Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02.-03.1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The study report contains the limited information on the test conditions because the study has been performed in 1991 . However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Direct Blue 78- Physical state: solid, powder- Analytical purity: 95% (w/w)- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 10% (w/w)- Lot/batch No.: 7013/207- Expiration date of the lot/batch: unlisted- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMAL- Number of animals: 5- Weight at study initiation: 264-294 g- Housing: 1 animal per cage

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE - Area of exposure: 4x6 cm, depilated skin - Type of wrap if used: mull, aluminium fall, plaster bandage REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 24h TEST MATERIAL - Amount(s) applied: 5g/kg - For solids, paste formed: yes (substance+ 1,5 ml water)
Duration of exposure:
24h
Doses:
5.0 g/kg
No. of animals per sex per dose:
5 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: after 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical observation of animals was practised every day,

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Mortality:
no mortality during test
Clinical signs:
No clinilac signs after aplication
Body weight:
Normal weight gain
Gross pathology:
After 14 days all animals were sacrificed. No macroscipical findings were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not absorbed in a toxic quantity.
Executive summary:

The substance is not absorbed in a toxic quantity.