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Diss Factsheets

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
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 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

Test material

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
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
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.