Amides, vegetable-oil, N,N-bis(hydroxyethyl)

Endpoint summary

Description of key information

Skin Irritation

Oleamide DEA CAS 93 -83 -4

Two groups of six New Zealand rabbits were used to evaluate the skin irritancy of . Each animal received a single 24-h occlusive patch containing 0.3 ml test material. Test sites were scored for erythema, eschar formation, and edema 1 and 48 h after patch removal. One group was given 70% Oleamide DEA in propylene glycol, and the other group received 5% Oleamide DEA in propylene glycol.

Linoleamide DEA CAS 5686 -02 -6

Undiluted Linoleamide DEA was evaluated for sensitization using 102 individuals

in an RIPT. Ten 48-h occlusive induction patches were followed, after a 2-week nontreatment period, by a single 48-h occlusive challenge patch. No reactions

were observed to any induction or challenge patch.Linoleamide DEA was not an irritant or sensitizer.

Other information in WOE approach. SourceFinal Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA . Author CIR

JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 5, Number 5, 1986 Mary Ann Liebert, Inc., Publishers. Peer reviewed..

Lauramide DEA CAS 120 -40 -1

Four groups of six guinea pigs were used to evaluate the skin irritation and percutaneous toxicity of 0.5% (w/v) aqueous Lauramide DEA. The same immersion test procedure was used for all four groups of animals: the guinea pigs were clipped free of abdominal hair, then immersed up to the axillae in the test solution 4 h/day for 3 consecutive days. The test solutions were kept at 4O”C, and animals were weighed before the first immersion and 48 h after the final immersion. All but one animal gained weight (3-23 g) during the tests. Forty-eight hours after the third immersion, the skin of the abdomen was graded on a \l (moribund due to skin injuries) to 10 (normal) scale. Six animals had scores of 7 (slight “scurfing” over the entire skin, slight loss of elasticity), 12/24 animals had scores of 8 (moderate scaling, no loss of elasticity), and 6/24 animals had scores of 9 (first hint of scaling). Lauramide DEA in 0.5% aqueous solution was a mild skin irritant. No controls were included in these tests. Lauramide DEA was evaluated for skin irritation in another four groups of six guinea pigs in immersion tests using the l-10 scoring scale. Two groups were immersed in 0.25% aqueous Lauramide DEA 4 h/day for 3 consecutive days; this concentration of Lauramide DEA was minimally irritating. The animals had skin irritation scores of 8 (4112 animals), 9 (5/10), and 10 (3/12).(“.“) The other two groups of guinea pigs were immersed in 0.1% aqueous Lauramide DEA following the same schedule of immersion. The immersion scores (nine grade 9 and three grade 10) indicated that 0.1% Lauramide DEA was a minimal skin irritant (80.81) ‘A noncoloring shampoo containing 8% Lauramide DEA and a bubble bath containing 6% Lauramide DEA were minimal skin irritants under the test conditions of the guinea pig immersion test. Both products were tested at 0.5% (w/v) in water. Animal scores for the shampoo assay were 8 (2/6 animals), 9 (2/6), and 10 (2/6).The bubble bath was even less irritating than the shampoo, with four guinea pigs having a skin grade of 9 and two having a grade of 10.

Linoleamide DEA CAS 5686 -02 -6

Linoleamide DEA was evaluated for dermal irritation and toxicity in six guinea pig immersion tests all following the same protocol. Six animals were immersed in the test solution 4 h/day for 3 consecutive days. Animals were weighed before the first immersion and 48 h after the third immersion. The shaved area of the abdomen was scored for irritation at the same time the final weights were taken. Irritation was graded on a l-l 0 scale as described above, with 10 denoting no irritation. The results of the six assays were: 0.5% aqueous Linoleamide DEA was a slight irritant in one assay with animal scores of 8 and gts4); 0.5% aqueous Linoleamide DEA was a minimal irritant in a second assay, with one animal having a score of 8 and the remaining animals having no irritation’ 85); 0.5% aqueous Linoleamide DEA was nonirritating in a third assay and all animals had skin irritation scores of 10 (*6); 0.25% aqueous Linoleamide DEA was a slight skin irritant-three animals had skin grades of 7 and the other three guinea pigs had skin grades of 9 w’)* 0.1% aqueous Linoleamide DEA was a minimal irritant with animal scores of 9’ and 10'; a product containing 1.5% Linoleamide DEA was a slight skin irritant when tested as a 0.5% aqueous solution. A skin grade of 7 was observed for two animals, grade 8 for three animals, and the last animal had a skin grade of 9.

Eye Irritation

Oleamide DEA CAS 93 -83 -4

Undiluted Oleamide DEA was applied in a 0.1 ml dose to the left eye of three albino rabbits, and the right eye served as an untreated control. Eyes were not rinsed, and the maximum Draize score recorded was 2 for conjunctival irritation. No irritation was observed by Day 2. Undiluted Oleamide DEA was practically nonirritating under these test conditions.

Linoleamide DEA CAS 5686 -02 -6

Six albino rabbits received 0.1 ml Linoleamide DEA in one eye, and the untreated contralateral eye was used as the control. Draize scores for irritation were 34 on Day 1, 27 on Day 2, 26 on Day 3, 18 on Day 4, and 13 on Day 7. These scores were the average of the six individual animals’ scores.

Other information in WOE approach. SourceFinal Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA . Author CIR

JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 5, Number 5, 1986 Mary Ann Liebert, Inc., Publishers. Peer reviewed..

Cocamide DEA CAS 68603 -42 -9

Thirty percent Cocamide DEA in propylene glycol was tested for ocular irritation in three female rabbits. A single 0.1 ml aliquot of the solution was instilled into the conjunctival sac of the rabbits’ left eyes, and the untreated right eyes served as controls. Eyes were examined for irritation and inflammation of the iris, cornea, and conjunctiva 1 h after instillation and daily thereafter up to a maximum of 7 days. The Draize scoring system for eye irritation was used.(56) Only maximum scores for the one hour and day three readings were reported. The irritation scores for the iris and cornea were 0, and the maximum conjunctival score was 6 at 1 h and 4 at Day 3. All eyes were normal by Day 4. The cumulative ocular irritation rating was not reported, but 30% Cocamide DEA was at least a mild eye irritant.ts

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

XXX