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EC number: 237-695-7 | CAS number: 13927-71-4
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The potential of the test substance copper dibutyl dithiocarbamate (CDBC) to induce skin and eye irritation was evaluated in rabbits according to the OECD guideline (OECD 404 and 405). According to these studies, CDBC is slightly irritant for skin and eye, and no classification is required for these endpoints.
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
- Study period:
- 3-14 April 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Minors deviations were observed but not considered to have compromised the validity or integrity of the study.
- Principles of method if other than guideline:
- Minor deviations observed: relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol, the animal's breeder was CEGAV, the animals were given 110 pelleted diet (instead of 112).
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-sex: male
- Source: CEGAV, 61350 Saint Mars d'Egrenne, France
- Age at study initiation: no data
- Weight at study initiation: 3.2 ± 0.1 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): free access to 110 pelleted diet (UAR, Villemoisson, Epinay sur orge, France)
- Water (e.g. ad libitum): water filtered, ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 3 minutes and 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION:
- Area of exposure: application for 4 hours on the right flank and for 3 minutes on the left flank
- Total quantity applied: 500 mg
- Administration frequency: once
- Removal of test substance: residual was wiped off by means of moistened cotton pad.
EXAMINATIONS:
- Scoring system: Draize's score
- Examination time points: 1h, 24 h, 48 h and 72 hours after the patch removal. When persistent irritation reactions were noted at 72 hours, the observation period was extended up daily to their complete reversibility (day 10). - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: not evaluated in the two other animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- AFTER 3-MINUTE EXPOSURE: No cutaneous reaction was observed but a brown coloration of the skin which could have masked a possible very slight erythema between days 1 and 3.
AFTER 4-HOUR EXPOSURE:
- A brown coloration of the skin was noted in all animals. It could have masked a possible very slight or a well-defined erythema in 2 animals, up to day 3 (72h) or 5 but no cutaneous reaction was noted afterwards. In these two animals, no oedema was observed. However, it should be noted that in worst case, the mean irritation scores would have remained lower than 2, for these 2 animals.
- In the third rabbit, the brown coloration was resolved by the 24-hour scoring interval and a well-defined erythema was recorded: grade 2-erythema from day 2 up to day 5 and a grade 1 up to day 9. Moreover, a slight oedema (grade 2) was noted on day 3.
MEAN SCORES OVER 24, 48 AND 72h:
- For erythema: not calculable for 2 animals because of the skin coloration and 2.0 in the third animal.
- For oedema: 0.0, 0.0 and 0.7. - Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin irritating
- Conclusions:
- Under these experimental conditions, the test substance CDBC is slightly irritant when applied topically to rabbits.
- Executive summary:
The potential of the test substance CDBC to induce skin irritation was evaluated in rabbits according to OECD (404) and EC guidelines, and in compliance with the principles of GLP.
In the first instance, the test substance was applied for periods of 3 minutes and 4 hours to a single male rabbit. Since the test substance was not severely irritant on the first animal, it was than applied for 4 hours to two other animals. A single dose of 500 mg of CDBC in its original form was applied to the closely-clipped skin of one flank. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions. The mean values of the scores for erythema and oedema were calculated for each animals.
After a 3-minute exposure (one animal): no cutaneous reactions were observed. A brown coloration of the skin was noted; it could have masked a possible very slight erythema between days 1 to 3.
After a 4 -hour exposure (three animals): A brown coloration of the skin was noted in all animals; it could have masked a possible very slight or well-defined erythema up to day 3 (one animal) or 5 (one animal). No cutaneous reactions were observed afterwards in these two animals. In the third animal, a well-defined erythema was noted from day 2 to day 5, then a very slight erythema was recorded up to day 9. A slight oedema was noted on day 3.
Mean scores over 24, 48 and 72 hours were not calculable for eryhtema because of the skin coloration for two animals. In the third animal, mean scores were 2.0 for erythema and 0.7 for oedema.
Under these experimental conditions, the test substance CDBC is slightly irritant when applied topically to rabbits.
Reference
Table 1: individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for the first animal (application for 3 minutes)
Rabbit number |
Dermal irritation |
scores |
Mean irritation score (1) |
|||
1h (D1) |
24h (D2) |
48h (D3) |
72h (D4) |
|||
994 |
Erythema |
C1 |
C1 |
C1 |
0 |
(2) |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
C |
|
(1) mean of scores on days 2, 3 and 4, (2): not calculated
* : none, D = day, h = hour
C = Brown coloration of the skin
C1 = brown coloration of the skin which could have masked a possible very slight erythema
Table 2: individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal (application for 4 hours)
Rabbit number |
Dermal irritation |
scores |
Mean irritation score (1) |
|||
1h (D1) |
24h (D2) |
48h (D3) |
72h (D4) |
|||
994 |
Erythema |
C2 |
C2 |
C1 |
C1 |
(2) |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
576 |
Erythema |
C2 |
C2 |
C1 |
0 |
(2) |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
C |
|
|
577 |
Erythema |
C2 |
2 |
2 |
2 |
2.0 |
Oedema |
0 |
0 |
2 |
0 |
0.7 |
|
Other |
* |
C |
C |
C |
|
Rabbit number |
Dermal irritation |
Scores |
|||||
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
||
994 |
Erythema |
C1 |
0 |
- |
- |
- |
- |
Oedema |
0 |
0 |
- |
- |
- |
- |
|
Other |
* |
C |
- |
- |
- |
- |
|
576 |
Erythema |
- |
- |
- |
- |
- |
- |
Oedema |
- |
- |
- |
- |
- |
- |
|
Other |
- |
- |
- |
- |
- |
- |
|
577 |
Erythema |
2 |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
C |
C |
C |
C |
C |
C |
(1) mean of scores on days 2, 3 and 4, (2): not calculated
* : none, D = day, h = hour
C = Brown coloration of the skin
C1 = brown coloration of the skin which could have masked a possible very slight erythema
C2= brown coloration of the skin which could have masked a possible well-defined erythema
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:
- 10-15 April 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Minors deviations were observed but not considered to have compromised the validity or integrity of the study.
- Principles of method if other than guideline:
- Minor deviations observed: relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol, the animal's breeder was CEGAV, the animals were given 110 pelleted diet (instead of 112).
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation: no data
- Weight at study initiation: 3.4 ± 0.2 kg
- Housing: individually in polystyrene cages.
- Diet (e.g. ad libitum): 110 pelleted diet (UAR, Villemoisson, Epinay sur orge, France), free access
- Water (e.g. ad libitum): water filtered, ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control = untreated right eye
- Amount / concentration applied:
- A sinlge dose of 100 mg of the test substance first ground to a fine powder was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids held together for about one second to avoid any loss of test substance.
- Duration of treatment / exposure:
- one administration only
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
ADMINISTRATION:
- Administration frequency: once
EXAMINATIONS:
- Ophthalmoscopic examination: Yes
- Scoring system: Draize's score
- Observation period: 1h, 24h, 48h and 72h after administration of the test substance
- Tool used to assess corneal opacification: examination under UV lamp after instillation of 1 or 2 drops of fluorescein (on day 2 and whenever if necessary). - Irritation parameter:
- chemosis score
- Remarks:
- (chemosis)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean individual scores : 1.0, 0.7 and 0.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean individual scores : 1.0, 0.7 and 0.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Mean individual scores : 0.3, 0.3 and 0.3
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- (intensity)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Mean individual scores : 0.0, 0.3 and 0.3
- Irritation parameter:
- cornea opacity score
- Remarks:
- (area)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Mean individual scores : 0.0, 0.3 and 0.3
- Irritant / corrosive response data:
- CONJUNCTIVAE:
- very slight or slight chemosis and redness (grade 1 or 2) were observed from day 1, in all animals and were completely resolved by 72-hour scoring interval
- a clear discharge (grade 1 or 2) was noted too from day 1 in all animals and were completely resolved by 48h-hour scoring interval.
IRIS: A slight iritis (grade 1) was noted in 1 animal on days 1 and 2.
CORNEAL OPACITY: A very slight corneal opacity (grade 1) was observed in 2 animals on day 2 only.
MEANS SCORES CALCULATED FOR EACH ANIMAL:
- For chemosis: 1.0, 0.7 and 0.7
- For redness of conjunctiva: 1.0, 0.7 and 0.7
- For iris lesions: 0.3, 0.0 and 0.0
- For corneal opacity: 0.0, 0.3 and 0.3. - Interpretation of results:
- GHS criteria not met
- Remarks:
- not eye irritating
- Conclusions:
- Under these experimental conditions, the test substance CDBC is slightly irritant when administered by ocular route to rabbits.
- Executive summary:
The potential of the test substance CDBC to induce ocular irritation was evaluated in rabbits according to OECD (405) and EC guidelines, and in compliance with the principles of GLP.
As possible irritant effects were anticipated, the test substance was administered to a single male rabbit in the first instance. Since the test substance was not severely irritant on this first animal, it was evaluated in twho other animals.
A single dose of 100 mg of the test substance, first ground to a fine powder, was introduced into the left conjunctival sac. The right eye was not rinsed after administration of the test substance. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after administration. The mean values of the scores for chemosis, redness of the conjunctivae, iris lesions and corneal opacity were calculated for each animal.
Very slight or slight conjunctival reactions (slight chemosis, slight redness of the conjunctivae and clear discharge) were observed in all animals from day 1: some of these reactions persisted up to day 3. A slight iritis was noted in one animal on days 1 and 2. A very slight corneal opacity was recorded in two animals, on day 2 only. Mean scores calculared for each animal aver 24, 48 and 72 hours were 1.0, 0.7 and 0.7 for chemosis, 1.0, 0.7 and 0.7 for redness of the conjunctiva, 0.3, 0.0 and 0.0 for iris lesions and 0.0, 0.3 and 0.3 for corneal opacity.
Under these experimental conditions, the test substance CDBC is slightly irritant when administered by ocular route to rabbits.
Reference
Table 1: Individual ocular examination and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal
Rabbit number |
Region of eye |
Description of ocular reactions |
scores |
Mean irritation score (1) |
|||
1h (D1) |
24h (D2) |
48h (D3) |
72h (D4) |
||||
994 |
conjunctivae |
Chemosis |
2 |
2 |
1 |
0 |
1.0 |
Redness |
2 |
2 |
1 |
0 |
1.0 |
||
Discharge |
2 |
1 |
0 |
0 |
0.3 |
||
Iris |
1 |
1 |
0 |
0 |
0.3 |
||
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
Su |
* |
* |
* |
|
||
Fluorescein |
/ |
U |
/ |
/ |
|
||
576 |
conjunctivae |
Chemosis |
1 |
1 |
1 |
0 |
0.7 |
Redness |
1 |
1 |
1 |
0 |
0.7 |
||
Discharge |
2 |
1 |
0 |
0 |
0.3 |
||
Iris |
0 |
0 |
0 |
0 |
0.0 |
||
Corneal opacity |
Intensity |
0 |
1 |
0 |
0 |
0.3 |
|
Area |
0 |
1 |
0 |
0 |
0.3 |
||
Other |
Su |
Su |
* |
* |
|
||
Fluorescein |
/ |
U |
U |
/ |
|
||
577 |
conjunctivae |
Chemosis |
1 |
1 |
1 |
0 |
0.7 |
Redness |
2 |
1 |
1 |
0 |
0.7 |
||
Discharge |
2 |
1 |
0 |
0 |
0.3 |
||
Iris |
0 |
0 |
0 |
0 |
0.0 |
||
Corneal opacity |
Intensity |
0 |
1 |
0 |
0 |
0.3 |
|
Area |
0 |
1 |
0 |
0 |
0.3 |
||
Other |
Su |
Su |
* |
* |
|
||
Fluorescein |
/ |
U |
U |
/ |
|
(1) mean of scores on days 2, 3 and 4
* : none
U: fluorescein batch No.D616
/: fluorescein not used
Su: residual test substance
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation study (Manciaux 2001):
The potential of the test substance CDBC to induce skin irritation was evaluated in rabbits according to OECD (404) and EC guidelines, and in compliance with the principles of GLP.
In the first instance, the test substance was applied for periods of 3 minutes and 4 hours to a single male rabbit. Since the test substance was not severely irritant on the first animal, it was than applied for 4 hours to two other animals. A single dose of 500 mg of CDBC in its original form was applied to the closely-clipped skin of one flank. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions.
After a 3-minute exposure (one animal): no cutaneous reactions were observed. A brown coloration of the skin was noted; it could have masked a possible very slight erythema between days 1 to 3.
After a 4 -hour exposure (three animals): A brown coloration of the skin was noted in all animals; it could have masked a possible very slight or well-defined erythema up to day 3 (one animal) or 5 (one animal). No cutaneous reactions were observed afterwards in these two animals. In the third animal, a well-defined erythema was noted from day 2 to day 5, then a very slight erythema was recorded up to day 9. A slight oedema was noted on day 3.
Mean scores over 24, 48 and 72 hours were not calculable for eryhtema because of the skin coloration for two animals. In the third animal, mean scores were 2.0 for erythema and 0.7 for oedema.
Under these experimental conditions, the test substance CDBC is slightly irritant when applied topically to rabbits.
Eye irritation study (Manciaux 2001):
The potential of the test substance CDBC to induce ocular irritation was evaluated in rabbits according to OECD (405) and EC guidelines, and in compliance with the principles of GLP.
A single dose of 100 mg of the test substance, first ground to a fine powder, was introduced into the left conjunctival sac. The right eye was not rinsed after administration of the test substance. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after administration.
Very slight or slight conjunctival reactions (slight chemosis, slight redness of the conjunctivae and clear discharge) were observed in all animals from day 1: some of these reactions persisted up to day 3. A slight iritis was noted in one animal on days 1 and 2. A very slight corneal opacity was recorded in two animals, on day 2 only. Mean scores calculared for each animal aver 24, 48 and 72 hours were 1.0, 0.7 and 0.7 for chemosis, 1.0, 0.7 and 0.7 for redness of the conjunctiva, 0.3, 0.0 and 0.0 for iris lesions and 0.0, 0.3 and 0.3 for corneal opacity.
Under these experimental conditions, the test substance CDBC is slightly irritant when administered by ocular route to rabbits.
Justification for classification or non-classification
Proposed self-classification according to the Regulation (EC) No 1272/2008: not classified
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