triphenyl(((1r,4r)-4-((E)-prop-1-en-1-yl)cyclohexyl)methyl)phosphonium iodide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to the OECD guideline 404 and in compliance with GLP. The substance used for read across (Triphenyl-(4-vinyl)cyclohexyl-methylphospohniumiodid, D 6) is structurally very similar to the registered substance Triphenyl-(4-propenyl)cyclohexyl-methylphosphoniumiodid (E 6). The only difference concerns the length of side chain in para position of the hexylring being a vinyl group for D 6 and a propenyl group for E 6. Therefore a read-across from D 6 to E 6 is considered reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1171067-76-1

IUPAC Name:

1171067-76-1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2795-2995 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-21°C°C
- Humidity (%): 40-50%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control site at the same animal (0.5 ml Tylose MH 1000)

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

0.5 g of the test item were moistened with a 0.5 % (m/v) solution of Tylose MH 1000 in deionised water, applied to the shaved skin area
(approx. 2 x 3 cm) and covered with one layer of a gaze patch (2.5 x 3.5 cm). It was covered with aluminium foil (3 x 4 cm) which was held
in contact with the skin by occlusive dressing (Elastoplast, Beiersdorf AG). A gauze patch moistened with 0.5 ml of a 0.5 % (m/v) solution of
Tylose MH 1000 in deionised water was applied to the control area in the same manner.
After an exposure period of 4 hours the patch was removed and the administration area was cleaned with deionised water without altering the
integrity of the epidermis.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1-2

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal: 1-2

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

The administration of 0.5 g of D6 to shaved dorsal area of the trunk of albino rabbits did not cause any irritations of the skin on the administration
areas.

Other effects:

No systemic toxic effects were observed. None of the animals died during the course of investigation and no clinical stgns were observed.
Necropsy was not carried out, because no clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In accordance with the results of this study and in compliance with the criteria of Appendix 6 to Directive 2001/59/EU of August 06, 2001 D6 may
be classified as a substance that is nonirritant to the skin.