benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 23 to February 6, 1990

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD GLP in the testing of chemicals [C(81) final], regulation enforced by the Italian Health Authority (D.M. dated June 26, 1986 as published in G.U. no. 198, August 27, 1986 and D.M.dated April 28, 1988 as published in G.U. no. 107, May 9, 1988.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

479-100-5

EC Name:

-

Cas Number:

577705-90-9

Molecular formula:

C38H36F6O2NP

IUPAC Name:

benzyl(diethylamino)diphenylphosphanium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]benzen-1-olate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Addotto GM 102 E/BAF 1/1
- description: white powder
- batch: 14334/56
- storage conditions: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Luciano Conelli Arona (NO) Italy
- Age at study initiation: 2-3 months
- Weight at study initiation:2.8-2.9 kg
- Housing: individual caging in air conditioned rooms
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: about 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Air changes (per hr): 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

Dosage: 0.1 g/animal
Administration route: ocular

Duration of treatment / exposure:

single administration

Observation period (in vivo):

at 1, 24, 48 and 72 hrs after the test article application.
After the 24 hrs reading the cornea were examined after instillation of one drop of 1% sodium fluorescein and subsequent washing out with sterile saline. Further observation were done at 7 and 14 days after treatment.

Number of animals or in vitro replicates:

3 males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hrs

Score:

1

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 48, 72 hrs

Score:

0

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 hrs

Score:

2

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 48, 72 hrs

Score:

0

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24 hr

Score:

2

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 48 hr

Score:

1

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 72 hr

Score:

0

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hr

Score:

1

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48, 72 hr

Score:

0

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 hr

Score:

2

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 48 hr

Score:

1

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72 hr

Score:

0

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24 hr

Score:

2

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 48, 72 hr

Score:

1

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 7 days

Score:

1

Any other information on results incl. tables

No animals died.

No signs of systemic toxicity were seen in any animal. Locally the test compound induced marked lacrimation in two out of the three animals starting 24 hrs after treatment. One of these rabbits (no.3) still showed this change at the following observation performed at 48 and 72 hrs or 7 days from the start of the test; at this latter reading time the lacrimation was evaluated as moderate. In addition in the above animals whitish material in the conjunctival fornix was found at the 24 and 48 hrs readings.

Eye evaluation:

Cornea

the direct examination of the cornea performed 60 mins after treatment showed diffuse slight opacity in all the animals which was no longer observed. At the examination carried out after instillation of one drop of 1% sodium fluorescein, performed 24 hrs after test starting, no signs suggestive of epithelial defects were noted in any animal.

Iris

No signs were noted at any time.

Conjunctivae

slight signs of ocular irritancy were seen in all the animals starting 1 hr after treatment. At the following reading time (24 hrs) and increase in degree of the above signs up to score 2 was noted in 2 animals, while in the remaining rabbit they mantained a constant value. 48 hrs reading showed complete regression of any sign of ocular irritancy in one animal. At this time, in the remaining rabbits, slight redness of the conjunctivae was seen, this finding was also associated in one of them with slight conjunctival swelling.

At the following examinations performed 72 hrs and 7 days from treatment, in one animal only signs of ocular irritancy, consistend with slight conjunctival redness were still evident.

14 -days examination did not reveal any change.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The individual scoring of the irritation observed was under the labelling threshold for ocular irritation as dictated in Regulation no. 1272/2008/EC and therefore the test substance should be considered not irritant following this Directive.

Executive summary:

Experimental data obtained from an acute eye irritation study after a single administration of 0.1 g of the test article Addotto GM 102/E BAF 1/1 in the New Zealand White rabbit (3 animals) are given in this endpoint.

No signs of systemic toxicity were seen in any animal. Marked lacrimation and whitish material in the conjunctival fornix were seen in two of the three animals starting 24 hrs after treatment. In one rabbit lacrimation continued up to 7 days.

Locally the test compound induced, on the whole, slight signs of ocular irritancy in all the animals consistent with corneal opacity, redness and chemosis of the conjunctivae already starting from the 1st observation performed (1 hr).

24 hrs reading showed signs of conjunctival irritancy (redness and chemosis) which continued in one case only up two remaining animals between 48 and 72 hrs from test starting.