[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data are given; pre-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

2 animals, scoring at 1 h, 24 h and 8 d

Principles of method if other than guideline:

Before OECD TG 4054 was established, eye irritation was tested using an internal method (BASF Test).

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate

EC Number:

212-028-2

EC Name:

[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate

Cas Number:

751-83-7

Molecular formula:

C33H38P.HO4S

IUPAC Name:

mono[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium hydrogensulphate

Details on test material:

- Name of test material (as cited in study report): C15-Salz, i.e. beta-ionylidene ethyl-triphenylphosphonium hydrogensulphate, solid
- Analytical purity: no data
No further data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

no further data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The talcum powder treated, left eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 mg of solid test substance was placed into the conjunctival sac of the right eye.
The talcum powder treated, left eye served as control.

Duration of treatment / exposure:

not rinsed

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not done

SCORING SYSTEM: BASF scoring system, convertible to Draize score
The eyes of the two rabbits were examined 10 minutes, and 1, 3 and 24 hours after application of the test substance or talcum.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of n=2

Time point:

other: 1 hour - 4 days

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of n=2

Time point:

other: 1 hour - 4 days

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of n=2

Time point:

other: 1 hour - 4 days

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: further findings: erosion, necrosis

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of n=2

Time point:

other: 1 hour - 4 days

Score:

1

Max. score:

2

Reversibility:

not reversible

Irritant / corrosive response data:

Already 1 h after administration of the test substance, marked conjunctivitis (grade 2) was observed in both tested animals. Effects were not reversible at 24 h after instillation (slight effects were also observed in the control eyes treated with talcum - grade 1). At 4 days after application severe necrosis and conjunctivitis was observed. Animals were sacrificed after 4 days to stop suffering.

Any other information on results incl. tables

Table: findings and Draize scores

Material applied	Findings / Draize scores after
	1 h	24 h	4 d / 8 d
Test substance, unchanged, 50 mg	- Erosion - Edema: 2 - Corneal opacity: 2	- Erosion - Edema: 2 - Corneal opacity: 2 - Erythema: 2 at the margins of the eyelids	- Erosion - Edema above the eye - Corneal opacity: 2 - Necrosis at the margins of the eyelid
Talcum	- Erythema: 1 - Edema: 1	- Erythema: 1 no other findings	no findings

Applicant's summary and conclusion

Interpretation of results:

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

Remarks:

Migrated information

Conclusions:

The test substance was classified to cause serious damage to the eyes, based on necrosis observed at 4 days after instillation.