2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2002-11-18 to 2002-11-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study; GLP study without deviation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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:

Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane

EC Number:

607-997-7

Cas Number:

26776-30-7

Molecular formula:

Exact identification is not feasible

IUPAC Name:

Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane

Test material form:

liquid: viscous

Details on test material:

90 % Hexamehylendiisocyanate, oligomeric, caprolactam blocked
10 % Solvesso

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:

0.1 ml undiluted test substance

Duration of treatment / exposure:

not rinsed; no removal of test substance

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days 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, 72 hours and 7 days 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:

0.89

Max. score:

3

Reversibility:

fully reversible within: 7days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0
- Conjunctivae (Redness): 0.89
- Conjunctivae (Chemosis): 0

Other effects:

Instillation of 0.1 ml test substance into one of each eye of three rabbits resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 72 hours in two animals and within 7 days in the other animal. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fuorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals. There was no evidence of ocular corrosion. Remnants of the test substance were presented on the outside of the eyelids of all animals from 1 to 72 hours after instillation. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

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, which do not meet criteria according to EU Directive 67/548/EEC to be classified as "irritant to eyes".

Executive summary:

A study was performed to examine eye irritating effects of the test item according to OECD TG 405. An amount of 0.1 ml of

2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane (90 % in solvent) 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, 72 hours and 7 days after instillation. The treatment resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 72 hours in two animals and within 7 days in the other animal. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fuorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals. There was no evidence of ocular corrosion. Remnants of the test substance were presented on the outside of the eyelids of all animals from 1 to 72 hours after instillation. There were no symptoms of systemic toxicity and no mortality occurred.

Therefore, under the conditions of this study the test item (90% active ingredient in solvent) showed only slightly eye irritating effects in rabbits, which do not meet criteria according to EU Directive 67/548/EEC to be classified as "irritant to eyes".