Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(11E)-11,12-dibromo-7-(chloromethyl)-2,6,9,14,18-pentaoxanonadec-11-ene-4,16-diol; (12E)-12,13-dibromo-1,21-dichloro-8-(chloromethyl)-5,17-bis(methoxymethyl)-4,7,10,15,18-pentaoxahenicos-12-ene-2,20-diol; (8E)-8,9-dibromo-13-(hydroxymethyl)-2,6,11,15-tetraoxahexadec-8-en-4-ol; (8E)-8,9-dibromo-2,6,11,15-tetraoxahexadec-8-ene-4,13-diol

EC Number:

617-903-6

Cas Number:

86675-46-9

Molecular formula:

(C4H9O2)xC4H4O2Br2(C4H9O2)y with (x+y)= 2.5

IUPAC Name:

(11E)-11,12-dibromo-7-(chloromethyl)-2,6,9,14,18-pentaoxanonadec-11-ene-4,16-diol; (12E)-12,13-dibromo-1,21-dichloro-8-(chloromethyl)-5,17-bis(methoxymethyl)-4,7,10,15,18-pentaoxahenicos-12-ene-2,20-diol; (8E)-8,9-dibromo-13-(hydroxymethyl)-2,6,11,15-tetraoxahexadec-8-en-4-ol; (8E)-8,9-dibromo-2,6,11,15-tetraoxahexadec-8-ene-4,13-diol

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): IXOL M125
- Physical state: treacly liquid
- Lot/batch No.: 1013
- Purity: >99%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: TNO, Zeist, The Netherlands.
- Weight at study initiation: 2.5-3.0
- Housing: individually in stainless steel wire cages. Sawdust, woodchips, or other extraneous material that might produce eye irritation were excluded.
- Diet (e.g. ad libitum): 80 g food (a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) during the acclimatization perio. During the experiment the food was available ad libitum.
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 55-65
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

other: cornea: area involved

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: individual animal mean (24, 48 and 72 hours) scores: 0.67, 0 and 0

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: individual animal mean (24, 48 and 72 hours) scores: 1.0, 0 and 0.67

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: individual animal mean (24, 48 and 72 hours) scores: 0.33, 0 and 0

Results 6

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: individual animal mean (24, 48 and 72 hours) scores: 0.67, 0 and 0.67

Irritant / corrosive response data:

The conjunctiva was slightly irritated in all rabbits one hour after treatment. The palpebra conjunctiva of two rabbits was also slightly damaged from one hour till 72 hours after application. The cornea of one rabbit was slightly irritated from 24 hours till 72 hours after treatment. The irritation had disappeared in one rabbit at 24 hours, in the second rabbit at 72 hours and in the third rabbit at 7 days after treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is slightly irritating to rabbit eyes.

Executive summary:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, 0.1mL of the test substance was placed in the conjunctival sac of one eye of three New Zealand White rabbits. The eyes were examined for 7 days. The conjuctiva was slightly irritated in all rabbits one hour after treatment. The palpebral conjunctiva of two rabbits was also slightly damaged from one hour till 72 hours after application. The cornea of one rabbit was slightly irritated from 24 hours till 72 hours after treatment. The irritation had disappeared in one rabbit at 24 hours, in the second at 72 hours and in the third at 7 days after treatment. Based on these observations, Polyol IXOL M125 is considered to be a slight irritant to the eye.