Reaction mass of aluminium hydroxide and aluminium nitrate and aluminium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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: see 'Remark'

Remarks:

Guideline study with acceptable restrictions (Only raw data were reported, information on substance identity and composition is lacking and no batch no. is given. Substance identity and composition is reliability with restrictions. No Statement from company owner is received on substance identity and composition mentioned in study report).

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 401 (Acute Oral Toxicity)

Deviations:

yes

Principles of method if other than guideline:

Principles other than OECD Guideline:
- Only raw data were reported.
- Very limited reported study.
- Not always a 14 day observation period.

GLP compliance:

no

Remarks:

pre-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

Molecular formula:

Al.3/2H2O4S

IUPAC Name:

Aluminium sulphate

Details on test material:

- Name of test material (as cited in study report): aluminum sulfate solution, iron free
- Analytical purity: not reported

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: water or Tween with water

Doses:

2000, 4640 and 5000 mg/kg bw

No. of animals per sex per dose:

5 females (2000 mg/kg bw)
5 males (4640 mg/kg bw)
5 males and 5 females (5000 mg/kg bw)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: at least once
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic abnormalities (section)

Statistics:

No data

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: 5000 mg/kg bw: mild depression, ruffled fur and mild lacrimations in 5/5 male animals. All appear normal 3 days after treatment. 5000 mg/kg bw: mild depression in 5/5 female animals. However, all appear normal at the same day of treatment.

Gross pathology:

Necropsy examination revealed no substance-related findings.

Other findings:

See table below.

Any other information on results incl. tables

Date	Sex	Dose (mg/kg)	Vehicle	# deaths	Total # animals	Clinical observations	Necropsy observations
11August1976	M	4640	Tween 80 + H2O	0	5	Appear normal
8July1976	M	5000	H2O	0	5	Day 1: - Ruffled fur - Mild lacrimations Day 2 + 3: - Mild depression Following days: - Appear normal	No gross abnormalities
18June1976	F	2000	Tween 80 + H2O	0	5	Appear normal
13July1976	F	5000	H2O	0	5	Day 1: - Mild depression Following days: - Appear normal	No gross abnormalities

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

This study was performed with some equivalence to OECD Guideline 401 (Acute Oral Toxicity). However, not according to GLP standards.

The test material was evaluated for its acute oral toxicity potential in rats when administered as oral doses at levels of 2000 mg/kg bw in Tween/water to females, 4640 mg/kg bw in Tween/water to males and 5000 mg/kg bw in water to males and females. No mortality occurred. No clinical changes were observed at 2000 and 4640 mg/kg dose levels. At 5000 mg/kg clinical signs of toxicity included mild depression and ruffled fur. All appeared normal after 1 (females) or 3 males) days.

The acute oral median lethal dose to rats of aluminum sulphate was found to be greater than 5000 mg/kg bodyweight for males and females. Therefore the test material is not classified, according to OECD-GHS.