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EC number: 701-017-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of 2,4/ 2,6 TDI (m-tolylidene diisocyanate, CAS 26471-62-5) in excess and m-TDA (diaminotoluene, CAS 25376-45-8) forming Biuret structures via non-isolated polyurea intermediates
- IUPAC Name:
- Reaction product of 2,4/ 2,6 TDI (m-tolylidene diisocyanate, CAS 26471-62-5) in excess and m-TDA (diaminotoluene, CAS 25376-45-8) forming Biuret structures via non-isolated polyurea intermediates
- Details on test material:
- - Name of test material (as cited in study report): Desmodur VP.PU 60WF14
- Physical state: liquid
- Purity: 100 %
- Lot/batch No.: P1DE000345
- Storage condition of test material: 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
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.6-2.9 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one untreated eye of test animals served as control
- Amount / concentration applied:
- Amount: 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours post application; thereafter the animals were monitored on day 7, 14, 21 and 28 after application because of observed eye irrtations
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eye was rinsed approx. 24 hours following instillation
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: mean score after 72 hours: 2.0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2 - 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: mean score after 72 hours: 2.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2 - 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: mean score after 72 hours: 2.7
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 days
- Remarks on result:
- other: mean score after 72 hours: 2.0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2 - 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 28 days
- Remarks on result:
- other: mean score after 72 hours: 2.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2 - 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 2.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 1.7
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: mean score after 72 hours: 2.0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2 - 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: mean score after 72 hours: 2.3
Any other information on results incl. tables
Table 1: Summary of irritant effects on the eye (Exposure: 24 hours):
Observation time 1h
24h 48h 72h day7 day14 day21 day28
Animal 1
Degree of cornea opacity 0 2 2 2 3* 3 3 3
Area of cornea opacity 0 3 3 3 3 2 2 1
Iris 0 0 1 1 1 0 0 0
Redness conjunctivae 2 2 3 3 3 2 2 1
Chemosis conjunctivae 2 3 3 2 2 2 2 2
Animal 2
Degree of cornea opacity 0 2 2 2 2* 1 1 0
Area of cornea opacity 0 3 3 2 1 1 1 0
Iris 0 0 0 1 0 0 0 0
Redness conjunctivae 2 2 2 3 3 1 1 0
Chemosis conjunctivae 2 3 2 2 2 0 0 0
Animal 3
Degree of cornea opacity 0 2 2 1 1* 0 0 0
Area of cornea opacity 0 3 3 2 1 0 0 0
Iris 0 0 0 0 0 0 0 0
Redness conjunctivae 2 2 2 2 3 1 0 0
Chemosis conjunctivae 2 3 2 2 2 1 0 0
* For the exact clarification of the cornea opacity and the area of cornea opacity, in addition, a fluorescein test was carried
out; therefore, the eyes were rinsed again.
Animal 1, 1h and 24h p.a.: test compound adhered to cornea and conjunctiva
14d - 28d p.a.: alopecia around the eye, vascularization
Animal 2, 1h and 24h p.a.: test compound adhered to cornea and conjunctiva
14d - 28d p.a.: slight alopecia around the eye
14d - 21d p.a.: vascularization
Animal 3, 1h and 24h p.a.: test compound adhered to cornea and conjunctiva
7d - 21d p.a.: alopecia around the eye
Applicant's summary and conclusion
- Conclusions:
Classification: not irritating- Executive summary:
In an eye irritation study according to OECD TG 405 Desmodur VP.PU 60WF14 was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48, 72 hours and 7, 14, 21 and 28 days using the Draize scale. In this study Desmodur VP.PU 60WF14 revealed eye irritantion effects at cornea and conjunctivae. No irritation effects were seen at the iris. In one animal effects at cornea and conjunctivae (redness and chemosis) were not reversible within the 28-day recovery period. No systemic intolerance reactions were observed.
According to classification criteria Desmodur VP.PU 60WF14 caused serious damage to the eyes without reversibility within 28 days.
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