triphenyl(((1r,4r)-4-((E)-prop-1-en-1-yl)cyclohexyl)methyl)phosphonium iodide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to the OECD guideline 405 and in compliance with GLP. The substance used for read across (Triphenyl-(4-vinyl)cyclohexyl-methylphospohniumiodid, D 6) is structurally very similar to the registered substance Triphenyl-(4-propenyl)cyclohexyl-methylphosphoniumiodid (E 6). The only difference concerns the length of side chain in para position of the hexylring being a vinyl group for D 6 and a propenyl group for E 6. Therefore a read-across from D 6 to E 6 is considered reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1171067-76-1

IUPAC Name:

1171067-76-1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2940 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal served as control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

The treated eye was rinsed out with deionised water carefully one hour after instillation and 24 hours after instillation once again.

Observation period (in vivo):

60 minutes, 24, 48 and 72 hours and from day 4 to day 21 after instillation of the test item

Number of animals or in vitro replicates:

1 male

Details on study design:

The test item was administered as the original substance after crushing with a pestle and mortar to a fine dust.
A volume of 0.1 ml of the test item was instilled into the conjunctival sac of one eye after gently pulling the lower Iid away from the eyeball. The Iids
were then held together gently for approximately 1 second in order to prevent loss of the material. The other eye of the same animal, which remained
untreated, served as control.
The treated eye was rinsed out with deionised water carefully one hour after instillation and 24 hours after instillation once again.

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:

2.33

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Max. score:

2

Remarks on result:

other: not evaluable because the eye was completely swollen up

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

4

Max. score:

4

Irritant / corrosive response data:

A single instillation of D6 into the conjunctival sac of one albino rabbit caused serious irreversible effects to the cornea and necrotic irreversible
effects to the conjunctivae. A serious opaque cornea was observed till the end of the 21 day observation period.
The iris could not be evaluated because the eye was completely swollen up and because of the serious purulent secretion or of the opaque cornea,
respectively. A serious oedema of the conjunctivae faded slowly and at the end of the 21 day observation period this effect was not more observed, however the necrosis was still observed at the end of the 21 day observation period.

Other effects:

Signs of systemic effects of the test item were not observed.
The control eye of the animal showed no alterations at any observation time.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study with specific view on conjunctivae necrosis not being reversible after 21 day, the substance has to be cosidered as inducing irreversible effects on the eye.