Aluminium nitrate

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium sulphate

EC Number:

233-135-0

EC Name:

Aluminium sulphate

Cas Number:

10043-01-3

IUPAC Name:

aluminium sulphate

Constituent 2

Reference substance name:

Aluminum sulphate, hydrate

IUPAC Name:

Aluminum sulphate, hydrate

Test material form:

other: granular

Details on test material:

- Name of test material (as cited in study report): Aluminum Sulfate, Hydrate
- Physical state: granular, no further information
- Analytical purity: no information
- Impurities (identity and concentrations): no information
- Composition of test material, percentage of components: no information
- Lot/batch No.: no info; the sample was received on July 10, 1975
- Stability under test conditions: no information
- Storage condition of test material: no information

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

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

Results and discussion

Preliminary study:

Not relevant

Effect levels

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.