Propanol, (2-ethoxymethylethoxy)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study - original study report available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A study using a non-LLNA protocol already exists.

Test material

Test material information

Constituent 1

Reference substance name:

5-methyl-4,7-dioxa-2-nonanol

Cas Number:

58797-30-1

Molecular formula:

C8H18O3

IUPAC Name:

5-methyl-4,7-dioxa-2-nonanol

Constituent 2

Reference substance name:

1-(2-ethoxypropoxy)propan-2-ol

EC Number:

233-408-4

EC Name:

1-(2-ethoxypropoxy)propan-2-ol

Cas Number:

10143-32-5

Molecular formula:

C8H18O3

IUPAC Name:

6-methyl-4,7-dioxa-2-nonanol

Details on test material:

- Name of test material (as cited in study report): Dipropylene Glycol Monoethyl Ether
- Substance type: Glycol ether
- Physical state: Clear, colourless liquid
- Lot/batch No.: GOHC Lab. sample No. 1030, Oil Stocks reference No. 08977, 134/109
- Storage condition of test material: Ambient temperature in brown screw cap bottle
- Other:

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Porcellus Animal Breeding Ltd, Sussex, UK
- Weight at study initiation: 314-391g
- Housing: Open top with solid floors
- Diet (e.g. ad libitum): Pelleted feed ad libitum
- Water (e.g. ad libitum): mains supply.
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (15-23)
- Humidity (%): 55%
- Air changes (per hr): 17 without re-circulation
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 1985-09-24 to 1985-10-26

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

1,3, 10, 30, 70 and 100% in water (2 animals) or 1, 2, 4, 8, 15 and 25% in Freund's Complete Adjuvant in 2 animals in primary irritation screen
3, 10, 30 and 100% epicutaneously with occlusion (first phase) and 30, 50, 80 and 100% (second phase)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

1,3, 10, 30, 70 and 100% in water (2 animals) or 1, 2, 4, 8, 15 and 25% in Freund's Complete Adjuvant in 2 animals in primary irritation screen
3, 10, 30 and 100% epicutaneously with occlusion (first phase) and 30, 50, 80 and 100% (second phase)

No. of animals per dose:

2

Details on study design:

RANGE FINDING TESTS:
Primary skin irritation screen tested DGMEE at 1,3, 10, 30, 70 and 100% in water (2 animals) or 1, 2, 4, 8, 15 and 25% in Freund's Complete Adjuvant in 2 animals in primary irritation.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs on same animal
- Exposure period: Evaluated at 24 and 48 hrs after exposure.
- Test groups: 0.1 ml intradermally at 10% in distilled water (middle sites); 4% in Freund's Complete Adjuvant (posterior s
- Control group: Freund's Complete Adjuvant alone (Anterior sites)
- Site:
- Frequency of applications: once
- Duration: 24 and 48 hr
- Concentrations:

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hr
- Test groups: 0.025 ml each of 50%, 80% or 100% DGMEE
- Control group: not mentioned
- Site: Shaved flanks
- Concentrations: 50%, 80% or 100% DGMEE
- Evaluation (hr after challenge): 24 and 48

Challenge controls:

Challenged as in treatment groups

Positive control substance(s):

no

Results and discussion

Positive control results:

A positive control was not used in this study.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

20

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

20

Results 5

Group:

positive control

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

A positive test result is recorded when more than one of the test group animals exhibit erythema or dermal swelling 24 or 48 hours after removal of
the bandages following challenge with a sub-irritant concentration of test material. There were no erythematous reactions at any test site examined
24 or 48 hours after challenge.

Executive summary:

Repeated administration of dipropylene glycol monoethyl ether failed to induce delayed contact hypersensitivity in guinea-pigs.