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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

key study

Study period:

January 23 - February 22, 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)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.

GLP compliance:

not specified

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Description: white powder
Batch: 14334/56
Purity: > 99%
Storage conditions: at room temperature

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

Body weight: between 432 - 570 grams at the start of the experimet (corresponding to 2-3 months old)
Acclimatation: at least five days. Animals were observed daily to ascertain their fitness for the study.
Housing: 5 animals/cage in air conditioned room. Temperature: 22°C+/-2; air changes: about 12 h; relative humidity: 60% +/-2; light: 12 hours cycle
Animal identification: by coloring different area of the ears. A computerized randomization program was adopted to allocate the animals to groups.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: ethanol.

Induction 2

Concentration / amount:

175 mg/animal for each application.
The test article was diluted w/v in ethanol to obtain 35% test article concentration.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: ethanol.

Challenge 2

Concentration / amount:

175 mg/animal for each application.
The test article was diluted w/v in ethanol to obtain 35% test article concentration.

No. of animals per dose:

23 animals
10 animals/group
3 animals for the preliminary test

Results and discussion

Any other information on results incl. tables

Skin sensitization test in guinea pigs (Buhler test)

Body weight (grams)

Group n.	Guinea pig n.	Days
		0	7	14	28
1	1	488	522	558	586
	2	458	489	541	629
	3	570	616	687	623
	4	515	559	615	609
	5	478	522	583	675
	6	520	535	589	585
	7	482	488	524	657
	8	525	565	627	634
	9	488	518	543	722
	10	501	528	575	651
2	11	480	523	546	670
	12	432	501	548	649
	13	510	557	618	665
	14	513	551	600	706
	15	432	470	482	498
	16	459	518	544	620
	17	550	607	662	770
	18	496	532	559	620
	19	482	525	591	681
	20	525	558	610	713

Skin sensitization test in guinea pigs (Buhler test)

Experimental group N. 1

	Challenge
	Test article	Vehicle	Test article	Vehicle
Days	29		30
Guinea pig n.
1	0	0	0	0
2	0	0	0	0
3	0	0	0	0
4	0	0	0	0
5	0	0	0	0
6	0	0	0	0
7	0	0	0	0
8	0	0	0	0
9	0	0	0.5	0
10	0	0	0	0

0: No reaction

Animals showing reaction > 1 were considered positive. N. of positive animals at the challenge: 0

Results: NEGATIVE

Skin sensitization test in guinea pigs (Buhler test)

Experimental group N. 2

Substance: ethanol

	Challenge
	Test article	Vehicle	Test article	Vehicle
Days	29		30
Guinea pig n.
11	0	0	0	0
12	0	0	0	0
13	0	0	0	0
14	0	0	0	0
15	0	0	0	0
16	0	0	0	0
17	0	0	0	0
18	0	0	0	0
19	0	0	0	0
20	0	0	0	0

 

0: No reaction

Animals showing reaction > 1 were considered positive. N. of positive animals at the challenge: 0

Results: NEGATIVE

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The sensitizing potential of the test article was assessed in guinea pigs using the Buhler test. No animal trated with the test article showed positive reaction at the challenge.
On the basis of these results, under the experimental conditions applied, the test item did not appear to possess sensitizing capacity.