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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
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- 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
key, skin irritation (rabbit, EPA OPP 81-5): not irritating
key, skin irritation (rabbit, 21 day, OECD 410): irritating
key, eye irritation (rabbit, EPA OPP 81-4): irritating
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:
- 29 Apr - 2 May 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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
- 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 - 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) - 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 16 Apr - 1 May 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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
- 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 - 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. - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Effects on skin irritation:
In a GLP-compliant study conducted according to EPA OPP 81-5 and similar to OECD 404, the test substance showed no skin irritating potential in female rabbits (Report number: 0113/173). No edema was observed after exposure of 6 rabbits to 0.5 g of the test substance applied to intact skin and covered with a semi-occlusive for 4 h. 1/6 animals showed an erythema scored with grade 1 at the 1 h and 24 h observation time point. No skin reaction was seen in this animal thereafter. No skin reactions were further observed in any other animal for any time point.
However, in a 21-day percutaneous study performed in rabbits (Report number: UCB 421/920767) conducted according to OECD 410 and under GLP conditions, the test substance caused dermal irritation at all dose levels when applied dermally for three weeks to the intact skin of male and female rabbits (100, 300 and 1000 mg/kg bw/day). Briefly, slight or well-defined erythema with or without slight or well-defined oedema were observed in rabbits of all dose groups, with the intensity and frequency being dose-dependent. The incidence of reactions was initially low at Day 7 but increased over the following two weeks and affected the majority of the rabbits. These reactions were frequently accompanied by a residual (brown) staining from the test substance and/or desquamation of the stratum corneum. Based on the observed local effects in the available short-term dermal repeated dose toxicity study (UCB 421/920767) and on human experience, the test substance is included in Annex VI of Regulation (EC) No 1272/2008 as “irritating to skin”, and is classified as skin irritating category 2, H315.
Effects on eye irritation:
A GLP-conform eye irritation/corrosion study was performed according to EPA OPP 81-4 and similar to OECD 405 to evaluate the eye irritancy potential of the test substance (Report number: 0113/174). A single dose of 30 mg test substance was instilled to the left eyes of 6 female rabbits, the right eye served as a control. The observation period was 15 days after instillation of the test item. There was no indication of a systemic effect of the treatment with the test substance. Within 1 hour after instillation of thiram substantial chemosis (score 2 – 3) and redness (score 1 – 2) of the conjunctivae were observed in all animals. The individual mean irritation scores (24 – 72 hours) of the rabbits were 0.00 for all animals for corneal opacity, 0.00, 0.67, 0.67, 0.00, 0.00, 0.00 for effects on the iris, 2.00, 2.00, 2.00, 2.67, 1.33 and 3.00 for conjunctival redness and 1.67, 2.67, 2.33, 2.0, 1.33 and 2.33 for conjunctival chemosis. These effects were fully reversible within 15 days.
According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, classification for eye irritation category 2 (H319) is warranted.
Justification for classification or non-classification
The available data on skin irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
However, based on local effects observed in a dermal 21-d repeated dose toxicity study in rabbits (UCB 421/920767) and human experience, the test substance is included in Annex VI of Regulation (EC) No 1272/2008 as “irritating to skin”. The test substance and is classified as skin irritating category 2 with the hazard statement H315.
Based on the available data on eye irritation of the test substance and according to the classification criteria of the CLP Regulation (EU) No. 1272/2008, classification for eye irritation category 2 (H319) is warranted.
The classification in regard to irritation is in line with the harmonised classification of the test substance (Annex VI of Regulation (EC) 1272/2008, index number 006-005-00-4).
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