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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Apr - 1 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2021
- Deviations:
- yes
- Remarks:
- methodological limitations (e.g. individual body weight at study termination was not reported, no anesthetic/analgesic pretreatment performed)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cpb/TNO, Zeist, The Netherlands
- Age at study initiation: adult, not further specified
- Weight at study initiation: 3591 - 3567 g (4 days before administration of the test susbtance)
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet (Hope Farms, Woerden), pelleted diameter 4 mm, 100 g per animal and day
- Water: tap water, ad libitum
- Acclimation period: at least 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 Apr 1985 To: 1 May 1985
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 g per animal
- Duration of treatment / exposure:
- eyes were not rinsed
- Observation period (in vivo):
- 15 days
Observations were performed immediatly after instillation of the test substance, and approximatly 1, 24, 48 and 72 h and 7 and 15 days after instillation of the test substance. - Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
SCORING SYSTEM:
Grades of ocular lesions: Cornea
Degree of Opacity 0 – 4 (0 = no finding, 1 = slight, disperse, diffuse opacity, 2 = extensive, diffuse opacity, iris blurred, 3 = nacreous areas, no details of iris visible, size of pupil hardly discernible, 4 = opaque cornea, iris not discernible through the opacity)
Iris 0 – 2 (0 = no finding, 1 = swelling, reddening, positive light reaction, 2 = severe reddening and swelling, no light reaction)
Conjunctivae
Redness 0 – 3 (0 = blood vessels normal, 1 = vessels abnormally filled, 2 = diffuse reddening, 3 = diffuse deep reddening)
Chemosis 0 – 4 (0 = no swelling, 1 = slight swelling, 2 =severe swelling, lids everted, 3 = lids cover one half of eye, 4 = lids cover more than half eye, necroses and ulcers on the conjunctivas)
Directly after instillation, 1 h, 24 h, 48 h, 72 h, 7 d, 15 d
Approximately 24 hours after instillation of the test substance (immediately after scoring the cornea/opacity), a solution of 2% fluorescein in water was applied to both eyes of each animal to examine quantitatively the potential for corneal injury. The brightly green staining area indicating epithelial damage was estimated as a percentage of the total corneal area. Any observed local effects were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- other: animal 1, 4, 5 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- other: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- other: 15 days
- Irritant / corrosive response data:
- The summarized results can be found in Table 1 and Attachment 1 in the attached background material
- Other effects:
- To calculate the mean, the scores from time points 24, 48 and 72 h after instillation of the test substance were used. The other observation points were ignored or used only to assess the reversibility of the effects.
Any other information on results incl. tables
There was no indication of a systemic effect of treatment.
Table 1. Results of eye irritation study. |
|||||
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
1 |
3 |
0 |
0 |
24 |
1 |
2 |
0 |
0 |
|
48 |
3 |
2 |
0 |
0 |
|
72 |
2 |
1 |
0 |
0 |
|
average |
2,0 |
1,7 |
0,0 |
0,0 |
|
2 |
1 |
1 |
2 |
0 |
0 |
24 |
1 |
3 |
0 |
0 |
|
48 |
3 |
3 |
1 |
0 |
|
72 |
2 |
2 |
1 |
0 |
|
average |
2,0 |
2,7 |
0,7 |
0,0 |
|
3 |
1 |
2 |
3 |
0 |
0 |
24 |
2 |
3 |
0 |
0 |
|
48 |
2 |
2 |
1 |
0 |
|
72 |
2 |
2 |
1 |
0 |
|
average |
2,0 |
2,3 |
0,7 |
0,0 |
|
4 |
1 |
2 |
3 |
0 |
0 |
24 |
3 |
2 |
0 |
0 |
|
48 |
3 |
2 |
0 |
0 |
|
72 |
2 |
2 |
0 |
0 |
|
average |
2,7 |
2,0 |
0,0 |
0,0 |
|
5 |
1 |
1 |
3 |
0 |
0 |
24 |
1 |
2 |
0 |
0 |
|
48 |
2 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1,3 |
1,3 |
0,0 |
0,0 |
|
6 |
1 |
2 |
2 |
0 |
0 |
24 |
3 |
2 |
0 |
0 |
|
48 |
3 |
3 |
0 |
0 |
|
72 |
3 |
2 |
0 |
0 |
|
average |
3,0 |
2,3 |
0,0 |
0,0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
1,50 |
2,67 |
0,00 |
0,00 |
24 |
1,83 |
2,33 |
0,00 |
0,00 |
|
48 |
2,67 |
2,17 |
0,33 |
0,00 |
|
72 |
2,00 |
1,67 |
0,33 |
0,00 |
|
24+48+ 72 |
2,17 |
2,06 |
0,22 |
0,00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The study is in accordance with EPA OPP 81-4 (Acute Eye Irritation) and GLP. Under the conditions chosen, instillation of the test substance into the eyes of 6 female rabbits elicited a positive response. According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, classification for eye Irritation Category 2 (H319) is warranted.
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.