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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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
EC Number:
402-370-2
EC Name:
(ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
Cas Number:
149057-70-5
Molecular formula:
C14H28AlNO6
IUPAC Name:
octaaluminium(3+) octakis((2Z)-4-ethoxy-4-oxobut-2-en-2-olate) octakis(1-methoxypropan-2-olate) octakis(2-(dimethylamino)ethan-1-olate)
Details on test material:
no detail on substance purity

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Five male and five female Sprague-Dawley CFY strain rats were supplied by Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire. At the start of the main study the males weighed 178 - 194g, and the females 155 - 163g, and were approximately five to eight weeks old. After a minimum acclimati-sation period of five days the animals were selected at random and given a unique number within the study by ear punching and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor poly-propylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 - 21°C and relative humidity of 40 - 48%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calcu-lated according to its fasted bodyweight at the time of dosing.
Doses:
a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
A group of ten rats (five males and five females) was dosed. All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calcu-lated according to its fasted bodyweight at the time of dosing.
Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation.
Individual bodyweights were recorded on the day of treatment (day O). and on days 7 and 14.
All animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Statistics:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death was observed : The acute oral median lethal dose (LD50) of the test material was therefore considered to be greater than 2000 mg/kg bodyweight. The acute oral median lethal dose (LD50) of the test material was therefore considered to be greater than 2000 mg/kg bodyweight.
Clinical signs:
No evidence of systemic toxicity was noted during the study period.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material, ALUMINIUM ALKOXIDE Al/1/0, BATCH NUMBER 8/10/87PR was found to be greater than 2000 mg/kg bodyweright. No symbol and  risk phrase are therefore (require according to EEC regulations)
Executive summary:

In an OECD 401 study in 10 male and female rats, the acute oral median lethal dose (LD50) of the test material, ALUMINIUM ALKOXIDE Al/1/0, BATCH NUMBER 8/10/87PR was found to be greater than 2000 mg/kg bodyweight. No symbol and  risk phrase are therefore (require according to EEC regulations).