propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1984

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

EC Number:

701-363-4

Molecular formula:

Not specified UVCB - Reaction product of ethoxylated (0-7 EO) propylidenetrimethanol with acrylic acid and dibutylamine (propylidenetrimethanol with acrylic acid : dibutylamine = 5:1)

IUPAC Name:

propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

Details on test material:

- Name of test material (as cited in study report): Laromer LR 8869
- Physical state: liquid, achromatic to slight yellowish
- Analytical purity: 99.8
- Purity test date: 02/1992
- Lot/batch No.: 1/92
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator, exclusion of light

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: young adult females
- Weight at study initiation: 3.1 - 3 5kg
- Housing: individually in stainless steel cages with wire mesh walk floors (40 X 51cm)
- Diet (e.g. ad libitum): KLIBA lab diet 341 ad lib. (app. 130g/animal/day)
- Water (e.g. ad libitum): tap water ad lib. (app. 250ml/day)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

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

Duration of treatment / exposure:

once, substance not washed out

Observation period (in vivo):

8 days (study terminated after complete reversion of all effects)
observations after 1h, 24h, 48h, 72h, 8 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
not washed out

SCORING SYSTEM: see additional information

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h - 8 days

Score:

0

Max. score:

2

Remarks on result:

other: no effects on the iris were observed

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 - 72h (mean)

Score:

0

Max. score:

2

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal: #2+#3

Time point:

other: 24-72h (mean)

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h - 72h (mean)

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #2 + #3

Time point:

other: 24 - 72h (mean)

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24h - 72h (mean)

Score:

0

Max. score:

4

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #2 + #3

Time point:

other: 24h-72h (mean)

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h (animal 2) or 8 days (animal 3)

Any other information on results incl. tables

Readings	Animal	Cornea		Iris	Conjunctiva			Symptoms
		Opacity	Area		Redness	Swelling	Discharge
1h	1	0	0	0	3	1	2
	2	0	0	0	2	1	2
	3	0	0	0	2	1	2
24h	1	0	0	0	2	0	0
	2	1	4	0	3	2	2	SR, DB
	3	1	3	0	3	1	2	SR
48h	1	0	0	0	1	0	0
	2	1	3	0	3	1	1	SR
	3	1	2	0	3	1	1	SR
72h	1	0	0	0	0	0	0
	2	1	3	0	3	1	1	SR
	3	1	2	0	2	1	0	SR
8 D	1	0	0	0	0	0	0
	2	0	0	0	0	0	0	SR
	3	0	0	0	0	0	0	SR

SR: small retractions in the eyelids

DB: discharge of blood

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information

Conclusions:

Under the test conditions chosen and considering the described findings, the test substance gives indication of an irritant property to the eye.

Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris, or cornea was assessed in 3 white Vienna rabbits, subjected to a single ocular application of 0.1ml of the test substance on day 0 . The average score (24 to 72h) for irritation was calculated to be 0.7 for corneal opacity, 0.0 for iris, 2.1 for conjunctivae redness, and 0.7 for chemosis. The findings were reversible in all animals within 8 days, thus the study was terminated.