2-Butyne-1,4-diol, polymer with 2-(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, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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:

2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated

EC Number:

614-503-3

Cas Number:

68441-62-3

Molecular formula:

(C3H7O2)xC4H4O2Br2(C4H9O2)y with x + y = 2.5

IUPAC Name:

2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated

Constituent 2

Reference substance name:

Triethyl phosphate

EC Number:

201-114-5

EC Name:

Triethyl phosphate

Cas Number:

78-40-0

Molecular formula:

C6H15O4P

IUPAC Name:

triethyl phosphate

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): B251, suspensions in 1% tragacanth mucilage.
- Lot/batch No.: Batch No. 1106
- Physical state: liquid
- Analytical purity: not specified

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
- Age at study initiation: not specified
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 27 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 65-85
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

once without rinsing the eyes thereafter

Observation period (in vivo):

reading of reactions of all rabbits were made at 1 hour, at 24, 48 and 72 hours and at 7, 9 and 12 days after treatment.

Number of animals or in vitro replicates:

3 (male rabbits)

Details on study design:

At the day of testing both eyes of each rabbit were examined with the aid of a hand slit-lamp. Only those rabbits without eye defects or irritation were
used. A quantity of 0.1 ml of the substance was placed in the left eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup
into which the test substance was placed. The lids were then gently held together for one second and the rabbit was released. The other eye remaining untreated, served as a control. The treated eyes were not rinsed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Regarding the scores of the individual animals, 2/3 animals had a cornea opacity score (mean 24, 48 and 72 hours) >1 (1.7 and 1.3, resp.).

Results 2

Irritation parameter:

other: cornea: area involved

Basis:

mean

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 12 days

Remarks on result:

other: Individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7

Results 6

Irritation parameter:

other: conjunctivae: discharge

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

The conjunctivae of all rabbits (individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2) and the cornea of two rabbits (two animals with a mean (24, 48 and 72 hours) cornea opacity score >1 (1.7 and 1.3, resp.)) were slightly to moderately irritated the first two days after treatment. After 48 hours the eyes recovered. The effects had disappeared at 7 days after application in one rabbit. In the other two rabbits a slight redness of the conjunctiva was still observed, which had disappeared 12 days after application. The mean (24, 48 and 72 hours) chemosis score was 1 (individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7) and this effect had disappeared after 72 hours. No iritis was observed.

Any other information on results incl. tables

Numerical grades awarded to the ocular reactions elicited by B 251
Rabbit No.	Region of the eye			Hours (h)/days(d) after application
			Pre-test	1h	24h	48h	72h	7d	9d	12d
1	Cornea	Opacity	0	1	2	2	1	0	0	0
		Area involved	0	4	4	2	1	0	0	0
	Iris		0	0	0	0	0	0	0	0
	Conjunctiva	Redness	0	1	2	2	2	1	1	0
		Chemosis	0	0	1	1	0	0	0	0
		Discharge	0	0	1	0	0	0	0	0
2	Cornea	Opacity	0	0	2	1	1	0	0	0
		Area involved	0	0	3	2	1	0	0	0
	Iris		0	0	0	0	0	0	0	0
	Conjunctiva	Redness	0	1	2	2	1	0	0	0
		Chemosis	0	0	3	2	0	0	0	0
		Discharge	0	0	0	0	0	0	0	0
3	Cornea	Opacity	0	0	0	0	0	0	0	0
		Area involved	0	0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0	0
	Conjunctiva	Redness	0	1	2	1	1	1	1	0
		Chemosis	0	0	1	1	0	0	0	0
		Discharge	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Polyol IXOL B251 was irritating to the eyes of rabbits

Executive summary:

The primary irritation of Polyol IXOL B251 to the rabbit eye was investigated in a study performed according to OECD guideline 405 and under GLP (Duphar B.V., 1985c). To this purpose, 0.1 ml of the test substance was placed into the conjunctival sac of one eye of three male rabbits of the New Zealand White strain. The eyes were examined and the ocular reactions graded at 1 hour, at 24, 48 and 72 hours and at 7, 9 and 12 days after treatment.

The conjunctivae of all rabbits (individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2) and the cornea of two rabbits (two animals with a mean (24, 48 and 72 hours) cornea opacity score >1 (1.7 and 1.3, resp.)) were slightly to moderately irritated the first two days after treatment. The effects had disappeared at 7 days after application in one rabbit, while in the other two rabbits a slight redness of the conjunctiva was still observed, which had disappeared 12 days after application. The mean (24, 48 and 72 hours) chemosis score was 1 (individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7) and this effect had disappeared after 72 hours. No iritis was observed. Based on the mean (24, 48 and 72 hours) cornea opacity scores of 1.7 and 1.3 in two animals, classification for eye irritation is warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.