Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24 to 27 June 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with relevant guidelines. Not conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: Section 173.240(a) (1) and Appendix A to that part, Title 49 CFR and Section 1500.41 Title 16 CFR.
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Wrapping used was occlusive, not semi-occlusive. This deviation was considered not to effect the validity of the study result.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: not specified
Purity: not specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.

No additional data

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

No additional data
Duration of treatment / exposure:
Primary skin irritation study: 24 hours
D.O.T. skin corrosivity study: 4 hours
Observation period:
Primary skin irritation study: 72 hours
D.O.T. skin corrosivity study: 48 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap if used: Gauze patches were placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 24 hours for primary skin irritation study and 4 hours for D.O.T. study.

SCORING SYSTEM: The Draize method of scoring was employed.

No additional data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Primary skin irritation study: Intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Primary skin irritation study: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24 and 48 hours
Score:
0
Max. score:
0
Remarks on result:
other: D.O.T. skin corrosivity study: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24 and 48 hours
Score:
0
Max. score:
0
Remarks on result:
other: D.O.T. skin corrosivity study: intact skin
Irritant / corrosive response data:
No information provided
Other effects:
No information provided

Any other information on results incl. tables

Primary skin irritation study

 

Reading (Hours)

Rabbit number

1

2

3

4

5

6

Erythema and Eschar Formation

Intact skin

24

0

0

0

0

0

0

Intact skin

72

0

0

0

0

0

0

Abraded skin

24

0

0

0

0

0

0

Abraded skin

72

0

0

0

0

0

0

Edema Formation

Intact skin

24

0

0

0

0

0

0

Intact skin

72

0

0

0

0

0

0

Abraded skin

24

0

0

0

0

0

0

Abraded skin

72

0

0

0

0

0

0

D.O.T. skin corrosivity study

Rabbit number

Reading times

4 hours

24 hours

48 hours

1

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

2

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

3

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

4

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

5

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

6

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

No erythema

No edema

No corrosion

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Methylenebis (dibutyldithiocarbamate) is not irritating to intact and abraded rabbit skin in the primary skin irritation study and not corrosive to intact rabbit skin in the D.O.T. skin corrosivity study.