Ethyltriphenylphosphonium iodide

Endpoint summary

Description of key information

Skin irritation: not irritating (in vivo study according to US Federal Hazardous Substances Control Act, Code of Federal Regulations, Titel 16, Chapter II, 1977)

Eye irritation: irreversible effects on the eye (in vivo study according to US Federal Hazardous Substances Control Act, Code of Federal Regulations, Titel 16, Chapter II, 1977)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

other: US Federal Hazardous Substances Control Act

Version / remarks:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Albino rabbits (no further data)

Type of coverage:

occlusive

Preparation of test site:

other: shaved and shaved/abraded

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): undiluted moistened with physiological saline

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Patch test on shaved and shaved/abraded skin.
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes

SCORING SYSTEM: Draize scoring system

Five-tenths gram of each undiluted sample which was moistered with physiological saline to form a paste was applied under one inch-square surgical gauze patch, two layers thick, to an intact skin area and an abraded skin area on each of six albino rabbits. The application sites were prepared by clipping the hair from the saddle area of the rabbits. The abraded areas were prepared by making minor epidermal incisions with a hypodermic needle. The abrasions were sufficiently deep to penetrate the epidermis but not to induce bleeding. Each patch was held in place with two strips of one-inch adhesive tape. After application of the patches, the trunk of each rabbit was wrapped with rubber which was secured with staples. An outer layer of gauze and tape was placed around the trunk of the animals. The animals were restrained in Newmann harnesses for 24 hours.
At the end of the 24-hour exposure period, the patches were removed and the residual sample was gently removed from the skin with a moistened towed. The reactions were scored immediately after removal of the patches (24-hour reading), and again two days later (72-hour reading). The scoring system used is identical to the scoring system of OECD guideline 404 (version 2002).

Irritation parameter:

erythema score

Basis:

animal: 6/6

Time point:

other: 24, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact as well as abraded skin

Irritation parameter:

edema score

Basis:

animal: 6/6

Time point:

other: 24, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact as well as abraded skin

Irritant / corrosive response data:

No irritation or corrosive effects were noted at either the 24 or 72 hour reading.

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritation was caused by 24 hours occlusive exposure to Ethyltriphenylphosphonium iodide.
According to the criteria of REGULATION (EC) No 1272/2008, Ethyltriphenylphosphonium iodide does not have to be classified and has no obligatory labeling requirement for skin irritation.
According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations, Ethyltriphenylphosphonium iodide does not have to be classified for skin irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

other: US Federal Hazardous Substances Control Act

Version / remarks:

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

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

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Albino rabbits (no further data)

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

Irritation parameter:

cornea opacity score

Basis:

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

Time point:

24/48/72 h

Score:

2

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Irritation parameter:

iris score

Basis:

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

Time point:

24/48/72 h

Score:

1

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

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

Time point:

24/48/72 h

Score:

3

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal: #6

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal: #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal: #5

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

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.

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).

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Ethyltriphenylphosphonium iodide was not irritating in an in vivo skin irritation test according to US Federal Hazardous Substances Control Act, Code of Federal Regulations, Titel 16, Chapter II, 1977.

In an in vivo eye irritation study according to US Federal Hazardous Substances Control Act, Code of Federal Regulations, Titel 16, Chapter II, 1977, Ethyltriphenylphosphonium iodide induced moderate to severe corneal opacity, mild iritis, severe conjunctivitis and blanching of the conjunctivae and nictitating membrane. The effects were not reversible within the observation period of 72 hours.

Justification for classification or non-classification

In an in vivo study, no skin irritation was caused by 24 hours occlusive exposure to Ethyltriphenylphosphonium iodide.

According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004), Ethyltriphenylphosphonium iodide does not have to be classified for skin irritation.

According to the criteria of REGULATION (EC) No 1272/2008, Ethyltriphenylphosphonium iodide does not have to be classified and has no obligatory labelling requirement for skin irritation.

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). This 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 an in vivo study. Category 1 is justified as in one animal the mean score for corneal opacity was 3.33.

Ethyltriphenylphosphonium iodide is not classified for respiratory irritation because of lacking data.