Amides, coco, N,N-bis(hydroxyethyl); C10-12 and C18-unsatd. DEA

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 01, 1986 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:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

Cas Number:

90622-74-5

Molecular formula:

The alkyl chain length of the amide ranges between 12 and 18 carbon atoms.

IUPAC Name:

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

Constituent 2

Reference substance name:

2,2'-iminodiethanol

EC Number:

203-868-0

EC Name:

2,2'-iminodiethanol

Cas Number:

111-42-2

Molecular formula:

C4H11NO2

IUPAC Name:

2-(2-hydroxyethylamino)ethanol

Test material form:

liquid

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: 2,192 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:

mean

Time point:

24/48/72 h

Score:

3.96

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

3.12

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

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

Results table:

Product	Animal number	Hours after the plaster removal										Days after the plaster removal
		immediate		1		24		48		72		7		10		14		17		21
		E	O	E	O	E	O	E	O	E	O	E	O	E	O	E	O	E	O	E	O	N	S
ke 421 left side	339	3	2	4	2	4	4	4	4	4	4	4	2	4	2	4	0	4	0	4	0	N	S	Na
	342	4	2	4	2	4	4	4	4	4	4	4	2	4	2	4	0	4	0	4	0	N	S
	352	4	2	4	2	4	4	4	4	4	4	4	2	4	2	4	2	4	2	4	0	N	S
	355	4	2	4	2	4	4	4	4	4	4	4	2	4	3	4	2	4	1	4	0	N	S
	369	4	2	4	2	4	4	4	3	4	3	4	2	4	2	1	0	0	0	0	0	S	Na
	X	5.8		6		8		7.8		7.8		6		6.2		4.2		3.8		3.2
	X%	72.5		75		100		97.5		97.5		75		77.5		52.5		47.5		40
Right side	339	1	0	2	0	3	2	4	3	4	3	3	2	3	2	1	0	0	0	0	0
	342	1	1	2	1	3	2	3	3	4	3	4	2	3	2	1	0	0	0	0	0	Sx
	352	1	1	1	1	3	1	4	3	4	3	2	2	2	2	0	0	0	0	0	0	Sx
	355	2	1	2	1	3	2	3	3	4	3	2	1	1	0	0	0	0	0	0	0	Sx
	369	2	1	1	1	3	2	4	3	4	4	1	0	1	0	0	0	0	0	0	0	Sx
	X	2.2		2.4		4.8		6.6		7.2		3.8		3.2		0.4		0		0
	X%	27.5		30		60		82.5		90		47.5		40		5		0		0

E = Erythema

O = Odema

N = Necrotic skin change

S = Scab

Sx = Punctiform scraps

Na = Scar

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant) based on CLP criteria

Conclusions:

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

Executive summary:

A study was conducted to assess the skin irritation potential of test substance, C12-18 and C18 -unsatd. DEA, to rabbit skin according to OECD Guideline 404. In this study, 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 for 21 d after patch removal and scored according to the Draize system. 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 test conditions, test substance was considered to be irritating to rabbit skin (Kästner, 1986).