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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 March 2017 - 5 September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminum hydroxide diacetate monohydrate
Cas Number:
80164-67-6
Molecular formula:
C4H7AlO5 H2O
IUPAC Name:
Aluminum hydroxide diacetate monohydrate
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 9 weeks at start of treatment
- Weight at study initiation: 145- 168 g
- Fasting period before study: Diet was withheld from about 17 to 20 hours before start of treatment until 4 hours after administration.
- Housing: individually
- Diet (ad libitum): maintenance diet (V1534, ssniff Spezialdiaten GmbH, Germany)
- Water (ad libitum): tap water from the community water supply
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 - 23.2
- Humidity (%): 42.9 – 60.6
- Air changes (per hr): not specified, fully air conditioned room
- Photoperiod: not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.25 % aqueous hydroxypropylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the chemical properties of the test item, mortality was not expected at the highest starting dose of 2000 mg/kg.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 (2 x 3)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily, weighing: before treatment (day 1) and on day 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen.
Clinical signs:
other: No clinical signs of toxicity were observed.
Gross pathology:
No organ alterations were identified during the gross pathological examination.
Other findings:
No other findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It can be assumed that the experimental result for the test item is also valid for the anhydrous test item. Under the conditions of the present study, the test item has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats. The calculated LD50 value of the anhydrous test item is higher than 1800 mg/kg bw.
Executive summary:

The objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was started with 2000 mg/kg in 3 female rats and continued with further 3 females treated with 2000 mg/kg.

Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

No mortality occurred during the course of this study. No clinical signs of toxicity were observed. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.

It can be assumed that the experimental result for the test item is also valid for the anhydrous test item. Under the conditions of the present study, the test item has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats. The calculated LD50 value of the anhydrous test item is higher than 1800 mg/kg bw.