Registration Dossier
Registration Dossier
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EC number: 233-141-3 | CAS number: 10043-67-1
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: peer-reviewed report
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- PRIORITY SUBSTANCES LIST ASSESSMENT REPORT FOLLOW-UP TO THE STATE OF SCIENCE REPORT, 2000 Aluminum Chloride Aluminum Nitrate Aluminum Sulphate
- Author:
- Environment Canada Health Canada
- Year:
- 2 010
- Bibliographic source:
- Environment Canada Health Canada
- Reference Type:
- publication
- Title:
- A preliminary study of the dermal absorption of aluminium from antiperspirants using aluminium-26.
- Author:
- Flarend R, Bin T, Elmore D, Hem SL.
- Year:
- 2 001
- Bibliographic source:
- Food Chem Toxicol 39(2): 163- 168.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Deviations:
- not specified
- Principles of method if other than guideline:
- In the study of Flarend et al. (2001), 26-Al-chlorohydrate (aluminum complex inantiperspirant) was applied to a single underarm of one man and one woman.:Aluminium chlorohydrate (ACH), the active ingredient in many antiperspirants, was labelled with the radioisotope 26Al. The labelled ACH was then fractionated into about 100 samples using gel filtration chromatography. Each fraction was analyzed for 26Al and total aluminium content. Aluminium-26 was only detected in the fractions that also contained aluminium, which verified that the ACH was uniformly labelled. 84 mg of the labelled ACH was then applied to a single underarm of two adult subjects with blood and urine samples being collected over 7 weeks. Tape-stripping and mild washings of the skin were also collected for the first 6 days.5 - 7.5 % Al concentration, daily exposure 50 - 75 mg Al.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Aluminium chlorohydrate
- IUPAC Name:
- Aluminium chlorohydrate
Constituent 1
Test animals
- Species:
- other: human
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- other: single underarm
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- 5 - 7.5 % Al concentration, daily exposure 50 - 75 mg Al
- Duration of treatment / exposure:
- 43 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:5 - 7.5 % Al concentration, daily exposure 50 - 75 mg Al Basis:other: 5 - 7.5 % Al concentration, daily exposure 50 - 75 mg Al
Examinations
- Observations and examinations performed and frequency:
- cumulative urinary excretion
Results and discussion
Results of examinations
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 15% of the total absorbed dose of 6 - 9 µg Al/day = 0.9 - 1.35 µg Al/day or for a 70 kg worker 0.013 - 0.019 µg Al/kg bw/day.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 85% of the total absorbed dose of 6 - 9 µg Al/day are excreted via urine: 5.1 - 7.65 µg Al/day or for 70 kg worker 0.07 - 0.11 µg Al/kg bw/day.
- Details on results:
- No adverse effects were reported.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 0.71 - <= 1.07 mg/kg bw/day (nominal)
- Based on:
- other: as Aluminium
- Sex:
- male/female
- Basis for effect level:
- other: Calculated from experimental results from daily exposure of 50 until 75 mg/day and a 70 kg worker.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The cumulative urinary excretion after 43 days following the application accounted for 0.0082% (male) andfor 0.016% (female) of the applied dose. Presumed dose level: 50-75 mg/day.Estimated percentage absorbed Al: up to 0.012 % Al or 6 - 9 µg Al/day. Excretion via urine: 85% of total absorbed Al or 5.1 - 7.7 µg Al/day. Resulting absorbed Al: 0.9 - 1.3 µg Al/day or for 70 kg worker 0.013 - 0.019 µg Al/kg bw/day.After correcting this fraction for the aluminum notexcreted in urine (15% of the absorbed dose), this application was estimated to result in adermal bioavailability of about 0.012%. On the basis of these data, the authors estimated thatthe amount of aluminum absorbed from regular use would be 0.25 μg/d.Therefore, a one-time use of ACH applied to the skin is not a significant contribution to the body burden of aluminiumand there is no relevant dermal repeated dose toxicity to be expected.NOAEL: 0.71 - 1.07 mg Al/ kg bw/day. Mean value: 0.89 mg Al /kg bw/day.Calculated for Aluminium potassium bis sulphate:NOAEL: 6.79 - 10.24 mg Aluminium potassium bis sulphate/ kg bw/day.Mean value NOAEL: 8.52 mg Aluminium potassium bis sulphate/kg bw/day.
- Executive summary:
The cumulative urinary excretion after 43 days following the application
accounted for 0.0082% (male) and for 0.016% (female) of the applied dose.
Presumed dose level: 50-75 mg/day. Estimated percentage absorbed Al: up to 0.012 % Al or
6 - 9 µg Al/day. Excretion via urine: 85% of total absorbed Al or 5.1 - 7.7 µg Al/day.
Resulting absorbed Al: 0.9 - 1.3 µg Al/day or for 70 kg worker 0.013 - 0.019 µg Al/kg bw/day.
After correcting this fraction for the aluminum not excreted in urine (15% of the absorbed dose),
this application was estimated to result in a dermal bioavailability of about 0.012%.
On the basis of these data, the authors estimated that the amount of aluminum
absorbed from regular use would be 0.25 μg/d.
Therefore, a one-time use of ACH applied to the skin is not a significant contribution to the body burden of aluminium
and there is no relevant dermal repeated dose toxicity to be expected.
NOAEL: 0.71 - 1.07 mg Al/ kg bw/day. Mean value: 0.89 mg Al /kg bw/day.
Calculated for Aluminium potassium bis sulphate:
NOAEL: 6.79 - 10.24 mg Aluminium potassium bis sulphate/ kg bw/day.
Mean value NOAEL: 8.52 mg Aluminium potassium bis sulphate/kg bw/day.
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