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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 25 - April 9, 1993

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

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:

Batch: 14334/56
Purity: 95%
Storage conditions: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Number and sex:
5 males + 5 female/group
Body weight:
Males: 225-250 g; Females: 200- 225 g
Age:
7 - 9 weeks
Acclimition:
5 days before the start of the test. Animals were observed daily to ascertain their fitness for the study.
Housing:
individual caging in air-conditioned rooms. Temperature: 22°C+/-2; Relative humidity: 55%+/-10; Air changes: about 20/hour filtered on HEPA 99.97%; Light: 12 hour cycle

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

Administration route: epidermal
Reason for selection of administration route: possible accidental exposure for humans
Administration frequency: single
Observation period: 14 days after the administration
Preparation of animals skin: approximately 24 hours before the test, for was clipped from the dorsal and ventral area of the trunk of the test animals. Care was taken to avoid abrading the skin which could alter its permeability. An area of about 6x5cm of the body dorsal surface was cleared for the application of the test article. This area corresponding to about 10% of the total body surface.
Administration of the test article: by uniform application onto the cleared area. The treated area was covered with a porous gauze deressing fixed to the skin with hypoallergenic non irritating tape. The test side was further covered in a suitable manner in order to ensure that the animals could not ingest the test substance. At the end of the exposure period the residual test substance was wiped off.

Duration of exposure:

24 hours

Doses:

one group of 5rat/sex administered a single dose of 2000 mg/kg (limit dose).

No. of animals per sex per dose:

5 males + 5 female/group

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the observation period.

Clinical signs:

other: No general clinical signs were noticed. Erythema and crusts of the skin were observed at the application site of some rats starting from day 2- 3 and lasting up to days 4 - 7 of the study.

Gross pathology:

Animals killed at the end of the observation period
No changes were observed in the animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The test article Addotto GM 102 E/BAF 1/1, when administered by dermal route to rat, under the conditions adopted in this experiment, did not cause mortality at the limit dose of 2000 mg/kg.
The LD50 by dermal route is higher than 2000 mg/kg.
Local reversible irritation changes were the only signs observed.