3,5,8-Trioxa-4-phosphaundec-10-en-1-aminium, 4-hydroxy-N,N,N,10-tetramethyl-9-oxo-, inner salt, 4-oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: Letter of Access (See Section 13)

Adequacy of study:

key study

Data source

Reference

Reference Type:

other: Letter of Access (See Section 13)

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

not specified

Remarks:

Letter of Access Only

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

417-560-0

EC Name:

-

Cas Number:

67881-98-5

Molecular formula:

C11H22NO6P

IUPAC Name:

trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

None available: Letter of Access only

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

no

Amount / concentration applied:

500 mg of HEMA-PC was applied to each animal.

Duration of treatment / exposure:

4 hours

Observation period:

The observation period was 14 days after exposure.

Number of animals:

3 animals were tested

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean value

Time point:

other: 24 - 72 hours

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean value

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean value

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean value

Time point:

other: 24 - 72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 96 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean value

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

Refer to Table 1.

Any other information on results incl. tables

Table 1. Overall Results (showing mean scores for 3 animals): Calculated on the basis of the scores for each animal at 24, 48 and 72 hours.

	Animal	Mean Score	Maximum Value	Maximum Duration of any Effect	Maximum value at the end of the observation period
Erythema/eschar	1 2 3	1 0 0	1	7 days	0
edema	1 2 3	0.67 0 0	1	96 hours	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results of this study indicate that HEMA-PC is not irritating to the skin.

Executive summary:

This study was conducted to determine if HEMA-PC was irritating to the skin following OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation Corrosion).

The results of this study indicate that HEMA-PC is not irritating to the skin.