Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium

EC Number:

236-109-7

EC Name:

Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium

Cas Number:

13170-05-3

Molecular formula:

C22H27AlO5

IUPAC Name:

aluminum hydroxide bis(4-tert-butylbenzoate)

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

no details given

Test animals

Species:

mouse

Strain:

other: Kuming mice

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shanghai SLAC Laboratory Animal Co., Ltd. (Production License: SCXK (Hu) 2007-0005. Animal Use License: SYXK (Hu) 2007-0008).
- Age: 4-5 weeks old
- Weight at study initiation: The body weight range of male mice was 19 - 22 g, and that of female mice was 19 - 22g.
- Housing: Animals were housed in the suspended cages (L46xW31xH20cm) by their sex, 10 animals per cage. Cages were replaced twice weekly.
- Diet (e.g. ad libitum): laboratory diet was provided by Suzhou Shuangshi Laboratory Animal Feed Science and Technology Ltd. (Production License: Su (E) Sishengzi (2002) 006).
- Water (e.g. ad libitum): Laboratory drinking water was offered for free access. The water meets the Chinese "Hygiene standard for drinking water" (GB5749-2006).
- Fasting period before study: 16 hours


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
According to the data supplied by the sponsor, the test substance is insoluble in water. But this powder could be dissolved in corn oil to form a suspension liquid. Then the suspension can be mixed homogeneously for administrating.
According to the request of the limit test, 5000mg of the test substance were weighed, and dissolved into corn oil to 20ml. The solution was mixed evenly for future use.

MAXIMUM DOSE VOLUME APPLIED: Test substance was administered to the mice via a single oral gavage. The gavage volume was 0.4 ml per 20 g body weight.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5000mg/kg bw: 10 female mice, 10 male mice

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (5000 mg/kg bw)
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality and viability, histopathology, body weights were recorded once a week prior to administration and after administration.

Statistics:

According to the mortality number of each dose group, the median lethal dose (LD50) and 95% confidence limit of this acute oral toxicity study in mice was calculated.

Results and discussion

Preliminary study:

After administration, no obvious toxicity symptoms were observed.
Results of death in preliminary test: No death was observed in this study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

5000 mg/kg bw: 0/10

Clinical signs:

other: no toxicity symptoms detected

Gross pathology:

no abnormalities detected

Other findings:

Macroscopic findings: No pathological changes were observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute oral toxicity study: The acute oral LD50 of the test substance for male and female mice was both greater than 5,000 mg/kg.
Toxicity classification: virtually non toxic.

Executive summary:

Acute oral toxicity was analyzed in a study performed in large part equivalent to method described in OECD guideline 401.

The test substance, Bis(4-(tert-butyl)benzoate-0) hydroxyaluminium (CAS No. 13170-05-3), was used to perform the acute oral toxicity study in mice. The test substance was suspended in corn oil. The dose of 5,000 mg/kg was administrated to male and female mice, respectively (10 male and 10 female mice). The sample solution was administered to all mice by a single oral gavage. The gavage volume was 0.4 ml per 20 g body weight. All animals were examined for clinical observation, mortality and viability after treatment on daily basis for 14 days. Body weights were recorded once a week prior to administration and after administration.

After administration, no toxicological symptoms and mortality were observed in mice. No abnormal change was observed among organs of animals after observation period.

The acute oral LD50 of the test substance for male and female mice was both greater than 5,000 mg/kg. Toxicity classification: virtually non-toxic.