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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:
supporting study
Study period:
7-01-1986 till 21-01-1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Statement is provided for Identity of the test substance - no CAS number or other identification is in report. GLP. OECD 401 study. Available CoA Aluminium Chlorohydrate, USP, spec No BH-0450, data May 15, 2007 wich supersedes CoA Sep 2004
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): Hydrochlor ultrafine
- Physical state: Solid
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Limited, Wyton, Huntingdon.
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: males: 120 - 134 g; females: 120 - 129 g
- Fasting period before study: overnight fasting before application, 2 hours fastinf after application
- Housing: propylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and mouse expanded diet No. 1, Special diet services limited, Witham, Essex, UK
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 degrees celsius
- Humidity (%): 45 - 60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage): 4 ml/kg bw
- Justification for choice of vehicle: substance is water soluble
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy examination for macroscopic abnormalities
Statistics:
No data

Results and discussion

Preliminary study:
No data.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed
Clinical signs:
All animals showed hunched posture, pilo-erection, lethargy and a decreased respiratory rate one hour after treatment. Other signs consisted of ataxia, increased salivation, ptosis and staining around the mouth and snout after 4 hours and on day 1. After day 2 all animals were normal.
Body weight:
Normal body weight gains were recorded during during the study period.
Gross pathology:
Congestion was observed in the lungs of two rats, no abnormalities were observed in any of the remaining animals.
Other findings:
No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of this study, the acute oral median lethal dose to rats of Hydrochlor ultrafine was found to be greater than 2000 mg/kg bw.Based on these results, the test substance is not classified according to the Regulation (EC) N° 1272-2008 (CLP) and the GHS.
Executive summary:

In an acute oral toxicity study performed according to OECD Guideline 401 and in compliance with GLP, groups (5/sex/dose) of Sprague-Dawley rats were given Hydrochlor ultrafine at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred. No significant clinical signs were observed. At necropsy, congestion was observed in the lungs of two rats, no abnormalities were observed in any of the remaining animals.

The acute oral LD50 for was found to be greater than 2000 mg/kg bw. Based on these results, the test substance was not classified according to the Regulation (EC) N° 1272-2008 (CLP) and the GHS.