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Toxicological information

Skin sensitisation

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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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A study using a non-LLNA protocol already exists.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethoxypropoxy Propanol
- Substance type: Glycol ether
- Physical state: Colourless liquid
- Lot/batch No.: GOHC Ref 1030, Oil stocks 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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
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)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
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

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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.

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.