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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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Acute (Mouse and Rat) and Short-term (Rat) Toxicity Studies on Black PN
Author:
I.F. Gaunt, Madge Farmer, P. Grasso, S.D. Gangolli
Year:
1967
Bibliographic source:
Food and Cosmetics Toxicology Volume 5, 1967, Pages 171-177

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Oral dosages of compound were administered by oral intubation to the mouse. Animals were observed usually for 14 days during which time the development of toxic signs was followed and time of death recorded.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Brilliant Black PN- Molecular formula (if other than submission substance): C28H17N5Na4O14S4- Molecular weight (if other than submission substance):867.66716 g\mol- Substance type: Organic- Physical state: Solid-Purity:83.6%

Test animals

Species:
mouse
Strain:
other: ICI Alderley Park Strain 1 SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: No data available- Age at study initiation: No data available- Weight at study initiation: No data available- Fasting period before study: 18 hr prior to dosing- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
No data available
Doses:
no data
No. of animals per sex per dose:
10 mice/sex
Control animals:
yes
Details on study design:
no data available
Statistics:
LD50 values with 95 % confidence limits were calculated according to Litchfield & Wllcoxon (1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: with 95 %confidence limits
Mortality:
No mortality observed
Clinical signs:
no toxic signs observed
Body weight:
No data available
Gross pathology:
No data available
Other findings:
Orally, a substantial amount of coloured material was excreted in the faeces.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
In acute toxicity study by oral route the LD50 value for the Brilliant Black PN was found to be >2000 mg/kg for mice.
Executive summary:

Acute toxicity test was performed on mice at concentration of 2000 mg/kg and observed for 14 days.10 mice/sex were used. The LD50values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study.

 

Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice.