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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other:
Version / remarks:
Section 173.240 (a) (1) Ti t l e 49 C F R
Principles of method if other than guideline:
Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

In vitro test system

Control samples:
no

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol.
Duration of treatment / exposure:
4h
Observation period:
4h/24h/72h
Number of animals:
6
Details on study design:
Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Intact Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.83
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Intact Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.83
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Abraded Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Abraded Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Abraded Skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Intact Skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Imtact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
7
Reversibility:
not specified
Remarks on result:
other: Abraded skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits.
A single 4 h, occluded application of the test material to the skin of 6 rabbits produced no erythema or edema. 24 and 72 h observation showed minimal, barely perceptible erythema and no edema.
Executive summary:

75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits. A single 4 h, occluded application of the test material to the skin of 6 rabbits produced no erythema or edema. 24 and 72 h observation showed minimal, barely perceptible erythema and no edema.