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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
Study period:
March 6, 1992 - December 23, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NBDI
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach (6 males)
- Age at study initiation: no data
- Weight at study initiation: 2.25 kg +/- 0.172
- Housing: Building F-3, Rabbits per steel wire cage: 1
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- degrees Celsius
- Humidity (%): 45-65%
- Air changes (per hr): 12-15 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: July 28, 1992 To: August 19, 1992

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.5 mL
VEHICLE: Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 (2x3 cm gauze patch)
- Type of wrap if used: wrapping of gauze which was secured and semioccluded by a wrapping of fixomull.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: After a 4-hour exposure period wrappings were removed and the substance was washed away with water

SCORING SYSTEM: According to the method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 14 days in all animals.
Other effects:
The skin reactions increased up to 24 hours. After about 10 days, the upper layers of the skin fell off and the skin underneath was visible. It showed a beat red, shiny surface, which was about to heal.

Any other information on results incl. tables

Macroscopic findings during necropsy:

Animal No.

Pathol. No.

Necropsy day

Macroscopic finding

1

150/92

14

Treated skin severely red (beat red)

2

151/92

14

Treated skin red and scabby

3

152/92

14

Treated skin red and scabby

4

153/92

14

Treated skin red and scabby (petechiae in the underneath subcutaneous tissue)

5

154/92

14

Treated skin red and scabby (petechiae in the underneath subcutaneous tissue)

6

155/92

14

Treated skin red, scabby and ruptured

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive)
Conclusions:
Based on the results of an in vivo skin irritation test performed according to OECD guideline 404, NBDI is classified Corrosive to skin (Category 1C).