Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol, 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]-

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

issued 31JAN1994

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,2’-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4- methylphenyl)amino]-

IUPAC Name:

Reaction mass of 2,2’-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4- methylphenyl)amino]-

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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).