Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-05-28 - 2001-05-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate; (propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate

EC Number:

600-028-9

Cas Number:

1001254-87-0

Molecular formula:

Exact identification is not feasible

IUPAC Name:

(propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate; (propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate

Test material form:

other: solid

Details on test material:

Test substance: Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked
Batch no. 02/01/1617. Batch no. 02/01/1617. Purity not reported

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: 
- Source: Charles River Deutschland (Germany)
- Sex: male
- Age: at least 6 weeks old
- Controls: untreated eye
- Diet: ad libitum, Altromin special diet for rabbits
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: identical animal, left eye

Amount / concentration applied:

undiluted, test substance was grounded to a powder using a mortar
Amount applied: 0.82 mg, a volume of approximately 0.1 ml/animal

Duration of treatment / exposure:

not rinsed; no removal of test substance

Observation period (in vivo):

1, 24, 48 and 72 hours after administration

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

- not rinsed
- Ophthalmoscopic examination with a slit lamp: prior to the administration and 1, 24, 48 and 72 hours after administration; 24 hours after
administration, the eyes were treated additionally with fluorescein and examined.
- Scoring system: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.78

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0
- Conjunctivae (Redness): 0.78
- Conjunctivae (Chemosis): 0.11

Other effects:

There were no systemic intolerance reactions.

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the test item showed only slightly eye irritating effects in rabbits.

Executive summary:

A study was performed to examine eye irritating effects of test item according to OECD TG 405.

An amount of 0.82 mg was instilled into the conjunctival sac of the right eye of each of three male rabbits, and the untreated left eye served as control.

Observations were made 1, 24, 48 and 72 hours after instillation.

Under the present test conditions, test item caused the following effects: The iris and conjunctivae was not effected after instillation of the test substance. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 72 hours. There were no systemic intolerance reactions.

Therefore, under the conditions of this study test item showed only slightly eye irritating effects in rabbits.