Registration Dossier

Diss Factsheets

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:
2007
Report date:
2007

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

Constituent 1
Reference substance name:
4,4'-Methylenediphenyl diisocyanate, oligomers, reaction products with 2-ethylhexan-1-ol
IUPAC Name:
4,4'-Methylenediphenyl diisocyanate, oligomers, reaction products with 2-ethylhexan-1-ol
Constituent 2
Reference substance name:
Desmodur MT
IUPAC Name:
Desmodur MT
Details on test material:
- Name of test material (as cited in study report): Desmodur MT
- Physical state: liquid
- Purity: 100 % (as indicated by the sponsor)
- Lot/batch No.: LL6-077
- 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: 2.4-2.7 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
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was not rinsed for at least 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:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
iris score
Basis:
animal #1
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 #1
Time point:
other: 24, 48, 72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1.0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
iris score
Basis:
animal #2
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 #2
Time point:
other: 24, 48, 72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1.0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 0.7
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
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:
0 - 3
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1.7
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3

Any other information on results incl. tables

Table 1: Summary of irritant effects on the eye

 

Observation time           1h  24h  48h  72h  day7 day14 day21
Animal 1
Degree of cornea opacity    0    0    0   0    -     -     -     
Area of cornea opacity      0    0    0   0    -     -     -     
Iris                        0    0    0   0    -     -     -     
Redness conjunctivae        2    2    1   0    -     -     -     
Chemosis conjunctivae       1    1    0   0    -     -     -     
Animal 2
Degree of cornea opacity    0    0    0   0    -     -     -     
Area of cornea opacity      0    0    0   0    -     -     -     
Iris                        0    0    0   0    -     -     -     
Redness conjunctivae        3    2    1   0    -     -     -     
Chemosis conjunctivae       1    1    1   0    -     -     -     
Animal 3
Degree of cornea opacity    0    0    0   0    -     -     -     
Area of cornea opacity      0    0    0   0    -     -     -     
Iris                        1    0    0   0    -     -     -     
Redness conjunctivae        3    3    2   0    -     -     -     
Chemosis conjunctivae       1    1    0   0    -     -     -    

- = no further examination 

Animal 1, 2 and 3 (1hour p.a.): test compound adhered to cornea and conjunctiva

               

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:



Classification: not irritating
Executive summary:

In an eye irritation study according to OECD TG 405 Desmodur MT was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. The mean irritation index for redness of conjunctivae was 1.2 of max. 3 (1.0 - 1.7), the mean irritation index for chemosis of conjunctivae was 0.4 of max. 4 (0.3 - 0.7). Signs were fully reversible in all animals within three days. No irritation effects were seen at cornea or iris 24 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed.

 

According to classification criteria Desmodur MT is not an irritant to the eyes.

 

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