4,4'-methylene bis(dibutyldithiocarbamate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

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

Test material information

Constituent 1

Reference substance name:

4,4'-methylene bis(dibutyldithiocarbamate)

EC Number:

233-593-1

EC Name:

4,4'-methylene bis(dibutyldithiocarbamate)

Cas Number:

10254-57-6

Molecular formula:

C19H38N2S4

IUPAC Name:

N,N-dibutyl({[(dibutylcarbamothioyl)sulfanyl]methyl}sulfanyl)carbothioamide

Details on test material:

Batch No.: not specified
Purity: not specified

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.