Dialuminium chloride pentahydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Information on substance identity is not based on CAS 12042-91-0. Composition is not available. NON - Guideline study. Non- GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

See overall remarks

Principles of method if other than guideline:

Not relevant

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Locron P
- Physical state: Solid
- Molecular formula (if other than submission substance): Al2(OH)5Cl.2-3H2O

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF-Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breed
- Weight at study initiation: 102 g (80 - 137 g)
- Fasting period before study: 16 hours
- Housing: Plastic cages filled with sawdust
- Diet (e.g. ad libitum): Altromin 1324 (of the company Altrogge in Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: test concentrations: 25%

Doses:

6300, 8000, 10000 and 15000 mg/kg body weight

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, macroscopic observations, section (on dead aninals)

Statistics:

LD50 values were calculated according using Probit analysis (after Linder & Weber). Confidence intervals were calculated according to Cavalli-Sforza.

Results and discussion

Preliminary study:

Not relevant

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

9 187 mg/kg bw

95% CL:

ca. 8 383 - ca. 10 067

Mortality:

6300 mg/kg bw: 0 out of 10
8000 mg/kg bw: 2 out of 10
10000 mg/kg bw: 7 out of 10
15000 mg/kg bw: 10 out of 10

Clinical signs:

other: Affected animals showed difficulties with breathing and a disturbed equilibrium.

Gross pathology:

Deceased animals showed reddening of the stomach and intestinal slime layer. Surviving animals did not show macroscopic abberations.

Other findings:

No data

Any other information on results incl. tables

See attached full study report for raw data.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the LD50 of Locron P towards female SPF-Wistar rats is 9187 mg/kg bw therefore it is not classified according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

The toxicity of Locron P towards female SPF-Wistar rats was investigated in an acute oral toxicity study comparable in methodology to OECD Guideline 401. The substance was administered to groups of ten animals at concentrations of 6300, 8000, 10000 and 15000 mg/kg bodyweight followed by a 14 -day post-dosing observation period.

Mortality was observed at 8000, 10000 and 15000 mg/kg bw: 2/10, 7/10 and 10/10, respectively. Affected animals showed difficulties with breathing and a disturbed equilibrium. Deceased animals showed reddening of the stomach and intestinal slime layer. Surviving animals did not show macroscopic abberations.

Under the test conditions, the LD50 of Locron P was found to be 9187 mg/kg bw (8383 - 10067 mg/kg bw) therefore it is not classified according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.