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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Department of Transportation, Hazardous Materials Regulations, Federal register Vol. 37, No. 57, March 23, 1972
Deviations:
yes
Remarks:
No reading after 48 h and 14 days. Occlusive instead of semi-occlusive (worst case).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
m-tolylidene diisocyanate
EC Number:
247-722-4
EC Name:
m-tolylidene diisocyanate
Cas Number:
26471-62-5
Molecular formula:
C9H6N2O2
IUPAC Name:
2,4-diisocyanato-1-methylbenzene, 2,6-diisocyanato-1-methylbenzene
Details on test material:
Incomplete test substance characterization.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hours
Observation period:
4 h, 24 h, 48 h, 72 h, and 7 days
Number of animals:
6
Details on study design:
TEST SITE
- Preparation: Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit. Two test sites located lateral to the midline of the back approximately 10 cm apart were selected. One site was abraded by making four epidermal incisions, while the other test site remained intact.
- Type of wrap if used: The test sites were covered with two-inch square gauze patches which were secured with masking tape. The trunk of each animal was then wrapped with plastic sheeting.

OBSERVATION TIME POINTS
4, 24, and 72 hours

SCORING SYSTEM:
- Method of calculation:
Scoring for erythema and edema was performed on a graded scale of 0 to 4.
The average irritation was calculated by the mean scores for erythema and edema after 4, 24, and 72 hours.
These values were totaled for abraded and intact skin and divided by six to obtain the mean primary irritation score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4/24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4/24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4/24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 4/24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 4/24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 4/24/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4/24/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4/24/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 4/24/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 4/24/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 4/24/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 4/24/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
After seven days all animals exhibited a grade 2 erythema and a grade 1 to 2 edema with fissuring, fatigued skin and desquamation. No destruction or irreversible changes of the tissue structure were reported.

Any other information on results incl. tables

4-hour exp.

animal #

abraded skin

intact skin

(4 hr)

(24 hr)

(72 hr)

(4 hr)

(24 hr)

(72 hr)

ER

ED

ER

ED

ER

ED

ER

ED

ER

ED

ER

ED

1

2

4

2

2

2

1

2

4

2

2

2

1

2

2

4

2

4

2

1

2

4

2

4

2

1

3

2

4

2

4

2

1

2

4

2

4

2

1

4

2

4

2

3

2

1

2

4

2

3

2

1

5

2

4

2

3

2

2

2

4

2

3

2

1

6

2

4

2

2

2

2

2

4

2

2

2

1

Mean

2

4

2

3

2

1.3

2

4

2

3

2

1

(ER = erythema; ED = edema)

Erythema score 1: barely perceptible (edges of area not defined)

Erythema score 2: pale red in color and area definable

Erythema score 3: definite red in color and area well defined

Erythema score 4: beet or crimson red in color

Edema score 1: barely perceptible (edges of area not defined)

Edema score 2: area definable but not raised more than 1 mm

Edema score 3: area well defined and raised approximately 1 mm

Edema score 4: area raised more than 1 mm

Injury In Depth 8: escharosis, necrosis

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria