Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions Al3+is the predominant aluminium form at low pH (less than 5.5). As pH increases above 5.5, aluminium-hydroxide complexes formed by hydrolysis become increasingly important and dominate aqueous aluminium speciation . Al3+, depending on the composition of the medium and pH, may form Al(OH)3 or Al2O3 or AlCl or AlNO3 or AlSO4. According to the solubility studies, the major elements found at the maximum solubility are 1054 mg/l Al and 856 mg/l Ca, for 100 g of the tested substance, ie approximatively 1%. By oral route, Aluminium chloride could be formed in the stomach, thus a read-across was made with this salt.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 422 "Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test
Deviations:
yes
Remarks:
: Temporary deviations from the maximum level of relative humidity occurred; acclimatization period was shorter due to the late delivery of animals; Age of animals was 9 and 11 weeks instead of recommended 12 weeks
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Reference substance name:
Aluminium chloride basic
IUPAC Name:
Aluminium chloride basic
Constituent 2
Reference substance name:
Aluminum chloride, basic
EC Number:
215-477-2
EC Name:
Aluminum chloride, basic
Cas Number:
1327-41-9
IUPAC Name:
aluminum trichloride
Details on test material:
- Name of test material (as cited in study report): Al(OH)13Cl17(in aqueous solution)
- Molecular weight (if other than submission substance): 109.36
- Composition of test material, percentage of components: Al (Al2O3) - 17.0%; Aluminium - 9.0%; Chloride - 19.9%; Arsenic < 0.1 mg/kg; Lead - 0.17 mg/kg; cadmium < 0.01 mg/kg; Chromium -0.29 mg/kg; Nickel - 0.36 mg/kg; Mercury < 0.01 mg/kg; Selenium < 0.1 mg/kg; Antimony < 0.1 mg/kg bw
- Physical state: yellow liquid
- Lot/batch No.: 5-510-37
- Expiration date of the lot/batch: 29 January 2006
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Other:
Specific gravity: 1.36 g/cm³
pH: 1 at concentration of 100 M-%
Stability in vehicle/water: at least 48 hours
Solubility in water: 1-100%

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
LOAEL
Remarks:
(rat, irritation of stomach mucosa)
Effect level:
1 000 mg/kg bw (total dose)
Basis for effect level:
other: effect type not specified

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The full study is reported in section 7.8.1. Please refer to it