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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 1999-05-10 to 1999-05-16
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:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
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 (incl. certificate)
Remarks:
UK GLP Compliance program (inspection date 1998-03-23)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Test material form:
liquid
Details on test material:
- Physical state: colourless liquid
- Storage condition of test material: room temperature in the dark under nitrogen

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.68 to 3.05 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum ((STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Contralateral eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The eye was not rinsed after the instillation of the test item.
Observation period (in vivo):
1, 24, 48 and 72 hours following instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: not applicable

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

TOOL USED TO ASSESS SCORE: animals were examined under a light source from a standard ophthalmoscope.

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
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis 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
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and persisted in one treated eye at the 24-hour observation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.
Other effects:
none

Any other information on results incl. tables

Table 7.3.2/1: Individual irritant/corrosive response data of the 3 animals at each observation time up to removal from the test

 

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0/0/0

0/0/0

0/0/0

1/1/1

1/0/1

1/1/1

24 h

0/0/0

0/0/0

0/0/0

1/0/0

0/0/0

0/0/0

48 h

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

72 h

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

Mean 24-48-72

0/0/0

0/0/0

0/0/0

0.33/0/0

0/0/0

0/0/0

Reversibility*)

-

-

-

c

c

c

Average time (unit) for reversion

-

-

-

48 h

24 h

24 h

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The individual score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hours ) were 0.00 for chemosis, discharge, iris and corneal lesions. A redness score of 0.33 was obtained in one animal, whereas the 2 others animals had scores of 0.00. Effects were fully reversible within 48 hours.
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 ST 08 C 98 was instilled into the right eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of ST 08 C 98. 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. 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. 

No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and persisted in one treated eye at the 24-hour observation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

 

 

The individual score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hours) were 0.00 for chemosis, discharge, iris and corneal lesions. A redness score of 0.33 was obtained in one animal, whereas the 2 others animals had scores of 0.00.

 

Under the test conditions, ST 08 C 98 is not classified as irritating to eyes according to 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.