[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data are given; pre-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

2 animals; treatment time: 1, 5, 15 min, 20 h; observation after 24 hours and 8 days

Principles of method if other than guideline:

Before OECD TG 404 was established in 1984, skin irritation was tested using an internal method (BASF Test).

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate

EC Number:

212-028-2

EC Name:

[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate

Cas Number:

751-83-7

Molecular formula:

C33H38P.HO4S

IUPAC Name:

mono[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium hydrogensulphate

Details on test material:

- Name of test material (as cited in study report): C15-Salz, i.e. beta-ionylidene ethyl-triphenylphosphonium hydrogensulphate, solid
- Analytical purity: no data
No further data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

no further data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 50% aqueous suspension

Duration of treatment / exposure:

1 min, 5 min, 15 min (short-term test)
20 h (long-term test)

Observation period:

8 days

Number of animals:

2 animals (short-term test)
2 animals (long-term test)

Details on study design:

TEST SITE
- Area of exposure: back and ear
An application site of 2.5 cm x 2.5 cm was covered with the test substance. In addition, skin tissue from the ear was tested. These results from the ear were not taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back as required by current Testing Guidelines.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: at the end of the respective exposure times
At the end of the respective application time (i.e. 1 min, 5 min, 15 min , 20 h), the sites were wiped with water containing a mild detergent.
SCORING SYSTEM: BASF scoring system, convertible to Draize score

The animals were observed for 7-8 days and skin changes were recorded on working days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

20-hour exposure

Basis:

mean

Remarks:

of n=2

Time point:

other: 24 hours - 8 days

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis observed; skin not evaluable at 8 d

Results 2

Irritation parameter:

edema score

Remarks:

20-hour exposure

Basis:

mean

Remarks:

of n=2

Time point:

other: 24 hours - 8 days

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis observed; skin not evaluable at 8 d

Results 3

Irritation parameter:

erythema score

Remarks:

exposure for 1, 5, 15 min

Basis:

mean

Remarks:

of n=2

Time point:

other: 24 hours - 8 days

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis observed

Results 4

Irritation parameter:

edema score

Remarks:

exposure for 1, 5, 15 min

Basis:

mean

Remarks:

of n=2

Time point:

other: 24 hours - 8 days

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis or desquamation observed

Irritant / corrosive response data:

Animals exhibited erythema grade 1-2 and signs of necrosis already 24 h after removal of the patches. These lesions were not reversible within 8 days.
Partially, the scores for erythema and edema at the treated skin sites could not be evaluated because of this necrosis. Therefore, an irritation index was not calculated; the skin irritation was classified based on the necrosis findings.
For details, see table below.

Any other information on results incl. tables

Table: skin findings (erythema and edema scores converted to Draize system); mean scores (mean of n = 2)

Application site	Exposure time	Findings after
		24 hours			8 days
		erythema	edema	other findings, remarks	erythema	edema	other findings, remarks
back	1 min	1	1	spotted erythema	0	0	desquamation
	5 min	1	1		*	*	focal necrosis
	15 min	* 1 **	* 2 **	superficial necrosis	*	*	focal necrosis, margins sclerotic
back	20 h	* 1 **	* 1 **	superficial necrosis	*	*	focal necrosis margins sclerotic
ear	20 h	1	1	discharge	*	*	superficial necrosis

*: application site: not evaluable, due to necrosis

**: findings at the margins of necrosis

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test substance was classified as corrosive (Cat. 1), based on necrosis observed after exposure for 5 minutes.