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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-394-2 | CAS number: 3085-30-1
- 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
Upon contact with water or moisture (e.g. within mucous membranes) aluminium tributanolate hydrolyses immediately to butan-1ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species.
The skin and eye irritation of butan-1-ol was investigated in an interlaboratory study in 22 different laboratories (Weil 1971). The average outcomes were that butan-1 -ol is not irritating to the skin, but a severe eye irritant. In a test according to OECD 405, irritant effects of butan-1-ol on opacity, iris and conjunctivae appeared to be reversible within 21 days in 4 rabbits tested. Therefore the substance is considered irritating to the eye (ECETOC 1998).
Results from Lansdown (1973), a non-guideline study, indicate that repeated exposure (5 daily administrations) of a 10% aluminium hydroxide suspension did not lead to dermal irritation under the experimental conditions in mice, rabbits and pigs. Macroscopic (erythema, thickening and scaling), microscopic pathological (stained thin-sections) and histochemical examinations were carried out. No accumulation of aluminium was observed in the epidermis after application of aluminium hydroxide.
Application of 0.5 mg Aluminium nitrate to the rabbit skin during 24 hours under occlusion showed some slight irritation, not sufficient for classification as irritant (Guillot 1982). Aluminium nitrate was, however shown to be a severe eye irritant in rabbits (Guillot 1982).
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- under occlusion
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rouché SA, Couhé, France
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet/ water: no data
ENVIRONMENTAL CONDITIONS: no data
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hour (test includes a protocol with 24 hour exposure, but this is not taken into consideration)
- Observation period:
- upto 14 days (on day 1, 2, 3, 4, 7 and 14)
- Number of animals:
- 6 males/treatment
- Details on study design:
- TEST SITE
- Area of exposure: 4-6 cm2 (gauge pad moistened with water was applied to the test site)
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : after 1, 24, 48 and 72 hours and on day 7 and 14
SCORING SYSTEM:
- Method of calculation: PCI (not further specified)
- Protocols were based on OECD, AFNOR and Cosmetic regulations, which all have slightly different scoring systems - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks on result:
- no indication of irritation
- Remarks:
- based on OECD and AFNOR protocols
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed an primary cutaneous irritation index.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of a overall irritation score.
- Irritant / corrosive response data:
- The PCI was 0.36 and 0.35 for AFNOR and OECD protocols. No details provided.
For the cosmetic protocol with an exposure time of 24 hours under occlusion the substance was found slightly irritating (PCI 0.54) - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- All animals were treated with 10% aluminium hydroxide in tween 80. Mice and rabbits at a 2 cm2 area, pigs at a 4 cm2 area. 24 hours after application the animals were terminated and skins were examined visually (with a hand lens) for erythema, thickeming and scaling.
For microscopic examination (fluorescence microscopy and ordinary light microscopy), samples of treated skin were fixed in 70% ethanol for at least 18h, embedded in paraffin wax and sectioned at 5-7μm for staining with haematoxylin and eosin. Morin (dye) was used to determine the presence of aluminium (Pearse, 1960); the congo red/thioflavine T technique (Jarrett et al., 1959) was used for epidermal keratins, the DDD technique (Barrnett & Seligman, 1952) for protein-bound sulphydryl groups and Baker’s method (1944) was used for examining epidermal phospholipids. - GLP compliance:
- no
- Specific details on test material used for the study:
- Purity > 97%
- Species:
- other: rabbit, mouse and pig
- Details on test animals or test system and environmental conditions:
- mice: 5 female TFI strain from Carworth FatmStock, Raleigh, Essex, UK (8 weeks)
rabbits: 3 New Zealand White from Norfolk Rabbits Ltd., Attleborough, Norfolk UK (6 months)
pigs: 2 large white strain from Benhill, Carlehalton, Surrey UK (6 months) - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- other: Tween 80
- Amount / concentration applied:
- mice and rabbits: 0.5 mL
pigs: 1 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 h
- Number of animals:
- 5 mice, 3, rabbits and 2 pigs
- Details on study design:
- All animals were treated with 10% aluminium hydroxide in tween 80. Mice and rabbits at a 2 cm2 area, pigs at a 4 cm2 area. 24 hours after application the animals were terminated and skins were examined visually (with a hand lens) for erythema, thickeming and scaling.
For microscopic examination (fluorescence microscopy and ordinary light microscopy), samples of treated skin were fixed in 70% ethanol for at least 18h, embedded in paraffin wax and sectioned at 5-7μm for staining with haematoxylin and eosin. Morin (dye) was used to determine the presence of aluminium (Pearse, 1960); the congo red/thioflavine T technique (Jarrett et al., 1959) was used for epidermal keratins, the DDD technique (Barrnett & Seligman, 1952) for protein-bound sulphydryl groups and Baker’s method (1944) was used for examining epidermal phospholipids.
The pH of the test solutions were measured although details of the measurement method were not provided.
Additional informations to the control animals:
A negative control group received applications of distilled water.
Previous studies were referenced as evidence for the lack of irritative effects of the 0.2% Tween-80 vehicle used for the aluminium hydroxide and the basic aluminium acetate.
A series of “hydrochloric acid” control groups (5 mice per group) received administrations of dilute solutions of hydrochloric acid with pH values of 2.2, 3.0 and 4.0.
Another series of control groups (5 mice per group) received administrations of solutions of Universal buffer with pH of 2.5, 3.1, 3.4 or 4.0. - Irritation parameter:
- overall irritation score
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of a overall irritation score.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of a overall irritation score.
- Irritant / corrosive response data:
- Negative for hyperkeratosis, acanthoss. microabsesses and aluminium in keratin inall three species tested
pH of the solution was 7.2 - Interpretation of results:
- other: not irritant
- Conclusions:
- The substance does not show irritating effects to the skin of mice, rabbits and pigs after exposure for 24 hours. This is confirmed by histopathological examination
- Executive summary:
Results from Lansdown (1973), a non-guideline study, indicate that repeated exposure (5 daily administrations) of a 10% aluminium hydroxide suspension did not lead to dermal irritation under the experimental conditions. Lansdown (1973) studied the irritation effects and epidermal damage on mammalian skin (mice, rabbits and pigs) from contact exposure to six aluminium salts at concentrations ranging from 2.5% to 25%. Macroscopic (erythema, thickening and scaling), microscopic pathological (stained thin-sections) and histochemical examinations were carried out. Effects were described in relation to pH and the deposition of aluminium in the stratum corneum. Aluminium hydroxide, chloride (anhydrous), sulphate, nitrate, and basic acetate with minimum purity of 97% were applied to 2 cm2areas of shaved skin on the back of mice (TF strain, n=5) and New Zealand white Norfolk rabbits (n=3), and to 4 cm2areas of shaved skin on the back of pigs (large white strain, n=2) for 5 days. Distillled water was used as a negative control. Aluminium hydroxide (pH 7.2) was applied as a 10% suspension in 0.2% Tween-80. The author reported that previous studies had shown that Tween-80 was not an irritant to mouse skin when applied repeatedly at a concentration of 2.5% (Lansdown & Grasso, 1972). Positive results were observed for aluminium chloride and aluminium nitrate. Aluminium hydroxide, and the other salts used, did not cause any visual or microscopic irritation effects or lead to inflammatory effects on the skin of mice, rabbits or pigs. No accumulation of aluminium was observed in the epidermis after application of aluminium hydroxide. Irritation effects on application of aluminium chloride (administered at concentrations of 25%, 10%, 5% and 2.5%) were concentration-dependent and related to the amount of metal ion bound to the skin and the resulting denaturation of epidermal keratin. The pathological changes in the skin of mice treated with 25% aluminium chloride include pronounced epidermal hyperkeratosis, acanthosis with marked inter- and intra-cellular oedema and microabscess formation in the epidermis. Positive irritative effects were observed for aluminium chloride and aluminium nitrate, the two solutions that had the lowest pH values, 2.3 and 2.4, respectively. Results from solutions of hydrochloric acid and Universal buffer showed that the low pH was not the cause of irritative effects. The low pH may however have led to increased deposition of aluminium in the epidermal keratin. The histochemical results suggest that aluminium may cause denaturation of epidermal keratin. For local effects, the possible toxicity of the counter-ions, chloride and nitrate, also require consideration. The study contributes to the weight of evidence for a dermal irritative potential for aluminium if deposited in the keratin. Aluminium hydroxide did not lead to irritative effects.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- method based on US-EPA requirements
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- 8 animals were tested each receiving 4 test substances, no test on abraded skin was included
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- evaluated one hour after removal of the dressing and 48 hours thereafter (24 and 72 h)
- Number of animals:
- 8 males (> 2.0 kg)
- Details on study design:
- TEST SITE
- Area of exposure: 1 x 1 inch
- Type of wrap if used: gauze patch held in place with elastic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS
(indicate if minutes, hours or days); 24 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize (calculation of PSI by dividing sum of scores by 8) - Irritation parameter:
- other: PSI
- Basis:
- other: mean of 22 laboratories
- Time point:
- other: 24 and 72 h
- Score:
- >= 0.2 - <= 6.9
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Erythema, Edema and Necrosis are covered using a primary irritation score. No of samples with necrosis are given in the publication.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Erythema, Edema and Necrosis are covered using a primary irritation score. No of samples with necrosis are given in the publication.
- Irritant / corrosive response data:
- The conclusion in 3 labs would be severe irritant in 6 labs moderate irritant and in 7 labs mild irritant. No data on other laboratory results
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the overall evaluation of the results in 22 laboratories the substance needs to be considered as irritating to the skin
Referenceopen allclose all
In the same publication other aluminium salts were tested as solutions in water. From these test it was deducted that effects of aluminium were related to the pH of the solution and the interference with keratinocytes (see attachment for a table of the results).
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rouché SA, Couhé, France
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet/ water: no data
ENVIRONMENTAL CONDITIONS: no data - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- at 1, 24, 48, 72, 96 h and 7 days after instillation
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): additional test with washing after 4 and 30 seconds
SCORING SYSTEM: occular irritation index (Kay & Calandra)
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- >= 58.7 - <= 60.5
- Remarks on result:
- positive indication of irritation
- Remarks:
- extreme irritant
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 16.8
- Remarks on result:
- positive indication of irritation
- Remarks:
- severely irritant (rinse after 30 sec)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 1.8
- Remarks on result:
- positive indication of irritation
- Remarks:
- irritatnt (rinse after 4 sec)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritant / corrosive response data:
- The pH of a saturated solution of the substance was 0.8
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance is a severe eye irritant
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- method based on US-EPA
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- after 1 hour, 24, 72 hours and after 7 days
- Number of animals or in vitro replicates:
- 6 males (> 2.0 kg)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein staining at 24 and 72 hours and after 7 days - Irritation parameter:
- overall irritation score
- Basis:
- other: mean of 22 laboratories
- Time point:
- other: 24 h, 72 h and 7 days
- Score:
- >= 0.2 - <= 7.3
- Max. score:
- 11.2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Cornea Opacity Score, Iritis Score and Conjunctivitis Score are covered using an overall irritation score.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Cornea Opacity Score, Iritis Score and Conjunctivitis Score are covered using an overall irritation score.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Cornea Opacity Score, Iritis Score and Conjunctivitis Score are covered using an overall irritation score.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Cornea Opacity Score, Iritis Score and Conjunctivitis Score are covered using an overall irritation score.
- Irritant / corrosive response data:
- Mean irritation score after 24 h: 30.2
Mean irritation score after 72 h: 19.0
Mean irritation score after 7 days: 1.5 - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the overall mean, it can be concluded that the substance can cause severe eye damage
Referenceopen allclose all
The substance was concluded an eye irritant in 20 tests and non-irritant in 2 labs (2 questionable)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
It cannot be excluded that the results for the irritant properties as derived from the studies on aluminium nitrate are not representative for the aluminium species formed due to hydrolysis of aluminium tributanolate. As the studies with the other hydrolysis product butan-1-ol lead to classification as severe eye irritant (H318) and the harmonised classification for butan-1 -ol includes classification as skin irritant (H315), these outcomes can be considered a worst case for the classification of aluminium tributanolate,
Justification for classification or non-classification
Upon contact with water or moisture (e.g. within mucous membranes) aluminium tributanolate hydrolyses immediately to butan-1-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species.
Butan-1-ol and Aluminium 3+ species are considered not irritant to the skin, but butan-1-ol is a severe eye irritant. Therefore aluminium tributanolate needs to be classified as severe eye irritant according to
Regulation EC 1272/2008 (H318). As butan-1-ol is also classified as H315, this classification will also be applied to aluminium tributanolate in a worst case approach.
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.