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

Endpoint summary

Description of key information

In order to test the irritant/corrosive properties for skin and eyes of the substance, an in vivo skin irritation study and an in vivo eye irritation study were performed. The studies were performed under GLP conditions  and according to OECD GLP in the testing of chemicals [C(81)30 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.
Basing on the results of the studies, the test substance was classified according to the REGULATION (EC) No 1272/2008  as following:
Skin corrosion/irritation: not classified
Hazard statement: none
Serious eye damage/ eye irritation: not classified
Hazard statement: none.

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:

January 16 to 19, 1990

Reliability:

1 (reliable without restriction)

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Luciano Conelli Arona (NO) Italy
- Age at study initiation: 2-3 months
- Weight at study initiation:2-3 kg
- Housing: individual caging in air conditioned rooms
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: about 5 weeks

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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

physiological saline

Controls:

other: untreated skin of each animal

Amount / concentration applied:

Dosage: 0.5 g/animal
Administration route: epidermal
Exposure time: 4 hours

Duration of treatment / exposure:

Single administration

Observation period:

ar 1, 24, 48 and 72 hours after patch removal

Number of animals:

3 males

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

No animal died.

No clinical signs or behavioral alterations were noted.

No dermal modifications were observed in any animal.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

At the application site no dermal reactions were detected in any rabbit.
The test article GM 102 E/BAF 1/1, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered NON IRRITANT for the skin.

Executive summary:

Experimental data obtained from an acute dermal irritation study after a single administration of 0.5 g/animal of the test article in the New Zealand White rabbit (3 animals) are given in this endpoint. No deaths occurred as a result of treatment, nor were observed untoward clinical signs or behavioral alterations.

At the application site no dermal reactions were detected in any rabbit.

The test article GM 102 E/BAF 1/1, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered NON IRRITANT for the skin.

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:

January 23 to February 6, 1990

Reliability:

1 (reliable without restriction)

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

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hrs

Score:

1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 48, 72 hrs

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 hrs

Score:

2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 48, 72 hrs

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24 hr

Score:

2

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 48 hr

Score:

1

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 72 hr

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hr

Score:

1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48, 72 hr

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 hr

Score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 48 hr

Score:

1

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72 hr

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24 hr

Score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 48, 72 hr

Score:

1

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 7 days

Score:

1

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In the skin irritation study, the irritation potential was investigated following administration of a single dose of 0.5 g/animal in the New Zealand White rabbit. No mortality and no dermal reactions were detected in any rabbit.

These results indicate that the test item, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered NON IRRITANT for the skin.

In the eye irritation study, the irritation potential was investigated following administration of a single dose of 0.1 g/animal in the New Zealand White rabbit (3 animals). No signs of systemic toxicity were seen in any animal.

24 hour reading showed signs of conjunctival irritancy (redness and chemosis) which continued in one case only up to 7 days, disappearance of the above changes being recorded for the two remaining animals between 48 and 72 hours from test starting.

The substance induce reversible eye irritation, when applied to the eye of animal; for each tested animal, the mean scores following grading at 24, 48 and 72 hours after installation of the test material, is under the labelling threshold for ocular irritation as dictated in Regulation no. 1272/2008/EC .

Justification for selection of skin irritation / corrosion endpoint:
One study available

Justification for selection of eye irritation endpoint:
One study available

Justification for classification or non-classification

Basing on the results above reported, REGULATION (EC) No 1272/2008 ( EU Regulation on Classification, Labelling and Packaging of substances and mixtures) would indicates the following:

 

Classification

Skin corrosion/irritation: Not classified

Hazard statement: none

 

Serious eye damage/ eye irritation: none

Hazard statement: none