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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 April, 1995 - 26 April, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
422-150-1
EC Name:
-
Molecular formula:
Hill formula: Mg4.3 Al2(OH)12.6 (CO3)0-0.75 (ClO4)0.5-2.0 . (0-5)H2O CAS formula: Mg4.3 Al2(OH)12.6 (CO3)0-0.75 (ClO4)0.5-2.0 . (0-5)H2O
IUPAC Name:
Aluminium-magnesium-carbonate-hydroxide-perchlorate-hydrate
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: white powder
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
other: Wistar Crl: (WI) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: males: 288 - 337 g; females: 206 - 229 g
- Housing: Individually housed in labelled polycarbonate cages.
- Diet: Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Details on dermal exposure:
One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.

The formulation was applied in an area of approx. 25 cm^2 (5x5 cm) for males and 18 cm^2 (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage, with drops of petrolatum.

Frequency: Single dosage, on Day 1.

Washing: Following application, dressings were removed and the skin cleaned of residual test substance using a tissue moistened with tap water.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.

Dose volume: 10 mL/kg

DOSAGE PREPARATION: The formulation (w/w) was prepared immediately prior to dosing. Adjustment was made for specific gravity of vehicle (0.92). Homogeneity was accomplished to a visually acceptable level.

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: All animals surviving to the end of the observation period (day 15) were sacrificed by oxygen/carbon dioxide asphyxiation. All animals assigned to the study were subjected to necropsy and descriptions of all macroscopic abnormalities recorded.
- Other examinations performed: none.
Statistics:
None.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died.
Clinical signs:
No clinical signs were observed.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not toxicologically significant.
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.
Other findings:
Erythema, scales and scabs were seen in the treated skin-area among four females during the observation period.

Any other information on results incl. tables

One female had lost the patch within 24 hours. The results from this animal were excluded from interpretation. 

This did not affect study integrity.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified.
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
In an acute dermal toxicity study with rats, performed according to OECD 402 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.
Executive summary:

Alcamizer 5 was tested in an acute dermal toxicity study with male and female rats, performed according to OECD 402 test guideline and GLP principles.

No mortality occurred. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not toxicologically significant. No abnormalities were found at macroscopic post mortem examination of the animals. Erythema, scales and scabs were seen in the treated skin-area among four females during the

observation period. Based on the results, an LD50 >2000 mg/kg bw was determined. Alcamizer 5 does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).