD-Guideline April 1981 lack of data on the purity / quality of the sample tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Additional observation and scoring of lacrimation
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Citrowanil B

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Five adulthealth albino rabbits (tattooed New Zealands) were used for the procedure, body weights between 2.8 and 3.3 kg.
The animals were housed in individual cages and were fed with a standard laboratory diet for rabbits (Altromin/Lage) (beside 16 hours before application) and were watered ad libitum.
The room temperature was kept constantly at 18 °C +/- 2 °C, the relative humidity 50 - 60 % and daily illumination time was 12 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml of the warmed undiluted substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
Duration of treatment / exposure:
The treated eye was not cleaned.
Observation period (in vivo):
7 days
Readings of eye alterations were made after 1, 2, 4, 8, 24 hours and 2, 3, 4, 5, 6, 7 days
Number of animals or in vitro replicates:
5
Details on study design:
For the test of the toxicity of materials to the eye mucosa serves the verification on noxious effects to cornea, iris, conjunctiva bulbi and palpebrae in the species rabbit according to the evvaluation code for eye lesions of Draize, 1958.
Before and after the test the eyes of all animals were examined with fluorescin 2 per cent under UV.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 and 2 hours
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: maximum single score: 1, only conjuctiva
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 4 hours
Score:
3.6
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: maximum single score: 1, only conjuctiva
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 8 hours
Score:
3.2
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: maximum single score: 1, only conjuctiva
Irritant / corrosive response data:
Only slight irritating effects (score 1) were observed in the conjunctivae (reddening, chemosis and lacrimation) till 8 hous after administration in all animals. 24 hours till 7 days after administration not any sign of irritation was observerd.
For details see Tables in "Any other information on results incl. tables".

Any other information on results incl. tables

Individual values of ocular lesions

Animal

 

 

hours

days

No.

 

 

1

2

4

8

24

2

3

4

5

6

7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

Cornea

A

0

0

0

0

0

0

0

0

0

0

0

 

 

B

0

0

0

0

0

0

0

0

0

0

0

 

Iris

A

0

0

0

0

0

0

0

0

0

0

0

 

Conjunctiva

A

1

1

1

1

0

0

0

0

0

0

0

 

 

B

1

1

0

0

0

0

0

0

0

0

0

 

 

C

1

1

1

1

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

Cornea

A

0

0

0

0

0

0

0

0

0

0

0

 

 

B

0

0

0

0

0

0

0

0

0

0

0

 

Iris

A

0

0

0

0

0

0

0

0

0

0

0

 

Conjunctiva

A

1

1

1

1

0

0

0

0

0

0

0

 

 

B

1

1

0

0

0

0

0

0

0

0

0

 

 

C

1

1

1

1

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

Cornea

A

0

0

0

0

0

0

0

0

0

0

0

 

 

B

0

0

0

0

0

0

0

0

0

0

0

 

Iris

A

0

0

0

0

0

0

0

0

0

0

0

 

Conjunctiva

A

1

1

1

1

0

0

0

0

0

0

0

 

 

B

1

1

0

0

0

0

0

0

0

0

0

 

 

C

1

1

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

Cornea

A

0

0

0

0

0

0

0

0

0

0

0

 

 

B

0

0

0

0

0

0

0

0

0

0

0

 

Iris

A

0

0

0

0

0

0

0

0

0

0

0

 

Conjunctiva

A

1

1

1

1

0

0

0

0

0

0

0

 

 

B

1

1

0

0

0

0

0

0

0

0

0

 

 

C

1

1

1

1

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

Cornea

A

0

0

0

0

0

0

0

0

0

0

0

 

 

B

0

0

0

0

0

0

0

0

0

0

0

 

Iris

A

0

0

0

0

0

0

0

0

0

0

0

 

Conjunctiva

A

1

1

1

1

0

0

0

0

0

0

0

 

 

B

1

1

0

0

0

0

0

0

0

0

0

 

 

C

1

1

1

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary of ocular lesions:

Animal

hours

days

No.

1

2

4

8

24

2

3

4

5

6

7

 

 

 

 

 

 

 

 

 

 

 

 

1

6

6

4

4

0

0

0

0

0

0

0

2

6

6

4

4

0

0

0

0

0

0

0

3

6

6

2

2

0

0

0

0

0

0

0

4

6

6

4

4

0

0

0

0

0

0

0

5

6

6

4

2

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

6.0

6.0

3.3

3.2

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The compound CITROWANIL B M 2/585 Nr. 4 can be classified as "non irritant" to eyes.
Executive summary:

The compound CITROWANIL B M 2/585 Nr. 4 was tested in a primary eye iritation test in rabbit eye. The substance was used undiluted.

Under the conditions of the experiment it was found:

Till 8 hours p.a. very slight conjuctival changes were observed.

The compound CITROWANIL B M 2/585 Nr. 4 can be classified as "non irritant" to eyes.

There is no objection for contact in the near of human eyes.