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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study meets generally accepted scientific principles; but limited documentation

Data source

Reference
Reference Type:
other: microfiche
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecyl isocyanate
EC Number:
204-019-7
EC Name:
Octadecyl isocyanate
Cas Number:
112-96-9
Molecular formula:
C19H37NO
IUPAC Name:
1-isocyanatooctadecane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye (untreated) of each animal served as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours (unwashed)
20-30 sec. (washed)
Observation period (in vivo):
days 1, 2, 3, 4, 7 and 14
Number of animals or in vitro replicates:
6 animals (unwashed)
3 animals (washed)
Details on study design:
The test article was instilled, one time, into the conjunctival sac which was formed by gently pulling the lower lid away from the eye. The lids were held together briefly to insure adequate distribution. One eye of each rabbit was treated. The other served as a control. The treated eyes of six rabbits remained umwashed. The treated eyes of three rabbits were flushed for one minute with lukewarm water 20-30 seconds after dosing. The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva on days 1, 2, 3, 4, 7 and 14. Ocular reactions were graded according to the numerical Draize technique. Additional signs were described. The general health of the animals was monitored at each observation time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3, 4, 5, 6 (unwashed eyes)
Time point:
other: day 1
Score:
3.3
Remarks on result:
other: range: 0-8
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3, 4, 5, 6 (unwashed eyes)
Time point:
other: day 2
Score:
1.3
Remarks on result:
other: range: 0-6
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3, 4, 5, 6 (unwashed eyes)
Time point:
other: day 3
Score:
0.3
Remarks on result:
other: range: 0-2
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3, 4, 5, 6 (unwashed eyes)
Time point:
other: day 4
Score:
3
Remarks on result:
other: range: 0-6
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3, 4, 5, 6 (unwashed eyes)
Time point:
other: day 7
Score:
4.3
Remarks on result:
other: range: 4-6
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3, 4, 5, 6 (unwashed eyes)
Time point:
other: day 14
Score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3 (washed eyes)
Time point:
other: day 1
Score:
2.7
Remarks on result:
other: range: 0-6
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3 (washed eyes)
Time point:
other: day 2
Score:
1.3
Remarks on result:
other: range: 0-4
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3 (washed eyes)
Time point:
other: day 3
Score:
0.7
Remarks on result:
other: range: 0-2
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3 (washed eyes)
Time point:
other: day 4
Score:
4
Remarks on result:
other: range: 4-4
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3 (washed eyes)
Time point:
other: day 7
Score:
4
Remarks on result:
other: range: 4-4
Irritation parameter:
other: mean score
Basis:
animal: #1, 2, 3 (washed eyes)
Time point:
other: day 14
Score:
0
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

There was no corneal opacity or iritis in animals with washed or unwashed eyes. Moderate conjunctival irritation, composed primarily of chemosis, was noted in all animals with washed or unwashed eyes. The chemosis reactions were of a delayed nature, showing up in some animals as late as day 7 (unwashed eyes) or as late as day 4 (washed eyes). By day 14, all washed and unwashed eyes appeared normal. There were no abnormal systemic signs noted during the observation period.

Applicant's summary and conclusion

Executive summary:

In an eye irritation study according to EPA OPP 81-4 octadecyl isocyanate was instilled into the conjunctival sac of one eye of 6 (without eye flush) or 3 (with eye flush) rabbits. Eye irritation was assessed after 1, 2, 3, 4, 7 and 14 days using the Draize scale. In this study there was no corneal opacity or iritis in animals with washed or unwashed eyes. Moderate conjunctival irritation, composed primarily of chemosis, was noted in all animals with washed or unwashed eyes. The chemosis reactions were of a delayed nature, showing up in some animals as late as day 7 (unwashed eyes) or as late as day 4 (washed eyes). By day 14, all washed and unwashed eyes appeared normal. There were no abnormal systemic signs noted during the observation period. According to EPA criteria, octadecyl isocyanate was considered to be Category II (corneal involvement or irritation clearing in 8-21 days) in the unwashed and the washed eyes.

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