Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles
Justification for type of information:
The substance is sparinglly soluble in water. The main component is metallic alumina. Read-across from Al3+ ion to Al metallic is justified.

Data source

Reference
Reference Type:
publication
Title:
Propolis protection from reproductive toxicity caused by aluminium chloride in male rats
Author:
Yousef, M. I. and Salama, A. F.
Year:
2009
Bibliographic source:
Food and Chemical Toxicology 47: 1168-1175

Materials and methods

Principles of method if other than guideline:
Evaluation of reproductive toxicity of aluminium chloride AlCl3 in male rats
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Aluminium chloride
EC Number:
231-208-1
EC Name:
Aluminium chloride
Cas Number:
7446-70-0
IUPAC Name:
aluminum trichloride
Details on test material:
- Name of test material (as cited in study report): aluminium chloride
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on mating procedure:
not applicable
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
70 days
Frequency of treatment:
once daily
Details on study schedule:
After two weeks of acclimation, animals were divided into four equal groups. Rats were orally administered their respective doses every day for 70 days. The duration of the experiments lasts for 70-day for completion of the spermatogenic cycle and maturation of sperms in epididymis.
Doses / concentrations
Remarks:
Doses / Concentrations:
34 mg AlCl3/kg bw (1/25 LD50) corresponding to 6.9 mg Al/kg bw/day
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
LOAEL
Effect level:
6.9 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: testicular dysfunction

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

AlCl3 caused a decrease in testes, seminal vesicle and epididymis weights, sperm concentration, motility, testosterone level and the activities of 17 -ketosteroid reductase, CAT and GST, and GSH content. While, dead and abnormal sperm and testes TBARS concentrations were increased. Histopathologic examinations revealed apparent alterations in the testes, where it induced marked lesions in seminiferous tubules.

Applicant's summary and conclusion

Conclusions:
The present results showed that aluminium chloride caused testicular dysfunction, and deterioration in semen quality and testosterone levels. Also, itincreased the lipid peroxidation and decreased the antioxidant enzymes and glutathione in testes.