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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study design (OECD 406 and EU Method B.6), but with no positive control group.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
EU Method B.6 (Skin Sensitization)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A reliable existing GPMT study is already available.
Species:
guinea pig
Strain:
other: Hartley / Dunkin
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Each animal was identified by ear tattoo
- Source: D. Hall, Newchurch, Staffordshire, England
- Weight at study initiation: 370 to 490 g
- Housing: Animals were housed in suspended cages with wire mesh floors.
- Diet: Ad libitum access to Vitamin C-enriched Guinea-Pig Diet F.D.1 (Special Diets Services Limited). Hay was provided once weekly.
- Water: Ad libitum access to tap water.
- Acclimation period: Animals selected for study were acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature: Animal room temperature was approximately 21 degrees C.
- Humidity: Animal room relative humidity was 30 – 70%.
- Air changes: Approximately 15 changes per hour
- Photoperiod: 12 hours of artificial light in each 24 hour period

IN-LIFE DATES: From: 13 August 1985 To: 9 September, 1985
Route:
intradermal and epicutaneous
Vehicle:
other: Liquid paraffin
Concentration / amount:
Induction (intradermal injection) – 7.5% v/v in liquid paraffin, and 7.5% in a 50:50 mixture of Freund’s complete adjuvant and liquid paraffin
Induction (topical) – undiluted
Challenge (topical) – 50% and 20% v/v in liquid paraffin
Route:
epicutaneous, occlusive
Vehicle:
other: Liquid paraffin
Concentration / amount:
Induction (intradermal injection) – 7.5% v/v in liquid paraffin, and 7.5% in a 50:50 mixture of Freund’s complete adjuvant and liquid paraffin
Induction (topical) – undiluted
Challenge (topical) – 50% and 20% v/v in liquid paraffin
No. of animals per dose:
20 (test group)
10 (controls)
Details on study design:
RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of ethoxypropyl acetate in liquid paraffin was investigated to identify a) irritant test substance concentrations suitable for the induction phase of the main study and b) non-irritant concentrations by the topical route of administration for the challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Intradermal injections – Three pairs (left and right side of interscapular region) of injections:
1) Freund’s complete adjuvant (Difco laboratories, Detroit, MI) diluted with an equal volume of water
2) Ethoxypropyl acetate, 7.5% v/v in liquid paraffin
3) Ethoxypropyl acetate, 7.5% v/v in a 50:50 mixture of FCA and liquid paraffin

Topical application – One week after injections in the same interscapular area. A 2 x 4 cm patch of Whatman No. 3 paper was saturated with ethoxypropyl acetate as supplied. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape (5 cm width “Blenderm”). This in turn was firmly secured by elastic adhesive bandage (“Elastoplast” 5 cm width) wound round the torso of the animal and fixed with “Sleek” impervious plastic adhesive tape.
- Exposure period: Topical application was left in place for 48 hours.
- Control group: The control animals were treated similarly to the test animals with the exception that the test substance was omitted.

B. CHALLENGE EXPOSURE
- No. of exposures: A single challenge exposure
- Day(s) of challenge: 2 weeks after the induction exposures
- Exposure period: 24 hours
- Test groups: A 2 x 2 cm patch of Whatman No. 3 paper was saturated with approximately 0.2 ml of ethoxypropyl acetate, 50% v/v in liquid paraffin and applied to an anterior site on the flank. Ethoxypropyl acetate, 20% in liquid paraffin was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours under strips of “Blenderm” covered by “Elastoplast” wound round the trunk and secured with “Sleek”.
- Control group: Treated similarly to the test group.
- Evaluation (hr after challenge): Challenge sites were evaluated 24, 48 and 72 hours after removal of the patches. Sites were scored for erythema and eschar formation (Grade 0 – 4) and oedema (Grade 0 – 4). A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and / or persistent than the maximum reaction seen in animals of the control group.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in liquid paraffin
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: 50% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in liquid paraffin
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: 50% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50% in liquid paraffin
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0.

One control animal was found in poor condition and euthanized during the induction period. All challenges with 20% in liquid paraffin also produced no reaction in any animal at any time point.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on these results, the study authors concluded that ethoxypropyl acetate did not produce any evidence of delayed contact hypersensitivity.
Executive summary:

In a guideline and GLP skin sensitization study using the guinea pig maximization protocol, ethoxypropyl acetate did not induce delayed contact hypersensitivity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Guinea pig maximisation study: negative

Justification for classification or non-classification

Ethoxypropyl acetate is not a skin sensitizer in guinea pigs. There is no data to indicate that there is any potential to cause respiratory sensitisation.