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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.