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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability is rated 1 because the study followed the standard guideline of reference (OECD 423), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
IUPAC Name:
Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
Details on test material:
- Name of test material : Sepisol Fast Violet 2B
- Physical state/ appearance: dark violet powder
- Lot/batch No.: 423393
- Storage condition of test material: ambient temperature and in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: élevage Janvier, Le Genest-St-Isle, France
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: At d1, mean (for group 1 and group 2 ): 220.4 gram +/- 7.8
- Fasting period before study: deprived of food overnight prior to dosing (and until 3 to 4 hours following administration)
- Housing: polypropylen cage. Maximum 3 animals per cage
- Diet : ad libitum.
- Water: ad libitum.
- Acclimation period: 5 days at least before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: adapted for each animal
- Amount of vehicle : 5 mL/kg
- Justification for choice of vehicle: corn oil was chosen among various vehicules because it does not induce pain. Following several preliminary
assays, the aqueous-based vehicles (pure water, HCMC) were disregarded and the non-polar vehicle (corn oil commonly used for oral toxicity assay ) has been chosen since it allowed to prepare a homogenous mixture usable for oral adiministration.
- Lot/batch no. : 07030169/C

Doses:
2000 mg/kg
No. of animals per sex per dose:
3 rats for both steps (6 in total)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: regularly following administration (30 min, 1h, 2h, 3h and 4 h) and at least once a day during the 14 days
- Frequency of weighing: d-1, d1 T0, d4, d8, d15
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
first dose of 2000 mg/kg with 3 animals
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
At the 2000 mg/Kg dose: no deaths were observed.
Clinical signs:
At the 2000 mg/kg dose, significant symptoms occured: important piloerection, reduced motor activity, coloured feces during the first 4 hours
Body weight:
At the 2000 mg/kg: the mean body weight observation has not shown any sign associated with the test material

Any other information on results incl. tables

Clinical observations

At the 2000 mg/kg dose:

 Time of observation  Comments  Time of observation  Comments
 D1 (following administration)  Important piloerection and reduced motor activity for all animals  D6  -
 D1 T30' Similar to D1 (following administration) -dark/blue feces were observed for 4 of them  D7 -
 D1 T1h Similar to D1 T30' and dark/blue- feces observed for all of them  D8  -
 D1 T2h Similar to D1 T1h  D9 -
 D1 T3h Similar to D1 T1h  D10
 D1 T4h Similar to D1 T1h  D11  -
 D2 Similar to D1 T30' for 2 females - and important piloerection for 3 others D12  -
 D3 Important piloerection for all of them D13  -
 D4 Important piloerection for 2 females. D14   -
 D5 -  D15  -

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the CLP regulation, the test material Sepisol Fast Violet 2B has not been classified as acute toxicity with a
LD 50 determined to be above the threshold of 2000 mg/kg bw.
Executive summary:

The aim of this study was to assess qualitatively and quantitatively the toxic effects and the delay of the appearance after single oral administration of a pre-defined dose of 2000 mg/kg body weight, of test element named SEPISOL FAST VIOLET 2B suspended in corn oil, in 6 females rats, using a stepwise procedure. The study has been performed by using the OECD guideline 423.

The animals were daily observed for at least 14 days after administration and the clinical signs and signs of toxicity were noted.

A preliminary test was performed with a 2000 mg/kg dose after which no animals dies.

The results of the assay showed that 6 animals did not die with the 2000 mg/kg dose level.

Significant symptoms occured: important piloerection, reduced motor activity with diarrhoea and coloroued feces during the first four days.

This test provided results allowing the test element not to be classified according to the Classification and Labeling of Products regulation (CLP EC 1272/2008).

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