Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03-18 to 2008-06-02
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
first addendum
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %; UVCB substance)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc., TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, 9-10 weeks old
- Weight at study initiation: 184-197 g
- Housing: Group caging (3 animals/cage)
- Diet (e.g. ad libitum): Animals received ssniff® R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Route of administration:
oral: gavage
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, body weights were measured on day 0 (beginning of the study), on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
F 46 Black did not cause mortality at 2000 mg/kg bw dose levels in female CRL: (WI) BR rats.
Clinical signs:
2000 mg/kg bw - Treatment group 1: no clinical signs were noted for these animals (3/3).
2000 mg/kg bw - Treatment group 2: all the three animals were symptom-free on the day of treatment and during the 14-day observation period
Body weight:
2000 mg/kg bw - Treatment group 1: The body weight development of each animal was normal throughout the two weeks observation period, similar to untreated female animals of the same age and strain
2000 mg/kg bw - Treatment group 2: There was no test item influence on the body weight and body weight gain of these animals
Gross pathology:
2000 mg/kg bw – Treatment group 1 and Treatment group 2:
No macroscopic alterations related to any toxic effect of the test item were found.
Gross pathology examinations revealed pulmonary alterations due to the method of anaesthesia and exsanguination, which are also observable in untreated animals after anaesthesia. Pale raised areas (1/3 in treatment group 1; 1/3 in treatment group 2) reddish mottled colour (1/3 in treatment group 1) and pinprick sized haemorrhages (2/3 in treatment group 2) were observed in the lungs at the necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, a single oral administration of the test item F 46 Black did not reveal any toxic effects in female CRL:(WI)BR rats up to the limit concentration of 2000 mg/kg bw. The LD0 was 2000 mg/kg bw and the LD50 > 2000 mg/kg bw.
Executive summary:

Based on a study according to EU method B.1 tris and OECD 423, a single oral administration of the test item F 46 Black up to the limit concentration did not reveal any toxic effects in female CRL:(WI)BR rats. The LD0 was 2000 mg/kg bw and the LD50 > 2000 mg/kg bw.