3-[3-hydroxypropyl(2-methylpropyl)phosphoryl]propan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 2003- March2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 429 (Skin Sensitisation: Local Lymph Node Assay)

Version / remarks:

2002

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:

-

EC Number:

464-510-9

EC Name:

-

Cas Number:

147768-39-6

Molecular formula:

C10H23O3P

IUPAC Name:

3-[(3-hydroxypropyl)(2-methylpropyl)phosphoryl]propan-1-ol

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

Female CBA/Ca (CBA/CaBkl) strain mice were supplied by B & K Universal Ltd, Hull, UK. The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

Groups of five mice were treated with the undiluted test material or the test material at
concentrations of 25% or 50% v/v in dimethyl formamide.

No. of animals per dose:

5

Details on study design:

Information available suggested that
the test material would not produce systemic toxicity or excessive local irritation at the highest
suitable concentration. The mice were treated by daily application of 25 μl of the appropriate
concentration of the test material to the dorsal surface of each ear for three consecutive days
(Days 1, 2, 3 ). The test material formulation was administered using an automatic micropipette
and spread over the dorsal surface of the ear using the tip of the pipette.

Results and discussion

Positive control results:

a-HEXYLCINNAMALDEHYDE : Three groups, each of five animals, were treated with 50 μl (25 μl per ear) of a-HEXYLCINNAMALDEHYDE as a solution in acetone/olive oil 4: 1 at concentrations of 5%, 10% and 25% v/v. A further control group of five animals was treated with acetone/olive oil 4: 1 alone.
SI were determined as being 1.49, 1.73 and 5.26 respectively for 5, 10 and 25% (%v/v) in the vehicle

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1.24

Test group / Remarks:

25% in vehicle

Results 2

Key result

Parameter:

SI

Value:

1.42

Test group / Remarks:

50% in vehicle

Results 3

Key result

Parameter:

SI

Value:

1.46

Test group / Remarks:

100%

Cellular proliferation data / Observations:

The results of the statistical analysis of the data indicated there was no significant difference between the control group and the test groups.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A stimulation index of less than 3 was recorded for the undiluted test material and the 50% and 25% v/v concentrations of the test material. The test material was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

The test item is not considered to be a skin sensitizer.