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EC number: 911-490-9 | CAS number: -
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- Ecotoxicological Summary
- Aquatic toxicity
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

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:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- 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
- 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
Constituent 1
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).
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