Propane-1,2-diol, propoxylated

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diol, propoxylated

EC Number:

500-039-8

EC Name:

Propane-1,2-diol, propoxylated

Cas Number:

25322-69-4

Molecular formula:

(C3 H6 O)n H2 O n= >1 - <4.5

IUPAC Name:

propane-1,2-diol, propoxylated

Details on test material:

Name: Propane-1,2-diol propoxylated
Molecular weight: Mn = 260 g/mole
Physical state: clear, colourless, slightly viscous liquid
Composition of test material, percentage of components: Propylene oxide - 100%
Lot number: T103APR02
Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS: Mouse
- Strain: CBA/Ca
- Sex: female
- Source: B&K Universal Ltd, Hull, UK
- Age: 7-12 weeks
- Weight at study initiation: 15-23 g
- Number of animals: 20
- Controls: Solvent and positive controls

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

0.5, 5 and 50%

No. of animals per dose:

5

Details on study design:

ADMINISTRATION/EXPOSURE
- Study type: Local lymph node assay
- Preparation of test substance for induction: In acetone/olive oil 4:1
- Induction schedule: Daily application of 25 ul of the test solution to the dorsal surface of each ear for 3 consecutive days.
- Assessment procedure: After 2 days without treatment the mice were injected in the tail vein with 3H-methyl thymidine and after 5 hours the draining auricular lymph nodes were excised and processed for each individual animal.
- Concentrations used for induction: 0.5, 5 and 50%
- Positive control: A summary of positive control data (non-current) which indicated that the assay used produced a positive response was provided. The positive controls included hexyl cinnamic aldehyde.

EXAMINATIONS
- Assessment system: The incorporation of 3H-methyl thymidine was measured by beta-scintillation counting as disintegrations per minute (DPM) using a Beckman LS6500 scintillation system and reported as a stimulation index (the ratio of 3HTdR incorporation into lymph node celss relative to controls).
- Evaluation criteria: The test is considered positive if at least one concentration results in >= threefold increase in 3HTdR incorporation compared to controls

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: A stimulation index (SI) of less than 3 was recorded for all test concentrations. 0.5%: SI 1.00, 5% : SI 0.60 and 50% : SI 1.40.

Any other information on results incl. tables

Clinical signs: There were no deaths or clinical signs of intoxication.  Body weights were comparable between test and control groups.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Propane-1,2-diol propoxylated (molecular weight 230) was considered to be a non-sensitiser under the conditions of this local lymph node assay.