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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- post-observation period only 8 days
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethylene diisocyanate
EC Number:
212-485-8
EC Name:
Hexamethylene diisocyanate
Cas Number:
822-06-0
Molecular formula:
C8H12N2O2
IUPAC Name:
1,6-diisocyanatohexane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht (Extertal, Germany)
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (mean weight)
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml (undiluted)
Duration of treatment / exposure:
24 hours for left eye (not rinsed after instillation);
right eye rinsed with saline 30 seconds after instillation
Observation period (in vivo):
1, 24, 48, 72 hours and 8 days after instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): right eye rinsed with saline 30 seconds after instillation; left eye remained unrinsed

SCORING SYSTEM: according to DRAIZE

TOOL USED TO ASSESS SCORE: ophthalmoscope, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48 h
Max. score:
2
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Max. score:
2
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48 h
Max. score:
2
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Max. score:
4
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
iris score
Basis:
animal: #3, #4, #6
Time point:
72 h
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
iris score
Basis:
animal: #3, #4, #6
Time point:
24/48 h
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
cornea opacity score
Basis:
animal: #3, #4, #6
Time point:
72 h
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
cornea opacity score
Basis:
animal: #3, #4, #6
Time point:
24/48 h
Reversibility:
other: Not reversible within 8 days.
Remarks on result:
other: Eye totally swollen shut. Evaluation/scoring not possible.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1 - 2
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 1.7
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0 - 2
Max. score:
2
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 1.3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 3.0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 4.0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 72 hours
Score:
3
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours not determinable since eye completely swollen after 24 and 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 72 hours
Score:
2
Max. score:
2
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours not determinable since eye completely swollen after 24 and 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2 - 3
Max. score:
3
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 2.7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 4.0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2 - 3
Max. score:
3
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 2.3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 4.0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 2.0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 4.0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 72 hours
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours not determinable since eye completely swollen after 24 and 48 hours
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 72 hours
Score:
2
Max. score:
2
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours not determinable since eye completely swollen after 24 and 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 2.0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 4.0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2 - 3
Max. score:
3
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 2.3
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 8 days
Remarks on result:
other: mean score after 72 hours: 4.0

Any other information on results incl. tables

One hour to 8 days after instillation (left eye, not rinsed) corneal opacity, irritation of the iris, conjunctival redness and chemosis were observed in all animals (for details see table overall irritation / corrosion results). All effects had a tendency to get worse during the 8-day post-observation period. Mean cornea scores and mean iris scores of animals no. 3, 4 and 6 were not determinable since eyes were completely swollen after 24, 48 and 72 hours. Damage to the eye was already caused 30 seconds after instillation (right eye, rinsed with saline 30 sec.after instillation). The examination of the eyes was partly difficult due to swelling.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

In an acute eye irritation/corrosion test 1,6-hexamethylene diisocyanate was corrosive to the eyes of rabbits according to OECD TG 405. Damage to the eye was already caused 30 seconds after instillation (right eye rinsed with saline 30 sec. after instillation). One hour 

to 8 days after instillation (left eye not rinsed) corneal opacity, irritation of the iris, conjunctival redness and chemosis were observed in  all animals.