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

Skin irritation / corrosion

Administrative data

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)

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

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

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Any other information on results incl. tables

No animal died.

No clinical signs or behavioral alterations were noted.

No dermal modifications were observed in any animal.

Applicant's summary and conclusion

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.