Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January to February 18, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Method B.6 (Skin Sensitization)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)

EC Number:

931-335-9

Molecular formula:

not applicable

IUPAC Name:

Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

other: Kleinrusse Chbb

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HM/Fa. Thomae, Germany
- Average weight at study initiation: 2192 g

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Undiluted

Duration of treatment / exposure:

4 h

Observation period:

21 d

Number of animals:

5

Details on study design:

24 h before test start, the right flank of the rabbits was shaved and the skin inspected for intactness. Only rabbits with intact skin were used for the study. 0.5 mL of the undiluted test substance were applied to a 2.5 x 2.5 cm patch and placed onto the shaved skin, then securely fastened with a larger plastic sheet to provide an occlusive dressing. After 4 h, the dressing was removed and the skin was scored for reddening (erythema) and swelling (oedema) after 1, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d according to the Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.8

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.8

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3.8

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.16

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 9

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3.16

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

Light to moderate erythema and light oedema were observed on the treated skin after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the study conditions, the test substance was considered to be irritating to rabbit skin.

Executive summary:

A study was conducted to assess the skin irritation potential of the test substance, C12-18 and C18-unsatd. DEA, to rabbit skin according to OECD Guideline 404 and EU Method B.6, in compliance with GLP. The shaved skin of 5 rabbits was exposed to the undiluted test substance using occlusive patches for 4 h. The skin was then observed for effects (scoring according to the Draize system) for 21 d after patch removal. Exposure to undiluted test substance caused light to moderate erythema and light oedema immediately after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d. Under the study conditions, the test substance was considered to be irritating to rabbit skin (Kästner, 1986).