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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 7th April 1992 to 21st April 1992
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:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Compliance Programme (inspected on 1990-06-19/signed on 1990-10-05

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): ST 02 C 88
- Substance type: pure active substance
- Physical state: colourless liquid
- Lot/batch No.: A/D/33906 (Toxicol reference N°)
- Storage condition of test material: ca. 4°C under nitrogen in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, U.K.
- Age at study initiation: not provided in the study report
- Weight at study initiation: Rabbit 1: 2.4 kg, rabbit 2: 3.0 kg, rabbit 3: 3.5 kg
- Housing: individually housed in grid bottomed metalcages.
- Diet (e.g. ad libitum): ad libitum (SQC standard· rabbit pellets produced by Special Diets Services, witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C
- Humidity (%): 41-59%
- Air changes (per hr): not mentionned in the study report (air conditioned room)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye (left eye)
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):
Examination made 1, 24, 48 and 72 hours following instillation. An additional examination was conducted on the last 2 animals to be dosed, 7 days after dosing, in order to assess the reversibility of the response.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): N.A.
- Time after start of exposure: N.A.

SCORING SYSTEM: Draize scale according to the OECD guideline No. 405
See "Any other information on material and methods incl. tables"

TOOL USED TO ASSESS SCORE: standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal: # 1, #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: #1 & #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal: #1 & #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
One hour after dosing, conjunctival hyperaemia was noted in the treated eye of all 3 rabbits. In 2 animals this was accompanied by conjunctival chemosis and discharge from the treated eye. Twenty-four hours after dosing, discharge was no longer apparent in any animal but hyperaemia and chemosis were noted in all 3 rabbits. Forty-eight hours after dosing, hyperaemia, at a reduced level, was still apparent in all 3 animals whilst conjunctival chemosis was noted in only one rabbit. Seventy-two hours after dosing, the treated eye of 2 animals appeared to be free of all signs of irritation. Observations on the first rabbit, used in the preliminary screen, were discontinued at this time. Slight conjunctival hyperaemia persisted in the treated eye of one animal. Seven days after dosing, the treated eye of this rabbit appeared to be normal. No signs of corneal or iridial irritation were apparent in any animal, at any examination, throughout the study.
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 / 2 / 2

0 / 2 / 2

0 / 1 / 1

24 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

2 / 2 / 2

2 / 3 / 2

0 / 0 / 0

48 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

1 / 1 / 1

0 / 1 / 0

0 / 0 / 0

72 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 1 / 0

0 / 0 / 0

0 / 0 / 0

Average 24-48-72

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

1.00 / 1.33 / 1.00

0.67 / 1.33 / 0.67

0 / 0 / 0

7 d

- / 0 / 0

- / 0 / 0

- / 0 / 0

- / 0 / 0

- / 0 / 0

- / 0 / 0

Reversibility*)

-

-

-

c.

c.

c.

Average time (unit) for reversion

-

-

-

7 d

72 h

24 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 is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP).
Executive summary:

In an eye irritation study performed according to the EU B.5 test method, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 3 female New Zealand White Rabbit. The eyes were not rinsed 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. An additional observation was conducted on the last 2 animals to be dosed, 7 days after dosing in order to assess the reversibility of the eye reaction. 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. 

One hour after dosing, conjunctival hyperaemia was noted in the treated eye of all 3 rabbits. In 2 animals this was accompanied by conjunctival chemosis and discharge from the treated eye. Twenty-four hours after dosing, discharge was no longer apparent in any animal but hyperaemia and chemosis were noted in all 3 rabbits. Forty-eight hours after dosing, hyperaemia, at a reduced level, was still apparent in all 3 animals whilst conjunctival chemosis was noted in only one rabbit. Seventy-two hours after dosing, the treated eye of 2 animals appeared to be free of all signs of irritation. Observations on the first rabbit, used in the preliminary screen, were discontinued at this time. Slight conjunctival hyperaemia persisted in the treated eye of one animal. Seven days after dosing, the treated eye of this rabbit appeared to be normal. No signs of corneal or iridial irritation were apparent in any animal, at any examination, throughout the study..

 

The calculated mean score for each individual lesion for each animals within 3 scoring times (24, 48 and 72 h) were 1.00 / 1.33 / 1.00 for redness, 0.67 / 1.33 / 0.67 for chemosis and 0.00 / 0.00 / 0.00 for discharge, iris and corneal lesions.

 

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

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