Phosphoric acid, mono- and di-C16-18-alkyl esters

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May to July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Octadecyl dihydrogen phosphate

EC Number:

220-983-1

EC Name:

Octadecyl dihydrogen phosphate

Cas Number:

2958-09-0

Molecular formula:

C18H39O4P

IUPAC Name:

octadecyl dihydrogen phosphate

Constituent 2

Reference substance name:

Hexadecyl dihydrogen phosphate

EC Number:

222-581-1

EC Name:

Hexadecyl dihydrogen phosphate

Cas Number:

3539-43-3

Molecular formula:

C16H35O4P

IUPAC Name:

hexadecyl dihydrogen phosphate

Constituent 3

Reference substance name:

Dioctadecyl hydrogen phosphate

EC Number:

221-237-8

EC Name:

Dioctadecyl hydrogen phosphate

Cas Number:

3037-89-6

Molecular formula:

C36H75O4P

IUPAC Name:

dioctadecyl hydrogen phosphate

Constituent 4

Reference substance name:

Dihexadecyl hydrogen phosphate

EC Number:

218-594-7

EC Name:

Dihexadecyl hydrogen phosphate

Cas Number:

2197-63-9

Molecular formula:

C32H67O4P

IUPAC Name:

dihexadecyl hydrogen phosphate

Constituent 5

Reference substance name:

hexadecyl octadecyl hydrogen phosphate

Cas Number:

93803-11-3

Molecular formula:

C34H71O4P

IUPAC Name:

hexadecyl octadecyl hydrogen phosphate

impurity 1

Reference substance name:

Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.

Molecular formula:

N/A

IUPAC Name:

Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.

Test material form:

solid

Details on test material:

CAS Number 39471-52-8

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Animals were nulliparious and non-pregnant
At lease 5 days of acclimatisation provided
Weight: 15 to 23 g
Age: 8 to 12 weeks old
Animals individually housed in solid floor suspended cages.
Free access to food and tap water available for the animals.
The temperature and humidity were controlled to remain within the range 19 - 25ºC and 30 to 70% respectively.

Study design: in vivo (LLNA)

Vehicle:

other: Butanone

Concentration:

25ul of solution with a concentration of 10, 5 & 2.5% w/w in butanone.

No. of animals per dose:

Four.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

The positive control (85%) was considered to be a sensitiser under the conditions of the test.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.99

Test group / Remarks:

2.5%

Results 2

Parameter:

SI

Value:

1.45

Test group / Remarks:

5%

Results 3

Parameter:

SI

Value:

2.66

Test group / Remarks:

10%

Any other information on results incl. tables

Study completed at good quality European Union (EU) laboratory according to OECD Guideline 429 (Local Lymph node assay) and according to GLP. The Skin sensitization study determined that the test material was found to be a non-sensitizer under the conditions of the test.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not sensitising.