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EC number: 203-103-0 | CAS number: 103-34-4
- 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
4,4'-dithiodimorpholine is not skin or eye irritant in rabbits.
However 4,4'-dithiodimorpholine is irritating for the respiratory tract.
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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or test system and environmental conditions:
- no
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of DTDM, as a finely groud powder moistened with water
- Duration of treatment / exposure:
- 24 hr
- Observation period:
- 24, 48, 72 and 168 hours after topical application.
- Number of animals:
- 6 animals / dose
- Details on study design:
- TEST SITE
- Area of exposure: to the shaved dorsal of rabbits
- % coverage: DTDM was applied to the skin under 1'' square gauze patches
- Type of wrap if used: an occlusive wrap latex rubber secured by bandaging and elastic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hr
SCORING SYSTEM:
Dermal irritation was scored by Draize Method.
The primary irritation Index was calculated by averaging the mean scores at 24 and 72 hours. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n/a
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.05
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Abraded skin
- Irritant / corrosive response data:
- Small effects were observed at 24 hours (score of 1 of each animal).
Similar effects is observed on intact skin and on abraded skin. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- DTDM was not irritating to the intact or abraded skin.
- Executive summary:
In a pre-guideline study, 0.5 grams of 4,4'-dithiodimorpholine, as a finely ground powder moistened with water, was applied to the shaved or abraded dorsal areas of six albino rabbits. The test material was applied to the skin under 1” square gauze patches and held in contact with the skin by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape. The occlusive wrap and gauze patches were removed after 24 hours. Dermal irritation was scored by the Draize Method, and results were recorded 24, 48, 72 and 168 hours after topical application. All six rabbits showed a very slight reaction (erythema) with a score of 1 at 24 hours on both the intact or abraded skin, effects were fully reversible at 48 hours (score of 0 at 48 hours). Oedema (score 1) was recorded in one rabbit at 24 hours on the abraded skin. According to these results, 4,4'-dithiodimorpholine is considered as not skin irritant.
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
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method of Draize (1944)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or tissues and environmental conditions:
- no
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of DTDM, as a finely ground powder - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hr
SCORING SYSTEM: The Draize Method - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 8.4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: "conjunctivae score" not detailed in the report
- Irritant / corrosive response data:
- Immediate = slight discomfort ; At 1 hour = moderate erythema, slight edema, copious discharge; At 24 hours = moderate to severe erythema, very slight edema, copious discharge containing whitish exudate ; At 48 hours and at 72 hours = gradual improvement; At 168 hours = all animals scored "0".
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4,4'-dithiodimorpholine was not irritating for the eyes.
- Executive summary:
In a pre-guideline study, 100.0 mg of 4,4'-dithiodimorpholine, as a finely ground powder, was applied to one eye of six albino rabbits. The other eye was not treated and served as a control. The cornea, iris and conjuntivea were examined immediately after treatment, and then at intervals of 1 hour, and at 24, 48, 72 and 168 hours. The Draize Method was used for scoring eye irritation. A slight discomfort was observed immediately after the instillation. At 1 hour, moderate erythema, slight edema and copious discharge were observed. At 24 hours, moderate to severe erythema, very slight edema, and copious discharge containing whitish exudate were still observed. At 48 and 72hours, the effects gradually improved. At 168 hours, all animals scored “0”. The average Draize score for 24, 48 and 72 hours was calculated for each animal and then averaged over the six animals. The average Draize score was 8.4 on a scale from 0-110. 4,4'-dithiodimorpholine is considered as not eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
In a pre-guideline study (Birch, 1974b), 0.5 grams of 4,4'-dithiodimorpholine, as a finely ground powder moistened with water, was applied to the shaved or abraded dorsal areas of six albino rabbits. The test material was applied to the skin under 1” square gauze patches and held in contact with the skin by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape. The occlusive wrap and gauze patches were removed after 24 hours. Dermal irritation was scored by the Draize Method, and results were recorded 24, 48, 72 and 168 hours after topical application. All six rabbits showed a very slight reaction (erythema) with a score of 1 at 24 hours on both the intact or abraded skin, effects were fully reversible at 48 hours (score of 0 at 48 hours). Oedema (score 1) was recorded in one rabbit at 24 hours on the abraded skin. According to these results, 4,4'-dithiodimorpholine is considered as not skin irritant.
Eye irritation
In a pre-guideline study (Birch, 1974c), 100.0 mg of 4,4'-dithiodimorpholine, as a finely ground powder, was applied to one eye of six albino rabbits. The other eye was not treated and served as a control. The cornea, iris and conjuntivea were examined immediately after treatment, and then at intervals of 1 hour, and at 24, 48, 72 and 168 hours. The Draize Method was used for scoring eye irritation. A slight discomfort was observed immediately after the instillation. At 1 hour, moderate erythema, slight edema and copious discharge were observed. At 24 hours, moderate to severe erythema, very slight edema, and copious discharge containing whitish exudate were still observed. At 48 and 72hours, the effects gradually improved. At 168 hours, all animals scored “0”. The average Draize score for 24, 48 and 72 hours was calculated for each animal and then averaged over the six animals. 4,4'-dithiodimorpholine is considered as not eye irritant.
Respiratory tract irritation
Respiratory tract irritation could be studied in the 90 -day repeated toxicity study performed with DTDM by inhalation (Sieber 2014). In this study, histopathological changes in the larynx of both sexes were noted in a concentration-related manner. These findings included focal squamous metaplasia, focal hyperplasia of squamous epithelium, submucosal inflammation and focal erosion/ulceration. The latter finding was noted in group 4 only. After the end of the recovery period, complete recovery was observed in groups 2 and 3 and partial recovery in group 4.
There were no further findings that were considered to be related to treatment. Based on the findings in the larynx, the NOAEC (No-Observed-Adverse-Effect-Concentration) for local effects was considered to be 0.507 mg 4,4’-Dithiodimorpholine/m3 air.
Justification for classification or non-classification
Based on the available data, no classification for skin or eye irritation is required for the registrated substance according to the Regulation (EC) No 1272/2008. However, the registered substance is considered as irritating for the respiratory tract : STOT SE 3, H335 “May cause respiratory irritation”.
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