Isopentyl phenethyl ether

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 march to 11 May 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The in vivo guinea pig maximisation test was already available (performed in 1982) and reliable to evaluate the skin sensitization potential and the classification determination.

Test material

Test material information

Constituent 1

Reference substance name:

Isopentyl phenethyl ether

EC Number:

259-943-3

EC Name:

Isopentyl phenethyl ether

Cas Number:

56011-02-0

Molecular formula:

C13H20O

IUPAC Name:

isopentyl phenethyl ether

Specific details on test material used for the study:

Test material name (as stated in the report): ANTHER
Appearance: Clear colourless liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

Ten guinea pigs weighing about 320 g are selected

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: Freund's complete adjuvant

Concentration / amount:

(i) two 0.1 ml injections of 50% Freund's complete adjuvant (FCA) in the solvent chosen for the test substance.
(ii) two 0.1 ml injections of test substance at the concentration selected for induction from the preliminary irritation test.
(iii) two 0.1 ml injections of test substance in solvent mixed 50/50 with FCA such that final concentration of the test substance injected is the same that in (ii) above

Induction 2

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

undiluted, piece of thin polythene is saturated with test substance

Day(s)/duration:

48 hours

Challenge

Challenge 1

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

patch test is saturated with the test substance

Day(s)/duration:

24 hours

Challenge 2

No.:

#2

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

patch test is saturated with the test substance

Day(s)/duration:

24 hours

No. of animals per dose:

1 animal per dose

Challenge controls:

treated and untreated controls

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Neat

No. with + reactions:

5

Total no. in group:

10

Clinical observations:

Faint erythema to moderate erythema

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Neat

No. with + reactions:

3

Total no. in group:

10

Clinical observations:

Faint erythema to moderate erythema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The Anther was considered to be not skin sensitizer according to this test. It can be concluded from the test results that the test substance ANTHER does not meet the criteria to be classified according to the CLP Regulation 1272/2008/EC.

Executive summary:

The Anther was examined for skin sensitization potential in this Guinea Pig skin sensitisation test dated on 11 May 1982, performed at Unilever research Laboratory.

Intradermal injection for induction

The hair is clipped from a 2 x 4 cm area of skin in the dorsal shoulder region and 3 pairs of intradermal injections made within the shaved areas

(i) two 0.1 ml injections of 50% Freund's complete adjuvant (FCA) in the solvent chosen for the test substance. (ii) two 0.1 ml injections of test substance at the concentration selected for induction from the preliminary irritation test. (iii) two 0.1 ml injections of test substance in solvent mixed 50/50 with FCA such that final concentration of the test substance injected is the same that in (ii) above

Topical application for induction

One week after the injections the same 2 x 4 cm area is clipped and shaved. A 2 x 4 cm filter paper patch attached by double-sided adhesive tape to a 4 x 6 cm piece of thin polythene, is saturated with the test substance and placed over the shaved site. The patch is held in place for 48 hours by adhesive plaster wrapped around the trunk behind the fore limbs.

Challenge

Thirteen to 14 days after the application of the induction patch the guinea pigs are challenged on the clipped and shaved flank by occluded patch. For each animal an 8 mm diameter filter paper patch in an 11 mm aluminium patch test cup is saturated with test substance at the selected challenge concentration and the patch applied to the shaved flank. The patch is held in place for 24 hours by adhesive plaster wound around the trunk. The treatment site are examined for evidence of sensitization 24, 48 hours after removal of the patches.

One week after the 1st challenge a second challenge is made on the opposite flank exactly as for the 1st challenge.

The Anther was considered to be not skin sensitizer according to this test. It can be concluded from the test results that the test substance ANTHER does not meet the criteria to be classified according to the CLP Regulation 1272/2008/EC.