[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

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 - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

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 February 24, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

September 19, 1984

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

EC Number:

613-004-8

Cas Number:

62285-89-6

Molecular formula:

C28 H32 O2 P . Cl

IUPAC Name:

[(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-butenyl]triphenylphosphonium chloride

Details on test material:

- Name of test material (as cited in study report): C5-NPG-ACETAL
- Substance Number: 92/128
- Physical state: white powder
- Analytical purity: 99 %
- Lot/batch No.: 92/33 - 1 ((Technikum B 15 S)
- Stability under test conditions: The stability of the test substance in aqua bidest. for at least 4 hours was confirmed by analysis.
- Storage condition of test material: refrigerator; exclusion of moisture

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 animals
- Weight at study initiation: male: 3.05 kg;
- Housing: Single housing
- Diet (e.g. ad libitum): KLIBA Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): About 250 ml tap water per animal per day
- Acclimation period: for at least 1 week

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated left eye served as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 35 mg of the comminuted test substance)

Duration of treatment / exposure:

Single application to the conjunctival sac of the right eyelid

Observation period (in vivo):

15 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was not washed out.

SCORING SYSTEM: Draize system

READINGS: 1 h, 24 , 48 h, 72 , 8 days and 15 days after application

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no

GENERAL OBSERVATIONS: A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks:

within 15 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: within 15 days

Irritant / corrosive response data:

The average score (24 to 72 hours) for irritation was calculated to be 2.0 for conjunctivae redness and 4.0 for chemosis.
No mean was calculated for corneal opacity and iris because the irritation index could not be determined 48 and 72 hours after application due to severe suppuration.

The findings were not considered to be reversible, thus the study was terminated on day 15.

Symptoms observed are described in the table below.
The following findings indicate that the test substance may be severely irritant to the eye: pannus, staphyloma.

Any other information on results incl. tables

Table Eye irritation

Animal	Reading	Cornea		Iris	Conjunctiva	Chemosis		Additional findings
		Opacity	Area		Redness	Swelling	Discharge
1	1 h	3	4	0	2	3	2	discharge of blood
1	24 h	3	3	0	2	4	2	discharge of blood, loss of corneal tissue
1	48 h	-	-	-	2	4	3	suppuration, discharge of blood,
1	72 h	-	-	-	2	4	3	suppuration, discharge of blood,
1	8 d	-	-	-	2	4	3	suppuration, loss of flair at margins of eyelids
1	15 d	-	-	-	2	2	2	small retractions in the eyelids, suppuration, loss of flair at margins of eyelids, staphyloma, pannus, study discontinued because of severe irritation
mean	24 - 72 h total	-	-	-	2.00	4.00	-

Index for cornea opacity, area and iris could not be read because of severe suppuration.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information

Conclusions:

Classification: risk of serious damage to eyes