Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Details on test animals and environmental conditions
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2500-3500 gram
- Housing: animals were housed individually in suspended, galvanized cages, fitted with wired-mesh
floor and front
- Diet: standard laboratory rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3 ºC
- Humidity (%): 40 to 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: not reported

Test system

Type of coverage:
other: both occlusive and non-occlusive application
Preparation of test site:
other: both intact and abraded skin after clipping
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL of undiluted test material
Duration of treatment / exposure:
4 h
Observation period:
4, 28, 52 and 76 h after application of test substance
Number of animals:
6 per exposure group
Details on study design:
TEST SITE
- Area of exposure: 1x1 inch for occlusive expousre
- % coverage:
- Type of wrap if used: surgical patch fixed with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: test substance was removed after 4 h, method not specified
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 4, 28, 52 and 76 h after initial exposure
SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
open test
Basis:
mean
Time point:
other: 4 and 52 hours
Score:
2.4
Reversibility:
fully reversible within: 20 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
closed patch test
Basis:
mean
Time point:
other: 4 and 52 hours
Score:
4.2
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
Open test - intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
Open test - abraded skin
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not specified

Any other information on results incl. tables

ER = erythema; ED = oedema

Open test - abraded skin

   4 h  28 h  52 h  76 h
 Rabbit no.

 ER-ED

ER-ED

ER-ED

ER-ED

 3418  2-1  2-1 2-2   2-1
 3419  2-0  1-1  4-1  1-0
 3420  1-0  1-0  4-1  1-1
 3421  1-0  1-1  1-1  1-1
 3422  2-0  1-0  4-0  1-0
 3423  1-0  2-1  2-2  4-1
 average  1.7 2.0 4.0   2.3

Open test - intact skin

   4 h  28 h  52 h  76 h
 Rabbit no.

 ER-ED

ER-ED

ER-ED

ER-ED

 3418

2-0

 2-1

 2-2

 2-1

 3419

 1-0

1-0 

 1-1

 1-1

 3420  1-0  1-0  2-1  1-1
 3421  2-0  1-1  1-1  1-0
 3422  1-0  1-0  1-0  1-1
 3423  1-0  1-1  3-1  4-1
 average  1.3  1.7  2.7  2.5

Closed patch test - abraded skin

   4 h  28 h  52 h  76 h
 Rabbit no.

 ER-ED

ER-ED

ER-ED

ER-ED

 3418  4-1  4-1  4-2  2-1
 3419  4-2  4-2  4-2  4-2
 3420  4-1  4-2  4-2  4-1
 3421  4-1  4-2  4-2  4-2
 3422  2-1  2-1  2-1  2-1
 3423 1-1   2-1  3-2  4-1
   4.3 4.8  5.3  4.7 

Closed patch test - intact skin

   4 h  28 h  52 h  76 h
 Rabbit no.

 ER-ED

ER-ED

ER-ED

ER-ED

 3418  1-0  4-1  4-2  2-1
 3419  1-1  2-1  2-2  2-1
 3420  4-1  4-1  4-1  1-1
 3421  1-1 2-1   3-2  4-2
 3422 1-1   2-1  2-1  2-1
 3423  1-1  2-1  3-2  4-1
 average  2.3  3.7  4.7  3.7

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
On the basis of the results obtained and the primary irritation indices calculated it is concluded that the undiluted test substance is a moderate primary skin irritant, both in case of 4 hours contact with the open, non-occluded, rabbit skin and in the case of 4 hours contact with the occluded rabbit skin.
Furthermore, it appeared that the test substance caused more severe irritation of the skin in the closed patch test than in the open test.
Executive summary:

The test substance was examined undiluted for primary skin irritation properties in a 4 -hour open test and in a 4 -hour closed patch test with six albino rabbits.

The dermal effects generally observed in both tests consisted of very slight or well-defined erytheme, very slight or slight oedema, very slight or slight incrustation, and slight or slight to moderate scaliness.

In addition, slight haemorraghes were obsrebed in the closed patch test. The dermal effects observed in the closed patch test were more severe than those observed in the open test.

The primary irritation indices were calculated to be 2.4 (open test) and 4.2 (closed patch test).

On the basis of the results obtained and the primary irritation indices calculated it was concluded that the undiluted test substance is a moderate primary skin irritant, both in case of 4 hours contact with the open, non-occluded, rabbit skin and in the case of 4 hours contact with the occluded rabbit skin.

Furthermore, it appeared that the test substance caused more severe irritation of the skin in the closed patch test than in the open test.