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EC number: 283-381-8 | CAS number: 84604-96-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- GPMT (1983)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7th June to 5th July 1983
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Huntingdon Research centre was fully audited by quality assurance unit at that time, a signed Quality statement is within report but no mention of GLP status in report
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Performed in 1983 and reliable/ valid study according to OECD 406 & based on method described by Magnusson and Kligman " Allergic contact Dermatitis in the Guinea Pig"
Test material
- Reference substance name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- EC Number:
- 283-381-8
- EC Name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- Cas Number:
- 84604-96-6
- Molecular formula:
- C38H76N2S4Zn
- IUPAC Name:
- bis({[bis(3,5,5-trimethylhexyl)carbamothioyl]sulfanyl})zinc
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Off white powder, stored at ambient temperature
High Purity
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- albino
- Sex:
- male
- Details on test animals and environmental conditions:
- 30 male animals, acclimitised to lab environment. Weight at start of study ( mean) 483g; End of study mean weight was 617g
The guinea pigs were housed in suspended cages with wire mesh floors. They had free access to tap water and a vitamin C enriched guinea pig diet and hay was given weekly. Animal room temperature was aproximately 21 degrees C and relative humidity 30-70%
Air exchange was maintained at approximately 15 air changes per hour & lighting was controlled by a time switch
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: alembicol D
- Concentration / amount:
- Induction - intradermal - 2.5% w/w test substance in alembicol D
topical : 60% w/w in Alembicol D
Challenge: 20% & 10% w/w in Alembicol D - Day(s)/duration:
- Upon intradermal injections, one week elapsed before challenged.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: alembicol D
- Concentration / amount:
- 20 % and 10% w/w
- Day(s)/duration:
- Dressing was in place for 24
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals induction and all 20 in addition to 10 controls for challenge.
- Details on study design:
- RANGE FINDING TESTS: Preliminary investigation undertaken to determine substance concentration suitable for both induction and challenge.
Induction phase, selected concentration of test substnace that produced irritancy for both intradermal (2.5 %w/w ) and topical application (60% w/w )
Concentration for challenge phase was determined as 20% and 10% in vehicle
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injection
All twenty test animals
- 4x6 cm area of dorsal skin on the scapular region of the guinea pig. Three pairs of injections perpared and injected simultaneously as follows
1. Fruends complete adjuvant (1;1 with water)
2. 2.5w/w of test substance in Alembicol D
3. 2.5% w/w of test substance in 50;50 mix of Freunds and Alembicol D
Topical Application
One week after injections, same interscapular area was shaved free of hair and 60%w/w of test substance was placed on the skin and covered with dressing for 48 hours.
B. CHALLENGE EXPOSURE
- All 30 animals were challenged topically two weeks after induction period with concentration of test substance at 20% and 10% w/w in vehicle
OTHER: - Challenge controls:
- Freunds treated controls
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- n/a
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- Localised dermal reaction
- Remarks on result:
- other: Too small a number to be statistically significant
Any other information on results incl. tables
Dermal reactions in the test animals elicited by the challenge
applications were compared with the findings simulatneously obtained in
the control animals.
A test animal was considered to show positive evidence of delayed
contact hypersensitivity if the observed dermal reaction at challenge
was definitely more marked and or presistant than the maximum reaction
seen in animals of the control group
The numerical scores to dermal reactions elicited by the challenge is shown in table 1 attached. The dermal reactions ( defined erythema or slight erythema was observed in three out of twenty of the test animals at 72 hours which was more marked than controls. However, no evidence of delayed contact hypersensitivity was seen in the remaining seventeen guinea pigs at 72 hours. Based on these results the test substnace does not have to be classified and no classifcation criteria for skin sensitisation is required. (GHS 2015) nor CLP 1272/2008
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The threshold for delayed sensitivity in the study conducted to Magnusson and Kligman (1970) was not reached.
No evidence of delayed contact hypersensitivity was concluded for test substance .
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