Ethyltriphenylphosphonium iodide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: US Federal Hazardous Substances Control Act

Version / remarks:

Code of Federal Regulations, Titel 16, Chapter II, 1977

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Ethyltriphenylphosphonium iodide

EC Number:

225-245-2

EC Name:

Ethyltriphenylphosphonium iodide

Cas Number:

4736-60-1

Molecular formula:

C20H20IP

IUPAC Name:

ethyltriphenylphosphonium iodide

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Albino rabbits (no further data)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the counter lateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye

Duration of treatment / exposure:

single instillation without washing

Observation period (in vivo):

Reading time points: 24, 48 and 72 hours after instillation

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM: according to Draize 1959

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

1

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3, #4, #5

Time point:

24/48/72 h

Score:

3

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #6

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal: #5

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #2, #4

Time point:

24/48/72 h

Score:

3.66

Max. score:

4

Irritant / corrosive response data:

Within 24 hours following application, signs of irritation included moderate to severe corneal opacity, mild iritis, and severe conjunctivitis in all rabbits. Blanching of the conjunctivae and nictitating membrane was noted in two rabbits during the observation period. Irritative effects were relatively unchanged during the 72-hour observation period.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis	Discharge	Other
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4	Max. score: 3
24 h	2/3/2/2/2/2	1/1/1/1/1/1	3/3/3/3/3/3	3/3/3/3/3/2	3/3/3/3/3/3	A
48 h	2/3/2/2/2/2	1/1/1/1/1/1	3/3/3/3/3/3	3/4/3/4/3/2	3/3/3/3/3/3	A
72 h	2/4/2/2/2/2	1/B/1/1/1/1	3/3/3/3/3/2	3/4/3/4/4/2	3/3/3/3/3/2
Average 24h, 48h, 72h	2/3,33/2/2/2/2/2	1/1/1/1/1/1	3/3/3/3/3/2,66	3/3,66/3/3,66/3,33/2
Area effected	4/4/4/4/4/4
Reversibility*)	n	n	n	n

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

B=Unable to score due to swelling, A = In two animals entire nictitating membrane and diffuse areas of conjunctivae blanched (whitened).

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Ethyltriphenylphosphonium iodide induced moderate to severe corneal opacity, mild iritis, severe conjunctivitis and blanching of the conjunctivae and nictitating membrane. The effects were non reversible within the observation period.
Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
According to the criteria of REGULATION (EC) No 1272/2008 as well as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations, Ethyltriphenylphosphonium iodide has the potential to seriously damage the eyes and is classified in Category 1 (irreversible effects on the eye).