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Toxicological information

Acute Toxicity: oral

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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

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:
Affected animals showed difficulties with breathing and a disturbed equilibrium.
Body weight:
Animals at higher doses had lower bodyweights than animals at lower doses. it is not indicated whether this difference is significant.
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.