Registration Dossier
Registration Dossier
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EC number: 233-593-1 | CAS number: 10254-57-6
Endpoint summary
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
- 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
- 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
- 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
- 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 - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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.
Reference
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 |
|
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). This was considered not to effect validity, as the study was
conducted at a reputable contract research organization in the USA for
submission to the US Environmental Protection Agency.
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). This was considered not to effect validity, as the study was conducted at a reputable contract research organization in the USA for submission to the US Environmental Protection Agency.
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.
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