Registration Dossier

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:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute 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): 1,5-Naphthylene diisocyanate
- Physical state: solid
- Purity: > 99.5 %
- Lot/batch No.: P3YE591000
- 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
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 2300-2700 g
- 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 g

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours post application. If no irritation indices were observed after 72 hours, the study was finished. If eye irritations were observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however for not more than 21 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The 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 - 1
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3
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 - 1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 0.7
Irritation parameter:
chemosis 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:
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 - 1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 0.7
Irritation parameter:
chemosis 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

Any other information on results incl. tables

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        1   1   0  0    -     -     -
Chemosis conjunctivae       0   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        1   1   1  0    -     -     -
Chemosis conjunctivae       0   0   0  0    -     -     -
Animal 3,
Degree of cornea opacity    0   0   0  0    -     -     -
Area of cornea opacity      0   0   0  0    -     -     -
Iris                        0   0   0  0    -     -     -
Redness conjunctivae        1   1   1  0    -     -     -
Chemosis conjunctivae       0   0   0  0    -     -     -

- : no further examination

Animal 1, 1h p.a.: test compound adheres to conjunctiva
Animal 2, 1h-48h p.a.: test compound adheres to conjunctiva
Animal 3, 1h-24h p.a.: test compound adheres to conjunctiva

Applicant's summary and conclusion

Conclusions:



Classification: not irritating
Executive summary:

In an eye irritation study according to OECD TG 405 1,5-Naphthylene diisocyanate (NDI) 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 and 21 days using the Draize scale. In this study NDI shows slight irritant effects (mean irritation index for redness conjunctivae = 0.6) which were fully reversible within 3 days. No irritation effects were seen at cornea or iris. 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 NDI is not an irritant to the eyes.