Fatty acids, C8-16, 2-ethylhexyl esters

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1998-06-29 to 1998-07-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study in accordance with generally accepted scientific standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

The test substances was applied at concentrations of 25%, 50% and 100% to 20 healthy volunteers in an occlusive patch test for 24 h. Texapon N25 (1%), SDS (0.5%), Aqua dest. and Paraffin perliquid were used as controls. The volunteers were subsequently investigated for skin irritation for up to 72 h after exposition.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-16(even numbered), 2-ethylhexyl esters

EC Number:

603-931-6

Cas Number:

135800-37-2

Molecular formula:

C16H32O2 to C24H48O2

IUPAC Name:

Fatty acids, C8-16(even numbered), 2-ethylhexyl esters

Details on test material:

- Name of test material (as cited in study report): 2-Ethyl-hexylester with fatty acids C8/14
- Analytical purity: no data

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 20
- Sex: male and female
- Age: between 21 and 56 years (Mean 32.95 y)

Ethical approval:

not specified

Route of exposure:

dermal

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

concentrations of 25%, 50% and 100% under occlusive conditions for 24 h.

Medical treatment:

No

Results and discussion

Clinical signs:

The test substance caused no effects at concentrations of 25% and 50%. The undiluted (100%) substance mainly resulted in light and transient erythema. Only one well-defined erythema and 3 cases of edema were detected.
The positive controls resulted in slight to strong erythema and slight edema formation (SDS and Texapon) in 6 and 17 volunteers, respectively, supporting the sensitivity and reliability of the test method.

Results of examinations:

The test substance was considered to possess very good skin compatibility at 25% and 50% dilutions and good skin compatibility as undiluted substance.

Effectivity of medical treatment:

Not applicable

Outcome of incidence:

Not applicable

Any other information on results incl. tables

Number of reactions for the parameters erythema, edema desquamation and fissures differentiated according to the strength.

Substance	Without reaction	Erythema				Edema				Desquamation				Fissures
		1	2	3	4	1	2	3	4	1	2	3	4	1	2	3
Test substance (25%)	20/20	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Test substance (50%)	20/20	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Test substance (100%)	13/20	13	3	-	-	-	-	-	-	1	-	-	-	-	-	-
Parrafin perliquid	19/20	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Phys. NaCl	18/20	4	-	-	-	1	-	-	-	-	-	-	-	-	-	-
Aqua demi.	18/20	3	-	-	-	-	-	-	-	-	-	-	-	-	-	-
SDS (0.5%)	14/20	26	15	2	-	12	-	-	-	3	-	-	-	-	-	-
Texapon N25 1%	3/20	31	10	-	-	15	-	-	-	-	-	-	-	-	-	-

1: Slight reaction

2: Medium reaction

3: Strong reaction

4: Very strong reaction

-: No reaction

Reactions for the parameters erythema, edema desquamation and fissures added up.

Substance	Erythema (total/mean)	Edema (total/mean)	Desquamation (total/mean)	Fissures (total/mean)	Sum of all effects (total/mean)
Test substance (25%)	0/0	0/0	0/0	0/0	0/0
Test substance (50%)	0/0	0/0	0/0	0/0	0/0
Test substance (100%)	19/0.95	1/0.05	0/0	0/0	20/1
Parrafin perliquid	1/0.05	0/0	0/0	0/0	1/0.05
Phys. NaCl	4/0.2	0/0	1/0.05	0/0	5/0.25
Aqua demi.	3/0.15	0/0	0/0	0/0	3/0.15
SDS (0.5%)	62/3.1	3/0.15	12/0.6	0/0	77/3.85
Texapon N25 1%	51/2.55	0/0	15/0.75	0/0	66/3.3