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EC number: 205-286-2 | CAS number: 137-26-8
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Apr - 2 May 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- individual body weight at study termination was not reported
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- adopted 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Thiram
- EC Number:
- 205-286-2
- EC Name:
- Thiram
- Cas Number:
- 137-26-8
- Molecular formula:
- C6H12N2S4
- IUPAC Name:
- thiram
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Instituut, Someren, The Netherlands
- Age at study initiation: ca. 18-19 weeks
- Weight at study initiation: not reported
- Housing: individually in "Lurane" plastic cages
- Diet: pelleted standard laboratory diet (Hope Farms, Woerden), 100 g per day and animal
- Water : tap water, ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -21
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29 Apr 1985 To: 2 May 1985
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: Untreated flanks were used as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of test substance was moistened with 0.5 mL of distilled water immediately before dosing.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): the right flank was covered without test substance as a negative control.
POSITIVE CONTROL: No positive control substance was applied. No positive control data was provided. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 10 cm² of the central back of the animals was clipped one day before treatment. The test substance was evenly spread on a patch of 6 cm² and applied to the left flank of each animal.
- Type of wrap if used: metalline wound dressing, attached to tape (Micropore) and wrapped in flexible bandage (Coban).
REMOVAL OF TEST SUBSTANCE
- Washing: tissue moistened with tap water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Exposed skin sites were examined for signs of erythema and oedema and the responses were scored at 30-60 minutes, and approximately 24, 48 and 72 hours after patch removal. For reference the control site on the contra lateral flank was used. Examination time points: 0.5-1, 24, 48, 72 h after removal of the test patch.
SCORING SYSTEM:
- Method of calculation: According to Draize scoring system
Erythema 0-4:
0: No erythema, 1: very slight erythema (barely perceptible), 2: well-defined erythema, 3 moderate to severe erythema, 4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema 0-4:
0: No oedema, 1: very slight oedema (barely perceptible), 2: well-defined oedema (edges of area well-defined by definite raising), 3: moderate to severe oedema (raised approximately 1mm), 4: severe oedema (raised more than 1 mm extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1 h and 24 h after patch removal, erythema of grade 1 were observed which were fully reversible at the 48 h reading time point.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 2 - 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 1/6 animals showed erythema (scored with grade 1) at the 1 h and 24 h observation time point. No skin reaction was seen in this animals thereafter or in any other animal for any time point.
Summarized results can be found in Attachment 1 in the attached background material.
Applicant's summary and conclusion
- Interpretation of results:
- other: According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.
- Conclusions:
- The study is in accordance with EPA OPP 81-5 (Acute Dermal Irritation) and GLP.
Under the conditions chosen, a single semi-occlusive application of the test substance to intact rabbit skin for 4 h elicited no dermal irritation. Overall, except of very slight erythema (score 1) observed in one animal persistent for 24 hours, no signs of dermal irritation including erythema and oedema were noted in the other treated animals. No other adverse effects to the treatment have been noted. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.
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