Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion:
The study (Biosearch Inc., 1980) was carried out with rabbit based on equivalent or similar to Section 173.240(a) (1) and Appendix A to that part, Title 49 CFR and Section 1500.41 Title 16 CFR. The study showed that Methylenebis (dibutyldithiocarbamate) is not irritating or corrosive.
Eye irritation:
The study (Biosearch Inc., 1980) was carried out with rabbit based on equivalent or similar to Section 1500.42-Federal Hazardous Substances Act Regulations-CFR 16 P. 125. The study showed that Methylenebis (dibutyldithiocarbamate) is not irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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
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

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

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 to 24 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..
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.

No additional data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

No additional data
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was not washed from the eyes.

SCORING SYSTEM: Draize Scale of Scoring Ocular Lesions.

No additional data
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritant / corrosive response data:
No information provided
Other effects:
No information provided

Individual Daily Scores

Rabbit number

Tissue

Item

Readings

1 day

2 day

3 day

5 day

7 day

1

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

6

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Methylenebis (dibutyldithiocarbamate) is not irritating to the rabbit eyes in this test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

In a study (Biosearch Inc., 1980) was conducted to test guidelines equivalent or similar to Section 173.240(a) (1) and Appendix A to that part, Title 49 CFR and Section 1500.41 Title 16 CFR (not conducted to GLP), rabbits were exposed to Methylenebis (dibutyldithiocarbamate) (unchanged). The study showed that Methylenebis (dibutyldithiocarbamate) is not irritating or corrosive to the skin.

 

Eye irritation:

The study (Biosearch Inc., 1980) was conducted to test guidelines equivalent or similar to Section 1500.42-Federal Hazardous Substances Act Regulations-CFR 16 P. 125 (not conducted to GLP), rabbits were exposed toMethylenebis (dibutyldithiocarbamate) (unchanged). The study showed that Methylenebis (dibutyldithiocarbamate) is not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
This study was carried out with rabbit based on equivalent or similar to Section 173.240(a) (1) and Appendix A to that part, Title 49 CFR and Section 1500.41 Title 16 CFR. The study was not performed under GLP conditions due to the age of the study (1980) and the location of the study laboratory (USA). This was considered not to effect validity as the study was conducted at a reputable contract research organisation.
The only deviation from the test guidelines was that the wrapping use was occlusive, rather than semi-occulisive. This deviation was considered not to effect the validity of the study.
The study was not performed under GLP conditions due to the age of the study (1980) and the location of the study laboratory (USA). This was considered not to effect validity as the study was conducted at a reputable contract research organisation.

Justification for selection of eye irritation endpoint:
The study (Biosearch Inc., 1980) was conducted to test guidelines equivalent or similar to Section 1500.42-Federal Hazardous Substances Act Regulations-CFR 16 P. 125. The study was not performed under GLP conditions due to the age of the study (1980) and the location of the study laboratory (USA). This was considered not to effect validity as the study was conducted at a reputable contract research organisation.

Justification for classification or non-classification

Skin irritation

In a skin irritation study on Methylene bis (dibutyldithiocarbamate), all 5 animals showed Erythema score (mean) = 0, Edema score (mean) = 0, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Methylene bis (dibutyldithiocarbamate) is not classified for skin irritation/corrosion.

 

Eye irritation

In an eye irritation study conducted using Methylene bis (dibutyldithiocarbamate), the results showed a Cornea score (mean) = 0, Iris score (mean) = 0, conjunctival redness (mean) = 0 & chemosis (mean) = 0, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Methylene bis (dibutyldithiocarbamate) is not classified for eye irritation.