ColaLiquids DC5, DL, DM (Commercial names)Cocamide DIPA (INCI name)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Repeat insult patch testing but In-use study

Deviations:

not applicable

Principles of method if other than guideline:

One hundred four women participated in an in-use study to determine the safety and efficacy of a shampoo containing 2% Cocamide DEA. Each panelist was patch tested on the upper arm with 2% aqueous shampoo, containnig other typical shampoo ingredients (preservative 15ppm and fragrance 5% in oil). The three occlusive patches were applied and scored for irritation 48 h later at the time of patch removal.
The subjects were then instructed to shampoo daily with the test product for 87 days.
Ten days after the final use of the shampoo, challenge patches were administered following the same procedure as the initial patches except the preservative concentration was increased to 50 ppm
and an additional scoring for reactions was made 24 h after patch removal. No reactions were observed to the preservative or fragrance patches.
Eleven subjects reacted to the 2% shampoo initial patch; eight had mild erythema (l+scores on a O-4 scale), one had intense erythema (2+), and two subjects had erythema and edema (3+). Twenty-four subjects had irritation scores of 1 + (18/24), 2+ (3/24), and 3+ (3/24) 48 h after challenge patch application of the shampoo. Thirty subjects had 1 + (25/30) or 2 + (5/30) irritation scores at the second
challenge reading.
All reactions were considered to be irritant in nature. The shampoo was an irritant but not a sensitizer.

GLP compliance:

not specified

Remarks:

data taken from a CIR review paper. Full details are not disclosed and the test was 1983 so GLP not necessarily required at that time.

Type of study:

patch test

Justification for non-LLNA method:

Because adequate data from an in vivo skin sensitisation study are available.

Test material

Test material information

Constituent 1

Reference substance name:

Amides, coco, N,N-bis(hydroxyethyl)

EC Number:

271-657-0

EC Name:

Amides, coco, N,N-bis(hydroxyethyl)

Cas Number:

68603-42-9

Molecular formula:

C16H33NO

IUPAC Name:

N,N-Bis(2-hydroxyethyl)dodecanamide

Specific details on test material used for the study:

2% patched as 2% aqueous solution, used full strength for 87 days

In vivo test system

Test animals

Species:

other: human

Sex:

female

Results and discussion

In vivo (non-LLNA)

Results

Key result

Reading:

other: observations on human use

Hours after challenge:

240

Group:

test chemical

Dose level:

2%

No. with + reactions:

11

Total no. in group:

104

Clinical observations:

Eleven subjects reacted to the 2% shampoo initial patch; eight had mild erythema (l+ scores on a O-4 scale), one had intense erythema (2+), and two subjects had erythema and edema (3+). All reactions were considered to be irritant in nature

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the animal and clinical data assessed, the CIR Expert Panel concluded that Cocamide DEA is safe as used in rinse-off products and safe at concentrations ~10% in leave-on cosmetic products. Cocamide DEA should not be used as an ingredient in cosmetic products in which N-nitroso compounds are formed.