Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1989-02-10 to 1989-02-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 405 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

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
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical state: pale yellow liquid or white solid
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: M: 15 weeks; F: 16 weeks
- Weight at study initiation: M: 2.7 kg; F: 2.6-2.9 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 42/88 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Itingen ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From:1989-02-10 To: 1989-02-21

Test system

Vehicle:
other: undiluted or in Neantine
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Left eye: 0.1 g (undiluted) / Right eye: 0.1 mL (diluted into 30 % in Neantine)
Duration of treatment / exposure:
Eyes were not rinsed
Observation period (in vivo):
Eyes were observed 1, 24, 48, 72 hours and 7 days after administration
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure:

SCORING SYSTEM: Draize scale according to the OECD test guideline No. 405

TOOL USED TO ASSESS SCORE: slit-lamp and diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
See Table 7.3.2/1
Other effects:
none

Any other information on results incl. tables

Table 7.3.2/1: Mean irritant/corrosive response data of each animal at each observation time up to removal from the test

 

Score at time point / Reversibility

Cornea opacity(/4)

Iris

(/2)

Conjunctivae

Redness

(/3)

Chemosis

(/4)

1 h

0/0/0

0/0/0

2/2/2

1/0/1

24 h

0/0/0

0/0/0

1/1/2

0/0/1

48 h

0/0/0

0/0/0

0/0/2

0/0/1

72 h

0/0/0

0/0/0

0/0/1

0/0/0

Mean 24-48-72 hrs

0.0/0.0/0.0

0.0/0.0/0.0

0.33/0.33/1.67

0.00/0.00/0.67

Reversibility*)

-

-

c.

c.

Average time (unit) for reversion

 

 

7 days

72 hours

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of undiluted Fixambrene was instilled into the left eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The left eye of each rabbit was instilled with 0.1 mL Fixambrene diluted at 30 % in Neantine. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. 

 

The calculated mean score for each individual lesion for each animal treated with undiluted Fixambrene within 3 scoring times (24, 48 and 72 h) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions.

The effects observed were all reversible within 7 days.

 

Under the test conditions, Fixambrene is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.