Fatty acids, C16-18, sodium salts

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Type of study / information:

Identity of test material same as for substance defined in section 1 (if not read-across)

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

according to guideline

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Edenor C16 92/94

IUPAC Name:

Edenor C16 92/94

Constituent 2

Reference substance name:

Edenor Ti dest. (fatty acid C 16 - 18 + 18')

IUPAC Name:

Edenor Ti dest. (fatty acid C 16 - 18 + 18')

Details on test material:

The following substances were investigated for skin irritatlon:
1 = Lorol, technisch (Fettalkohol C12 - 18) - FA010
2 = Lorol RG, neutral (Fettalkohol dest. Rückstand) - FA015
3 = Lorol RG, alkalisch (Fettalkohol dest. Rtickstand) - FA015
4 = Edenor C 12 98/100 (Fettsäure C 12) - FS004
5 = Edenor C 16 92/94 (Fettsäure C 16) - FS008
6 = Edenor Ti dest. (Fettsäure C 16 - 18 + 18') - FSOlO
7 = Polyresidal N (Ruckstand gesättige Fettsäuren) - FS016
8 = Polyresidal F (Rtickstand ungesättigte Fettsäuren) - FSOl7
9 = Edenor ME C 6 - 10 (Fettsäuremethylester C 8) - FSMEOOl
10 = Edenor ME Ti 05 F (Fettsauremethylester C 14 - 18 + 16' - 18') - FSMEOO5
11 = Edenor ME Palm (Fettsäuremethylester C: Palm) - FSME013
12 = Edenor ME Rückst. I1 (Fettsäuremethylester dest. Rückstand) - BSME 016
13 = Ke 491 (FS8 - 10 + TMPr + NPG) - ESTOOl
14 = Eden01 B 35 (FE18EPO) + 2/6 Guer) - ESTOO2
15 = Triacetin - GLYOOl
16 = Magnesiumsilikat - SNS004

Method

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

The test method was the closed epicutaneous application of the method described in Frosch (Finn Chamber assay, modified Duhring-chamber test was selected). 70 μl of the test substances were applied once for a period of 24 hours on the skin of the back, using a Large Finn Chamber on Scanpor . After removal of the patch the skin were observed after 1, 6, 24, 48, 72 and 144 hours.
The following parameters were evaluated:
- erythema
- edema
- dandruff
- formation of fissures
At the examination 20 voluntary healthy female and male subjects with an age of 21-50 (mean: 31.95) have participated.

Exposure assessment:

measured

Details on exposure:

The test method was the closed epicutaneous application of the method described in Frosch (Finn Chamber assay, modified Duhring-chamber test was selected). 70 μl of the test substances were applied once for a period of 24 hours on the skin of the back, using a Large Finn Chamber on Scanpor . After removal of the patch the skin were observed after 1, 6, 24, 48, 72 and 144 hours.
The following parameters were evaluated:
- erythema
- edema
- dandruff
- formation of fissures

Results and discussion

Results:

Edenor C 16, Ti Edenor dist. and Edenor ME Rückstand II were tolerated by all subjects without responses. Lorol RG neutral, Lorol RG alkalisch, Polyresidal N, Polyresidal F, Ti Edenor ME 05 F, Edenor ME Palm, Ke 491, Edenol B 35 and Magnesiumsllikat caused only slight erythema in individual cases.
Lorol technisch and Triacetin caused only slight erythema, but slightly more common than the above-mentioned substances.
Edenor C 12 and C Edenor ME 60-10 caused slight edema, slight dandruff and light to medium, very occasionally more erythema.
All test chemicals were below the 1% irritation potential of the internal standard substance Texapon N 25.

Any other information on results incl. tables

Calculating the irritation scores in percent relative to the control Texpapon N 25 (100%)     erythema erythema, edema, dandruff, formation of fissures Texapon N 25 100.00 100.00 Lorol, technisch 11.70 10.38 Lorol RG, neutral 1.06 0.94 Lorol RG, alkalisch 3.19 2.83 Edenor C 12 69.15 72.60 Edenor C 16 0.00 0.00 Edenor Ti dest. 0.00 0.00 Polyresidal N 1.06 0.94 Polyresidal F 1.06 0.94 Edenor ME C 6 – 10 57.45 54.72 Edenor ME Ti 05 F 3.19 2.83 Edenor ME Palm 2.13 1.89 Edenor ME Rückst. II 0.00 0.00 Ke 491 1.06 0.94 Edenol B 35 1.06 0.94 Triacetin 12.77 11.32 Magnesiumsilikat 3.19 2.83 Paraffinöl 0.00 0.00 Aqua dest. 1.06 0.94 phys. NaCl 5.32 4.72

Applicant's summary and conclusion

Conclusions:

Edenor C 16 92/94 - FS008 and Edenor Ti dest. (Fettsäure C 16 - 18 + 18') - FSOlO were tolerated by all subjects without responses. So the substances possess a very good skin compatibility.

Executive summary:

The following substances were investigated for skin irritation in 20 healthy volunteers in a closed epicutaneous test: 1 = Lorol, technisch (Fettalkohol C12 - 18) - FA010 2 = Lorol RG, neutral (Fettalkohol dest. Rückstand) - FA015 3 = Lorol RG, alkalisch (Fettalkohol dest. Rtickstand) - FA015 4 = Edenor C 12 98/100 (Fettsäure C 12) - FS004 5 = Edenor C 16 92/94 (Fettsäure C 16) - FS008 6 = Edenor Ti dest. (Fettsäure C 16 - 18 + 18') - FSOlO 7 = Polyresidal N (Rückstand gesättige Fettsäuren) - FS016 8 = Polyresidal F (Rtückstand ungesättigte Fettsäuren) - FSOl7 9 = Edenor ME C 6 - 10 (Fettsäuremethylester C 8) - FSMEOOl 10 = Edenor ME Ti 05 F (Fettsauremethylester C 14 - 18 + 16' - 18') - FSME005 11 = Edenor ME Palm (Fettsäuremethylester C: Palm) - FSME013 12 = Edenor ME Rückst. II (Fettsäuremethylester dest. Rückstand) - FSME 016 13 = Ke 491 (FS8 - 10 + TMPr + NPG) - EST00l 14 = Eden01 B 35 (FE18EPO) + 2/6 Guer) - EST002 15 = Triacetin - GLY00l 16 = Magnesiumsilikat - SNS004 A concentration of 50 % was used. The test substances were applied for 24 hours. There were only slight reactions, except Edenor C 12 and Edenor ME C 6 - 10, which caused little stronger reactions. The irritation index of the test substances was generally lower than that of the internal standard 1 % Texapon N 25. Edenor C 12 and Edenor ME C 6 - 10 are considered to possess a sufficient skin compatibility while the other substances are considered to possess a good to very good skin compatibility.