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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:
From September 22 to October 13, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted according to the original OECD Guideline 405 (1987).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(Adopted February 24, 1987)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 8α,-11-Oxido-13,14,15,16-tetranorlabdan / Ambroxan
- Physical state: white solid
- Stability under test conditions: stable for at least 2 years
- Storage condition of test material: cool and dark

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, D-Biberach
- Age at study initiation: approximately 20 months
- Weight at study initiation: approximately 2470 g
- Housing: individual accommodation
- Diet: Ssniff rabbit diet K4 ad libitum (Ssniff GmbH, D-Soest)
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 22, 1992 To: October 13, 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 75 hours after instillation, then on Days 7and 14.
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tepid tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scale as described in the OECD guideline No. 405.

TOOL USED TO ASSESS SCORE: slit lamp microscope

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, #2 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The observed conjunctival reactions of the experimental animals were weak and disappeared completely within 14 days.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time up to removal from the test

 

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0 / 0 / 0

0 / 0 / 0

1 / 1 / 2

1 / 1 / 1

0 / 1 / 0

24 h

0 / 0 / 0

0 / 0 / 0

1 / 1 / 1

1 / 0 / 0

0 / 0 / 0

48 h

0 / 0 / 0

0 / 0 / 0

1 / 1 / 1

0 / 0 / 0

0 / 0 / 0

72 h

0 / 0 / 0

0 / 0 / 0

1 / 1 / 1

0 / 0 / 0

0 / 0 / 0

Average 24h, 48h, 72h

0 / 0 / 0

0 / 0 / 0

1.0 / 1.0 / 1.0

0.33 / 0.0 / 0.0

0 / 0 / 0

Reversibility*)

-

-

c.

c.

-

Average time for reversion

-

-

14 days

48 h

-

*) 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 induced weak to mild irritation being reversible within 14 days. Therefore the test material is not classified as irritant to the eyes according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 3 Kleinrussen (Chbb: HM) rabbits. The eyes were rinsed 24 hours after the instillation of the test item. The left eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source, and then on Days 7 and 14. 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 observed conjunctival reactions of the experimental animals were weak and disappeared completely within 14 days. 

 

The individual score for each individual lesion for each animal within 3 scoring times (24, 48 and 72 hrs) were 1.00/1.00/1.00 for erythema, 0.33/0.00/0.00 for chemosis and 0.00 for discharge, iris lesions and corneal opacity.

 

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

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