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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

Published guideline-comparable studies of the acute oral toxicity of with aluminium nitrate are available in the rat and mouse.  No data are presented for acute inhalation toxicity; a waiver is provided for thie endpoint.  An acute dermal toxicity study performed with the read-across substance aluminium sulphate is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study; detailed findings not reported but data considered adequate for LD50 determination and hazard classification purposes.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: detailed findings not reported
Principles of method if other than guideline:
Guideline-comparable assessment of the oral LD50 in the rat. LD50 results are reported as part of a preliminary investigation into the assesment of efficacy of chelating agents
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna Iberica (Barcelona, Spain)
- Weight at study initiation: 230-280 g
- Diet: ad libitum, Standard pellet diet (Source: Panlab, Barcelona, Spain)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
no data
Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
The concentrations were adjusted so that a 250 g rat received 1 ml.
Doses:
No data
No. of animals per sex per dose:
3 males and 3 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: not specified
- Other examinations performed: not specified
Statistics:
The LD50 value was calculated according to the method of Litchfield & Wilcoxon (1949).
Preliminary study:
LD50 values were established as part of a preliminary investigation into the assesment of efficacy of chelating agents.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 060
Based on:
other: anhydrous salt equivalent
95% CL:
>= 1 760 - <= 2 407
Remarks on result:
other: Calculated based on Al3+ content in anhydrous aluminium nitrate
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 263 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 103 - <= 4 248
Remarks on result:
other: Reported value for the test material: aluminium nitrate nonahydrate
Sex:
male/female
Dose descriptor:
LD50
Effect level:
261 mg/kg bw
Based on:
element
Remarks:
: Al
95% CL:
>= 223 - <= 305
Remarks on result:
other: Reported value for Al3+ equivalents
Mortality:
no data presented
Clinical signs:
other: no data presented
Gross pathology:
no data presented
Other findings:
no data

The acute oral LD50 of aluminium nitrate nonahydrate in the rat was reported to be 3622 mg/kg bw; equivalent to 261 mg/kg bw Al; equivalent to 2060 mg/kg bw anhydrous aluminium nitrate

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of anhydrous aluminium nitrate in the rat was calculated to be 2060 mg/kg bw.
Executive summary:

LD50 values for aluminium nitrate were established as part of a preliminary investigation into the assesment of efficacy of chelating agents. The acute oral LD50 of aluminium nitrate nonahydrate in the rat was reported to be 3622 mg/kg bw; equivalent to 261 mg/kg bw Al; equivalent to 2060 mg/kg bw anhydrous aluminium nitrate

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 060 mg/kg bw
Quality of whole database:
Published guideline-comparable studies with aluminium nitrate are available in the rat and mouse

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline-comparable study with some minor deviations
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
:only raw data and limited study information reported. Only 2 males and 2 females tested.
GLP compliance:
no
Remarks:
: study pre-dates mandatory GLP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
2 males and 2 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: at start and end of the test
- Necropsy of survivors performed: yes
Statistics:
No data
Preliminary study:
Not relevant
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality at 5000 mg/kg bw
Mortality:
No mortality occurred following treatment and during the observation period at the 5000 mg/kg dosage level.
Clinical signs:
other: Clinical observation data at the 5000 mg/kg dosage: - Males: mild/moderate erythema. Both appear normal 2 days after treatment. - Females: moderate and severe erythema, small areas of haemorrhaging in places where large chunks of compound were pressed int
Gross pathology:
Animals in the 5000 mg/kg group showed no gross abnormalities during necropsy, with the exception of 1 male animal which had pale lungs.
Other findings:
No data

The acute dermal LD50 of the read-across substance aluminium sulphate was found to be >:5000 mg/kg bw in the rabbit

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the read-across substance aluminium sulphate was found to be >:5000 mg/kg bw in the rabbit
Executive summary:

The read-across substance aluminium sulphate hydrate was evaluated for its acute dermal toxicity potential in New Zealand White rabbits. The study is equivalent to the OECD Guideline 402 (Acute Dermal Toxicity) with deviations. For 24 hours, 5000 mg/kg bw test substance was applied to the skin of 2 male and 2 female rabbits. This application produced some skin irritation such as erythema and haemorrhaging after treatment. No mortality occurred. All rabbits exhibited normal appearance and behaviour on Day 2. The gross necropsy showed no significant gross changes attributable to treatment. The acute dermal LD50 in the rabbit was found to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Guideline-comparable read-across study.

Additional information

Acute oral toxicity

LD50 values for aluminium nitrate were established as part of a preliminary investigation into the assesment of efficacy of chelating agents (Llobet et al, 1987). The acute oral LD50 of aluminium nitrate nonahydrate in the rat was reported to be 3622 mg/kg bw; equivalent to 261 mg/kg bw Al; equivalent to 2060 mg/kg bw anhydrous aluminium nitrate. The acute oral LD50 of aluminium nitrate nonahydrate in the mouse was reported to be 3980 mg/kg bw; equivalent to 286 mg/kg bw Al; equivalent to 2257 mg/kg bw anhydrous aluminium nitrate

Acute inhalation toxicity

A study of acute inhalation toxicity is waived in accordance with Column 2 of Annex VIII of the REACH Regulation, based on the physicochemical properties of the substance. The substance is a non-volatile solid with a large particle size and is most frequently supplied in aqueous solution.

Acute dermal toxicity

A study of acute dermal toxicity is available for the read-across substance aluminium sulphate (Scholler, 1976). No mortality was seen at the limit dose of 5000 mg/kg bw/d. Similarly low acute dermal toxicity can be predicted for aluminium nitrate, based on the results of this study and also taking into account the low acute oral toxicity seen in two species.


Justification for selection of acute toxicity – oral endpoint
Study in the preferred species (rat), reporting the lowest LD50 value

Justification for selection of acute toxicity – dermal endpoint
Only one study available for this endpoint

Justification for classification or non-classification

Available data for acute oral and dermal toxicity do not trigger classification of aluminium nitrate according to the CLP Regulation (Regulation (EU) No. 272/2008) or the Dangerous Substances Directive (67/548/EEC).