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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:
October 9th-30th, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
issued 31JAN1994

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Physical appearance: colourless viscous liquid
Storage conditions: At room temperature

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: 3.1 kg
- Housing: individually in a suspended metal cage
- Diet: ad libitum (STANRAB SQC Rabbit diet, Special Diets Services, Witham, Essex, UK)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 54 - 74
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: According to the OECD guideline.

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
other: Ectropion and circumcorneal vascularisation persisted at the end of observation. Effects were considered irreversible
Remarks on result:
other: irreversible effects
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: Ectropion and circumcorneal vascularisation persisted at the end of observation. Effects were considered irreversible
Remarks on result:
other: irreversible effects
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: Ectropion and circumcorneal vascularisation persisted at the end of observation. Effects were considered irreversible
Remarks on result:
other: irreversible effects
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
other: Ectropion and circumcorneal vascularisation persisted at the end of observation. Effects were considered irreversible
Remarks on result:
other: irreversible effects
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Irritant / corrosive response data:
Areas of diffuse corneal opacity were noted in the treated eye one hour after treatment and at the 24 and 48-hour observations with areas of translucent corneal opacity noted at the 72-hour and 7-day observations. Diffuse corneal opacity was also noted at the 14-day observation.

Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour and 7-day observations with minimal conjunctival irritation noted at the 14-day observation.
Other effects:
Ectropion was noted in the treated eye at the 7, 14 and 21-day observations with circumcorneal vascularisation invading o to 2 mm onto the cornea also noted at these times. These reactions were considered to be irreversible.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
An in vivo eye irritation test was performed according to OECD guideline and GLP principles. Based on irreversibel effects to the eye, BISOMER PTE is classified cat. 1 for eye irritancy.
Executive summary:

An in vivo eye irritation test was performed according to the OECD guideline and GLP principles. One rabbit was treated and observed for 21 days. The average scores for observations at 24, 48 and 72 hours were 1.3 (cornea score), 1 (iris score) and 2 (chemosis score). At the end of the observation period of 21 days, ectropion was noted in the treated eye with circumcorneal vascularisation invading up to 2 mm onto the cornea. Since these reactions were considered to be irreversible, BISOMER PTE is classified cat. 1 for eye irritancy (corrosive).