Aluminum alkyl acetate glycol complexes

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Method of administration:
Gavage

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

Test duration: 90 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 10 animals at 50 mg/kg bw/day
Male: 10 animals at 250 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 50 mg/kg bw/day
Female: 10 animals at 250 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:

Clinical observations:
No significant clinically observable signs of toxicity were
detected.


There were no deaths and no treatment related effects on
behavior, functional performance, sensory reactivity,
bodyweight, or food or water consumption.

Laboratory findings:
There were no significant treatment related changes detected
in the haematological parameters measured or in blood
chemistry.

Effects in organs:
No significant treatment related organ weight changes were
detected.


No macroscopic abnormalities were detected at terminal kill.


Trachea: Epithelial deciliation, epithelial hyperplasia and
inflammatory cell infiltration were observed in animals of
either sex treated with 250 mg/kg/day. These and associated
changes are probably a consequence of accidental
instillation into the airways and are unlikely to be a
systemic effect.


Stomach: Agglomeration of secretion was observed in the
gastric mucosa of both sexes treated with 1000 mg/kg/day.
Acanthosis and hyperkeratosis of the epithelium of the
forestomach were also observed. Similar effects were not
seen convincingly at other dose levels.


A malignant tubular carcinoma was observed in the kidney of
one 1000 mg/kg/day female. Due to a lack of any other
findings in the kidneys of other animals this is not
considered to be treatment related effect.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

250 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

50 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

No clinically observable signs of toxicity were detected. There were no deaths, and no treatment-related effects on behaviour, functional performance, sensory reactivity, bodyweight, or food and water consumption.

There were no treatment-related changes detected in the haemaotlogical parameters measured, or in blood chemistry. There were no ocular changes noted by opthalmoscopy.

No treatment-related organ-weight changes were detected. No macroscopic abnormalities were detected at terminal kill.

Trachea: Epithelial deciliation was observed in animals of either sex treated with 1000 mg/kg/day, and for males treated with 250 mg/kg/day. These, and associated changes, are probably a consequence of accidental installation into the airways, and are unlikely to be a systemic effect.

Stomach: Agglomeration of secretion was observed in the gastric mucosa of both sexes treated with 1000 mg/kg/day. Acanthosis and hyperkeratosis of the epithelium of the forestomach were also observed. Similar efects were not seen convincingly at other dose levels.

Applicant's summary and conclusion

Conclusions:

Classified as: Not classified.
Exclusion of the findings associated with irritancy would result in a NOAEL of 1000 mg/kg/day.