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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1989 - March 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test:The sample was applied at a dose of 5000 mg / kg A paste was prepared from sample by adding water and aplied on depilated rat skin of 4 × 6 cm area.- Short description of test conditions: 5 Wistar rats , males, individually caged After 24 h the plaster bandage was removed and followed by observation for 14 days.- Parameters analysed / observed: behaviour, macroscopic examination of organs (probably weight, but not specified)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate
EC Number:
274-427-8
EC Name:
Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate
Cas Number:
70210-31-0
Molecular formula:
C43H30N8O14S4.4Na
IUPAC Name:
tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate
impurity 1
Reference substance name:
Colorless components
IUPAC Name:
Colorless components
Test material form:
solid: particulate/powder
Details on test material:
Other name: Saturnová nám. modř LFG konc. ; sample No. 196/89
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Saturnová nám. modř LFG konc. ; VCHZ Synthesia Semtín, sample No. 196/89 - Expiration date of the lot/batch: not specifiedPurity: 40 - 50% of the tested substance; 50 - 55% (NaCl, Na2SO4)STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: not specified- Solubility and stability of the test substance in the solvent/vehicle: 20 g/L of waterTREATMENT OF TEST MATERIAL PRIOR TO TESTING- Final dilution of a dissolved solid, stock liquid or gel: a paste was prepared from sample by adding water

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: not specified- Age at study initiation: not specified- Weight at study initiation: 251 – 256 g - Fasting period before study: not specified- Housing: individually in cage - Diet (e.g. ad libitum): not specified- Water (e.g. ad libitum): not specified- Acclimation period: not specified ENVIRONMENTAL CONDITIONSnot specified (laboratory conditions)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE - Area of exposure: 4 × 6 cm REMOVAL OF TEST SUBSTANCE - Washing (if done): not specified - Time after start of exposure: 24 h TEST MATERIAL - Amount(s) applied (volume or weight with unit): 5000 mg/ kg - For solids, paste formed: yes, sample mixed with water
Duration of exposure:
24 h
Doses:
5000 mg/ kg
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations: before exposure and after observation period before autopsy - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, macroscopic examination of organs

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat. (total fraction)
Mortality:
no
Clinical signs:
no clinical signs of intoxication
Gross pathology:
No pathomorphological changes in the macroscopic examination of organs.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50> 5000 mg/kg
Executive summary:

The tested substance Direct Blue 85 (Saturnová nám. modř LFG konc.) is not absorbed in toxic amount, therefore it is not classified as acute toxic by dermal route.

LD50> 5000 mg/kg