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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In a primary dermal irritation study 6 female albino rabbits were dermally exposed to C12-18 alkyldimethyl ammonium chloride (75% in water/isopropanol) for 4 h under occlusive conditions on intact and abraded skin. Animals then were observed for 24 h.
GLP compliance:
no
Remarks:
test conducted before implementation of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: aqueous solution

Test animals

Species:
rabbit
Strain:
other: albine strain, no further specification
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually in screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one side clipped, one side clipped + abraded
Vehicle:
unchanged (no vehicle)
Observation period:
24 h
Number of animals:
6
Details on study design:
TEST SITE
The test material was applied under a 1 x 1 inch 12 ply gauze patch held in place by 1/2 inch adhesive tape applied as an "X" over the patch. The trunk of the animals was then loosely wrapped in an impervious wrap for an exposure period of 4 hours. The wrap was applied loosely enough for the palm of the hand to be inserted between it and the animals back.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

OBSERVATION TIME POINTS
2, 4, 24 hours

SCORING SYSTEM:
- Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1-#6
Time point:
24 h
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
effects were classified as corrosive; no further observation after 24 h
Irritation parameter:
edema score
Basis:
animal: #1-#6
Time point:
24 h
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
effects were classified as corrosive; no further observation after 24 h
Irritation parameter:
erythema score
Remarks:
abraded and intact sites
Basis:
animal: #1-6
Time point:
other: 2 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded and intact sites
Basis:
animal: #1-6
Time point:
other: 2 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded and intact sites
Basis:
animal: #1-6
Time point:
other: 4 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded and intact sites
Basis:
animal: #1-6
Time point:
other: 4 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: #1-6
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
not measured/tested
Remarks:
no observation after 24 h; thus, no mean can be calculated
Irritation parameter:
edema score
Basis:
animal: #1-6
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
not measured/tested
Remarks:
no observation after 24 h; thus, no mean can be calculated
Irritant / corrosive response data:
Irreversible damage to the skin classifies the material as corrosive (effects are not described in detail in the study report).

Any other information on results incl. tables

Score at time point / Reversibility

Erythema – intact skin site

Edema – intact skin site

Erythema – abraded skin site

Edema – abraded skin site

Max. score: 4

Max. score: 4

Max. score: 4

Max. score: 4

2 h

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

4 h

2/2/2/2/2/2 

2/2/2/2/2/2 

2/2/2/2/2/2 

2/2/2/2/2/2 

24 h

c/c/c/c/c/c 

c/c/c/c/c/c 

c/c/c/c/c/c 

c/c/c/c/c/c 

 

C = Irreversible damage to the skin classifies the material as corrosive.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Under the conditions of the test, Di-C12-18 alkyldimethyl ammonium chloride (75% in water/isopropanol) is corrosive to the skin.
Executive summary:

In a primary dermal irritation study conducted before implementation of GLP and OECD guidelines 6 female albino rabbits were dermally exposed to Di-C12-18 alkyldimethyl ammonium chloride (75% in water/isopropanol) for 4 h under occlusive conditions on intact and abraded skin. Animals then were observed for 24 h. Irritation was scored by the Draize scale.

After 2 h, no skin reactions were observed. After 4 hours, erythema and edema scores were 2 in all animals on intact an abraded skin sites. After 24 h, skin reactions are described as corrosive (irreversible damage) without further specification in the study report.