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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 16th June 2004 to 30th June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline 423. GLP study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, aluminum sodium salt, sulfurized
EC Number:
309-928-3
EC Name:
Silicic acid, aluminum sodium salt, sulfurized
Cas Number:
101357-30-6
Molecular formula:
|Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2
IUPAC Name:
Silicic acid, aluminum sodium salt, sulfurized
Details on test material:
- Name of test material : Ultramarine Blue, C.I. Pigment Blue 29

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 weeks
- Weight at study initiation: 183-190 g
- Housing: stainless-steel cages
- Water (e.g. ad libitum): free bottle of water intake tap water
- Acclimation period: 2 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23ºC
- Humidity (%): 55%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% sodium carboxymethylcellulose solution
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1time/day
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
No clinical signs
Body weight:
No effects
Gross pathology:
No autopsy findings for pathological damage.
Other findings:
Bluish feces in the 3 female rats of a group at 1st day after administration derived from the color of the test material.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The result was as follows: LD50 >2000 mg/kg bw

Executive summary:

The aim of the test was to study the single dose oral toxicity of the test material according to OECD Test Guideline 423.

The test material was studied in 6 female rats (2 groups with 3 female rats per group) in a single dose oral toxicity test at 2000 mg/kg bw. On observation for general signs, only bluish feces, derived from the color of the test material, were noted. The result was as follows: LD50 >2000 mg/kg bw