3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been performed equivalent to OECD 404 guideline. Non GLP. Observation period was limited to directly and 48 hours after patch removal.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation period was limited to directly and 48 hours after patch removal. Limited details on animals and environmental conditions.

GLP compliance:

no

Remarks:

not present at the time of performance.

Test material

Test material information

Constituent 1

Reference substance name:

3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene

EC Number:

255-138-6

EC Name:

3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene

Cas Number:

40910-49-4

Molecular formula:

C14H26O2

IUPAC Name:

1-[(3,7-dimethylocta-1,6-dien-3-yl)oxy]-1-ethoxyethane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Elintaal F
- Description: Clear colourless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Adult animals

ENVIRONMENTAL CONDITIONS
No data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

12

Details on study design:

STUDY DESIGN
The test substance is brought on the intact or abraded skin under a surgical patch measuring 2.54 x 2.54 cm.

TEST SITE
Twenty four hours prior to applying the material, the hair is removed from the back of the animal with an electric clipper in such a way as to avoid abrasions.
Six rabbits are treated on the intact skin, the other on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.

REMOVAL OF TEST SUBSTANCE
Twenty four hours after the application, the dressing was removed.

The skin reactions were assessed directly (first reading) and 48 hours (second reading) after the removal of the dressings and test substance.

SCORING SYSTEM:
The irritation at the first reading was assessed according to the numerical scoring system according to OECD 404.
The second reading is carried out on the basis of the CIVO-grading system:
0 = no reaction at all
1 = very slight scaliness
2 = distinct scaliness or very slight incrustation
3 = distinct incrustation
4 = secere incrustation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: erythema, edema and scaliness

Basis:

mean

Remarks:

animal #1, #2, #3, #4 and #6

Time point:

other: 48 hours

Score:

2

Max. score:

4

Remarks on result:

other: score intact skin

Results 2

Irritation parameter:

other: erythema, edema and scaliness

Basis:

animal #5

Time point:

other: 48 hours

Score:

1

Max. score:

4

Remarks on result:

other: score intact skin

Results 3

Irritation parameter:

other: erythema, edema and scaliness

Basis:

mean

Remarks:

animal #7, #8, #9, #10, #11 and #12

Time point:

other: 48 hours

Score:

2

Max. score:

4

Remarks on result:

other: score abraded skin

Irritant / corrosive response data:

Elintaal F caused moderate skin irritation. Its dermal effects consisted of very slight or well-defined erythema, very slight ischemia, slight or distinct scaliness and very slight or slight edema.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline, irritation was observed.

Executive summary:

Elintaal F was tested in a skin irritation study with rabbits, performed equivalent to OECD 404 test guideline.

Elintaal F caused moderate skin irritation 48 hours after patch removal. Its dermal effects consisted of very slight or well-defined erythema, very slight ischemia, slight or distinct scaliness and very slight or slight edema.

As the observation period was limited to 48 hours after patch removal and no reversibility has been observed, Elintaal F should be classified as skin irritation cat.2 and should be labelled with H315: Causes skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.