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EC number: 223-384-3 | CAS number: 3865-34-7
- 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
Read-across to DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS No. 57583-35-4)
Significant differences between the test group and the vehicle-treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583 -35 -4), see attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 mL at 0.1 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 mL at 0.1 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Composition/purity of the test substance not reported.
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- other: Maurer et al, 1975
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- The study was conducted prior to the LLNA becoming the preferred method.
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy
- Weight at study initiation: 400 to 450 g
- Housing: individually in Macrolon cages, type 3
- Diet (e.g. ad libitum): NAFAG, Gossau SG pellets; ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity 55 ± 5%
- Photoperiod (hrs dark / hrs light): 14 hours light / 10 hour dark - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 mL (0.1 %)
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 mL
- No. of animals per dose:
- 20
- Details on study design:
- During the first week volumes of 0.1 mL of the test material (0.1%) in saline without adjuvant were injected intradermally on Monday at two sites (flank and back), and on Wednesday and Friday at each one site on the back. Twenty-one hours after administration, the animals were chemically depilated with Butoquick and three hours later the skin reaction was assessed under artificial lighting. The two largest diameters of the erythematous reaction in vertical alignment were measured (mm) and the skin-fold thickness was determined with a skin-fold gauge (mm). The individual "reaction volume" (µL) was calculated from these values for each reaction from each animal.
During the second and third week of induction the substance was mixed with adjuvant (Bacto Adjuvant, complete Freund's Adjuvant) in a 1:1 ratio. A total of 6 sensitising doses of 0.1 mL were injected intracutaneously into the skin of the neck on Monday, Wednesday and Friday. The reactions were not evaluated on these occasions. The test for skin sensitisation was performed two weeks after the last sensitising treatment with the adjuvant mixture. For the test 0.1 mL of the same substance formulation, as employed during the first testing week, was injected intradermally on the previously untreated flank. Twenty-four hours later the reaction site was evaluated in the same manner as during the first testing week.
A group of 20 guinea pigs treated in the same manner with the control vehicle alone served as negative and another group treated with dinitrochlorobenzene as positive control.
For each animal the mean value plus one standard deviation was calculated for the reaction volumes of the 4 intracutaneous injections from the first testing week. Ten days after the intracutaneous challenge injection sub irritant doses at the test compound were applied epicutaneously under occlusive dressing which were left in place for 24 hours. - Challenge controls:
- Twenty guinea pigs were treated in the same way with the control vehicle alone served as the negative controls.
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
- Positive control results:
- - Significant skin sensitisation
- Rate of positive reactors: 20/20 animals - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Interpretation of results:
- other: EU Category 1 (H317: May cause an allergic skin reaction).
- Conclusions:
- Significant differences between the test group and the vehicle-treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs.
- Executive summary:
The optimisation test was used, an intracutaneous sensitisation procedure, to determine the sensitisation potential of the test material. The test was performed on groups of 10 male and 10 female guinea pigs. Dinitrochlorobenazene was used as the positive control. Skin sensitisation was defined to occur for the challenge reaction whenever the reaction volume exceeded the mean value plus one SD of the 4 pre-sensitisation reponses.
Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were found with the test material. The compound therefore has a skin sensitising (contact allergenic) potential in albino guinea pigs.
Referenceopen allclose all
A positive reaction was observed.
Erythema scores (Draize scores), 24 hours after removal of dressing, by sex: Males: 4/10 had a score of 1 Females: 7/10 had a score of 1
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Read-across to DMTC (Dimethyltin dichloride CAS No. 753 -73 -1) was not possible as no skin sensitisation study was performed on DMTC due to its corrosivity. In accordance with column 2 specific rules for adaptation from column 1) of Annex VIII of Regulation (EC) No. 1907/2006, the skin sensisation study required in section 8.3 can be omitted if the available data indicates that the substance should be classified for skin sensitisation or corrosivity. The available data on DMTC leads to its classification as corrosive. As a result read-across to DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS No. 57583-35-4) was used for the registered substance.
Read-across to DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS No. 57583-35-4)
In a Maurer Optimisation Test, the test material was weakly sensitising to the skin of male and female albino guinea pigs. At 24 hours after removal of the dressing, the Draize scores for 4/10 males and 7/10 females were 1. Based on the results of a Buehler Test, a blend of the test material in 50 % (w/v) acetone did not induce sensitisation in guinea pigs. The optimisation testing protocol provides a more-sensitive measure of sensitisation than the Buehler method.
Dermal sensitisation in guinea pigs from the key study: sensitiser
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance requires classification with respect to skin sensitisation Category 1 (H317: May cause an allergic skin reaction).
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.
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