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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

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.

The acute oral toxicity of butan-1-ol in rat as expressed as LD50 is between 2510 and 4360 mg/kg bw (Jenner 1964, Smyth 1951). For aluminium nitrate and aluminium tri-isopropanolate oral LD50 values of 4280 mg/kg and 11300 mg/kg bw are reported (Smyth 1969).

For acute inhalation toxicity a LC50 of > 24.3 mg/L for butan-1-ol and a LC50 of 888 mg/m3 for aluminium flakes were derived (Korsak 1994, Reynolds 1986).

The dermal LD50 for butan-1-ol in rabbits is between 4200 and 5300 mg/kg bw (Patty 1982).

Butan-1-ol is not toxic via the dermal route, but is classified as harmful after swallowing (according to Annex VI of Regulation (EC) No 1272/2008). In several inhalation studies (not reported here) butan-1-ol showed local irritant effects on the respiratory system and transient effects on the CNS (drowsiness and dizziness) and is therefore classified as STOT SE 3, H335/H336 (according to Annex VI of Regulation EC 1272/2008).

Aluminium species (hydroxide or oxide) that may be formed during hydrolysis are not classified for acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
No details available
GLP compliance:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 360 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 980 - <= 4 780
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 in rats is 4360 mg/kg bw
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: done but not specified
No additional details provided
Statistics:
LD50 by Litchfield & Wilcoxon
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 510 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 220 - <= 2 840
Mortality:
death occurred between 4 and 18 hours post-dosing
Clinical signs:
other: Depression, coma
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the substance in rats is 2510 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 510 mg/kg bw
Quality of whole database:
Based on the available study on the hydrolysis product butan-1-ol

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
purpose of the investigations was to asses behavioural effects
GLP compliance:
not specified
Test type:
traditional method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Imp: DAK
- Weight at study initiation: 250-300 g

ENVIRONMENTAL CONDITIONS: no data
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation chamber (1.3 m3)
- Generation: by heating of liquid substance in washer

TEST ATMOSPHERE
- Brief description of analytical method used: GC with FID
- Samples taken: every 30 min
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
ca 3500, 5750 and 7900 ppm (10.8, 17.7 and 24.3 mg/L)
No. of animals per sex per dose:
10 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: behavioural tests were performed immediately after the 4 hours exposure period
- Examinations performed:rotarod performance, hot plate performance

Rotarod performance was trained before exposure and only rats that were succesful in at least 10 trials were included in the study. Rotarod performance was measured before exposure and immediately therafter in 10 rats.
Hot plate perfomance was measured as latency to react immediately after exposure in 10 rats.
Statistics:
Probit (EC50), ANOVA and Kruskall-Wallis
Sex:
male
Dose descriptor:
other: EC50 rotarod
Effect level:
23.2 mg/L air
Based on:
test mat.
95% CL:
>= 19.5 - <= 29.2
Exp. duration:
4 h
Remarks on result:
other: 7559 ppm
Sex:
male
Dose descriptor:
other: EC50 hot plate test
Effect level:
18.2 mg/L air
Based on:
test mat.
95% CL:
>= 14.9 - <= 22.3
Exp. duration:
4 h
Remarks on result:
other: 5901 ppm
Sex:
male
Dose descriptor:
LC50
Effect level:
> 24.3 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no maortality at any of the concentrations tested
Interpretation of results:
GHS criteria not met
Conclusions:
The LC 50 of the substance is > 24.3 mg/L. Below this concentration behavioural effects on rotarod performance and hot plate test are observed.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
24 300 mg/m³ air
Quality of whole database:
Based on the available study on the most volatile hydrolysis product butan-1-ol

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
standard work on toxicology
Qualifier:
no guideline followed
Principles of method if other than guideline:
no details provided
GLP compliance:
not specified
Test type:
standard acute method
Species:
rabbit
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 200 mg/kg bw

An additional result in the same publication gave an LD50 of 5300 mg/kg bw in rabbits

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 in rabbits is between 4200 and 5300 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 200 mg/kg bw
Quality of whole database:
Aluminium hydroxide, aluminium oxide, aluminium oxyhydroxide are insoluble in water. Due to their insolubility it can be assumed that the absorption of these aluminium compounds via the skin will be limited. Therefore the LD50 is based on the other hydrolysis product butan-1-ol

Additional information

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.

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. Aluminium species are not classified for acute toxicity, but butan-1 -ol is classified as harmful after swallowing and as STOT SE 3, H335/H336 (according to Annex VI of Regulation EC 1272/2008). Therefore aluminium tributanolate will be classified as H302, H335 and H336 in a worst case approach.