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EC number: 700-992-1 | CAS number: -
- 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
Acute irritation studies in the rabbit show very slight effects on skin and eyes shortly after application of the test substance, only, which did not meet GHS criteria.
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:
- 09. Sept. 1986 - 15. Sept. 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report, which meets basic scientific priniciples
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Kleine weiße Russen, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3 - Duration of treatment / exposure:
- Exposure: 4 hours
- Observation period:
- 1, 24, 48, 72 hours, and 6 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze and polyethylene foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the described test conditions, only slightly irritating effects were recorded early after application, which were reversible. However, the observations did not meet GHS criteria and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
- Executive summary:
In an acute skin irritation /corrosion study 0.5 cm3 of Tetrabutan (dest.) was applied onto the shaved skin of 3 rabbits (Kleine weiße Russen, ChBB-SPF, Dr. Karl Thomae GmbH, Biberach). Exposure was occlusive for 4 hours. Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 404, after 1 h, 24h, 48h, 72h, and 6 days.
During the observation period all animals showed erythema (score 2) and edema (score 1 or 2) at 1 hour after exposure. Symptoms decreased over time and were complete reversible after 6 days.
Reference
Animals |
1h |
24h |
48h |
72h |
6 days |
|||||||
|
|
|
Eryth. |
Edem. |
Eryth. |
Edem. |
Eryth. |
Edem. |
Eryth. |
Edem. |
Eryth. |
Edem. |
1 |
18701 |
male |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
18883 |
male |
2 |
1 |
2 |
1 |
1 |
0 |
x1 |
0 |
0 |
0 |
3 |
18895 |
male |
2 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mean |
|
3.33 |
1.67 |
0.67 |
0.33 |
0 |
||||||
Irritation index (72h) |
1.5 |
|
Eryth.: Erythema
Edem.:Edema
x: blotched
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:
- 09. Sept. 1986 - 15. Sept. 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report, which meets basic scientific priniciples
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Kleine weiße Russen, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3 - Duration of treatment / exposure:
- - exposure: 72 h
- Observation period (in vivo):
- up to 6 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological NaCl solution
- Time after start of exposure: 72 hours after application
SCORING SYSTEM: scoring system according to Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- AVERAGE SCORE 1 h/24 h/48 h/72 h/ 6 days
- Cornea: 0.0/0.0/0.0/0.0/0.0
- Iris: 0.0/0.0/0.0/0.0/0.0
- Conjunctiva: 1.0/0.0/0.0/0.0/0.0
Descripton of effects: redness of conjunctiva in all 3 animals 1 hour after application - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed very slight signs of irritation shortly after application of the test substance only, which did not meet GHS criteria. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
- Executive summary:
In an eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits (Kleine weiße Russen, Chbb-SPF, Dr. Karl Thomae GmbH, Biberach). Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 405.
During the observation period the animals showed redness of the conjunctivae only 1 hour after application. No other symptoms were observed. In this study, Tetrabutan (dest.) is not irritating to eyes based on the mean values of ocular reactions at 24, 48, and 72 hours.
Reference
In an eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits (Kleine weiße Russen, Chbb-SPF, Dr. Karl Thomae GmbH, Biberach). Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 405.
During the observation period the animals showed redness of the conjunctivae only 1 hour after application. No other symptoms were
observed. In this study, Tetrabutan (dest.) is not irritating to eyes based on the mean values of ocular reactions at 24, 48, and 72 hours.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute skin irritation /corrosion study, 0.5 cm3 of Tetrabutan (dest.) was applied onto the shaved skin of 3 rabbits under an occlusive dressing for 4 hours. Animals were then observed for 6 days. Irritation was scored by the Draize scheme after 1, 24, 48 and 72 hours and 6 days. During the observation period all animals showed erythema (score 2) and oedema (score 1 or 2) at 1 hour after exposure. Reactions decreased over the following 72-hour period, and were completely resolved by Day 6.
In an acute eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits, and observed for 6 days. Irritation was scored using the Draize scheme. During the observation period, the animals showed redness of the conjunctivae at the 1 hour examination. No other irritation responses were observed.
Justification for classification or non-classification
In an acute skin irritation study, the mean scores for erythema and oedema at the 24, 48 and 72 hour examinations for three animals were below the classification threshold for irritancy, and in an acute eye irritation study, effects of treatment were confined to transient redness of the conjunctivae at the 1 hour examination.
Tetrabutan is therefore classified as non-irritant to skin and eyes, according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008
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