Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-696-2 | CAS number: 13927-77-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- 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 test substance shows no indication of skin irritation.
The test substance is classified as irritating to the eyes.
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:
- 29 Oct 1985 to 3 Nov 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Toxic Substances Control Act Draft Guidelines; Office of Toxic Substances; Office of Pesticides and Toxic Substances; United States Environmental Protection Agency; August 1982; Acute Exposure, Primary Dermal Irritation.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of the test item (as cited in study report): Nickel dibutyldithiocarbamate
- Batch No.: 0131100 NF
- Appearance: Green, powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 1.9-3.1 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: SDS Standard Rabbit Diet, ad libitum
- Water: tap water, ad libitum
ENVIRONMENT
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A 0.5 g amount of the test substance was applied under a 2.5 cm square gauze pad moistened with 0.5 mL saline to two intact and two abraded skin sites on each animal.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 5 day
- Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
- Immediately prior to application of the test substance, two areas of skin approximately 2.5 cm square on the right side of the spine were abraded using the tip of a scalpel blade to make minor incisions through the stratum corneum. These were not deep enough to disturb the dermis or cause bleeding. Two similar sites on the left side remained intact.
- The treatment sites were occluded with "Elastoplast" elastic adhesive dressing for approximately 24 hours. "Elizabethan collars" were placed on each animal in order to prevent the animal from disturbing the test sites. The animals were not restrained during thee exposure period and were returned to their cages.
REMOVAL OF TEST SUBSTANCE
At the end of the exposure period the semi-occlusive dressing and gauze pads were removed and the treatment sites wiped to remove any residual test substance.
OBERVATIONS AND SCORING
Examination of the treated skin sites was made approximately 30 minutes and 24, 48, 72 and 96 hours after removal of the patches. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the 5-day observation period.
- Interpretation of results:
- GHS criteria not met
Reference
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of the test item (as cited in study report): Nickel dibutyldithiocarbamate
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- ENVIRONMENT
- Housing: The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye per animal served a control
- Amount / concentration applied:
- 100 mg of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- - The eyes are examined before testing and only those animals without observable eye defects were used.
- The eyes are not washed following instillation and the animals are released immediately.
- The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Ocular reactions are read using a binocular magnifying glass. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days except for animal #2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days except for animal #2
- Irritation parameter:
- iris score
- Basis:
- animal: #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days except for animal #4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3, #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Irritating effects on the rabbit eye were reported in the key study (corneal opacity score ≥ 1 and iritis score ≥ 1). The study was limited by a reduced observation period (7 days in stead of 21 days), even though some effects were not fully reversed at day 7. Given that the supporting study shows no indication of eye irritation in rabbits, it is assumed that effects observed in the key study would have been fully reversed after 21 days after exposure. Therefore, the test substance is classified as irritating, but not corrosive.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
In a pre-GLP study similar to OECD TG 404, skin irritation was assessed with six New-Zealand rabbits. The intact skin (clipped) of the animals were exposed to 0.5 g of the test substance on an area of 2.5 cm² under a gauze pad (semi-occlusive) moistened with 0.5 ml saline for 24 hours. Examination was made approximately 30 minutes and 24, 48, 72, 96 hours after exposure.
Based on the average erythema and oedema scores, the substance is considered to be not irritating to skin.
In a pre-GLP study similar to OECD TG 404, skin irritation was assessed with twelve New-Zealand rabbits (six on intact skin and six on abraded skin). Animals were exposed to 0.5 g of the test substance on an area of ca. 2.5 cm² for 24 hours. Examinations were made 24 and 72 hours after the start of the exposure. Only in one animal, very slight erythema was observed. Based on the average erythema and oedema scores, the substance is considered to be not irritating to skin.
Eye irritation
In a pre-GLP acute toxicity study similar to OECD 405, eye irritation was assessed with six New Zealand rabbits. Animals were exposed to 100 mg of the test substance. Eyelids were held together for one second before releasing. The eyes were not rinsed afterwards. The untreated eye served as a control. Eyes were examined 1 hour and 1, 2, 3, 4 and 7 days after instillation and scored according to the Draize scale. 24 hours after the test substance had been brought into the eyes, the following effects were observed: slight to moderate corneal opacity, slight iritis, moderate redness of the conjunctivae and swelling with eye lids half closed. Ocular lesions recovered partly over the following days. At Day 7, the following effects were observed: Very slight corneal opacity in two rabbits, slight iritis in one rabbit, and slight conjunctivitis in five rabbits. Under the conditions of the test, the test substance was considered irritating to the eyes.
In a pre-GLP acute toxicity study similar to OECD 405, eye irritation was assessed with six New Zealand rabbits. Animals were exposed to 65 mg of the test substance. Eyelids were held together for one second before releasing. The eyes were not rinsed afterwards. The untreated eye served as a control. Eyes were examined 1 hour and 1, 2, 3, 4 and 7 days after instillation and scored according to the Draize scale. Two animals gave a positive response. Redness of the conjunctivae was observed in two animals one day after instillation. Transient mild conjunctival reactions were seen in three animals. All eyes were normal one to three days after instillation. Under the conditions of the test, the test substance was not considered irritating to eyes.
Justification for classification or non-classification
Based on the results of the available studies, classification for skin irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
Based on a worst-case approach, the test substance has to be classified as Eye Irrit. 2: H319: Causes serious eye irritation in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008. Irritating effects on the rabbit eye were reported in the key study (corneal opacity score ≥ 1 and iritis score ≥ 1). The study was limited by a reduced observation period (7 days in stead of 21 days), even though some effects were not fully reversed at day 7. Given that the supporting study shows no indication of eye irritation in rabbits, it is assumed that effects observed in the key study would have been fully reversed after 21 days after exposure. Therefore, the test substance is classified as irritating, but not corrosive.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.