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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(p-isocyanatophenyl) thiophosphate
EC Number:
223-981-9
EC Name:
Tris(p-isocyanatophenyl) thiophosphate
Cas Number:
4151-51-3
Molecular formula:
C21H12N3O6PS
IUPAC Name:
O,O,O-tris-(4-isocyanatophenyl) thiophosphate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl:HA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratory, Kißlegg, Germany
- Age at study initiation: approx. 4-5 weeeks
- Weight at study initiation: 275-371 g
- Diet and water: ad libitum
- Acclimation period: at least 5 days

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: methyl ethyl ketone (MEK)
Concentration / amount:
1st to 3rd induction: 100% test substance (undiluted)
1st challenge: 50% test substance (in MEK)
2nd challenge: 25% (in MEK)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: methyl ethyl ketone (MEK)
Concentration / amount:
1st to 3rd induction: 100% test substance (undiluted)
1st challenge: 50% test substance (in MEK)
2nd challenge: 25% (in MEK)
No. of animals per dose:
experimental group: 20
control group: 10
Details on study design:
RANGE FINDING TESTS:
Range finding tests for induction were performed using 5 females.
- for induction: 0.5 ml of 0%, 25%, 50% and 100% of the test item in MEK were applied occlusively to the skin for 6 hours. No signs of irritation occured.
Range finding tests for challenge were performed using 2 animals which were treated in the same manner als the control animals during induction.
- for challenge: 0.5 ml of 0%, 25%, 50% and 100% of the test item in MEK were applied occlusively to the skin for 6 hours. No signs of irritation occured.

MAIN STUDY
A. INDUCTION EXPOSURE
- the animals were treated with the test item three times at intervals of seven days. The suitable areas of the body were shaved one day (24 hours) before each treatment. The volume applied per animal was 0.5 m on a hypoallergic patch and held in place on the skin with 'ORABAND' adhesive plaster. Six hours after treatment the patches were removed and any remaining test item was washed off the skin with physiological saline solution. Treatment areas were vusally assessed 30 hours after initiation of exposure.


B. CHALLENGE EXPOSURE
- First challenge: the animals were treated with the test item four weeks after the first (two weeks after the last) dermal induction. Backs and right flanks were shaved one day (24 hours) before challenge. The test item (50% in MEK) applied per animal was 0.5 m on a hypoallergic patch and held in place on the right flank with 'ORABAND' adhesive plaster. Six hours after treatment the patches were removed and any remaining test item was washed off the skin with physiological saline solution. 24 hours later the treatment areas were shorn.
- Second challenge: the second challenge was performed one week after the 1st challenge with 0.5 ml of a 25% test item formulation in MEK in the same way with the exception that the left flank of the animals were shorn and the patches were applied to the left flank.
Skin reactions were assessed 30 hours after initiation of the induction exposures, and 30 and 54 hours after the beginning of the challenge.

OTHER:
In addition to the skin reactions the following data were recorded: Mortality/ Clinical signs once daily; Body weights prior to start , on day 30 and at termination of the study.
Challenge controls:
As a control a patch loaded only with the vehicle was applied and fixed also to the right flank, cranial to the test item patch.
Positive control substance(s):
yes
Remarks:
Reliability check of Buehler test with alpha-hexylcinnamicaldehyde revealed a sensitization rate of 100% (test substance concentration 40% for induction and 20% for challenge).

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: first challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
6
Total no. in group:
17
Remarks on result:
other: Reading: other: first challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 6.0. Total no. in groups: 17.0.
Reading:
other: first challenge
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: other: first challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
other: second challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
17
Remarks on result:
other: Reading: other: second challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 17.0.
Reading:
other: second challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
17
Remarks on result:
other: Reading: other: second challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 17.0.
Reading:
other: second challenge
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: second challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

The animals in the test item group and in the control group showed no clinical signs of toxicity. Three animals of the test item group died (two on day 11 and one on day 12).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

A skin sensitization test according to OECD guideline 406 (Buehler Patch Test) was conducted on female guinea pigs with the neat test substance (27% of tris(p-isocyanatophenyl) thiophosphate in ethyl acetate) for dermal induction. For challenge test concentrations of 50% (1st challenge) and 25% (2nd challenge) formulated in methyl ethyl ketone were applied. 24 and 48 hours after challenge exposure the treated sites were assessed. The first challenge let to skin effects (grade 1) in 6 of 17 animals (35%) in the test item group and in 7 of 10 animals (70%) of the control group. The second challenge with 25% test item did not induce skin effects at all. Under the conditions tested the test item exhibits no skin sensitization potential.