Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17.9.2012 -2.10.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Solvent Red 19E
- Physical state: dark viscous liquid/borderline waxy solid
- Analytical purity: 90% (w/w)
- Impurities (identity and concentrations): Solvent Red24 (CAS 85-83-6) 2% (w/w)
- Lot/batch No.: S2409
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: in well closed original container at the temperature bellow 25°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 147-163 g
- Fasting period before study: 20 h. Feed was given to the animals 3 hours after application of the test substance.
- Housing: Animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): standard pelleted diet ad libitum
- Water (e.g. ad libitum): Drinking tap water ad libitum
- Acclimation period: Min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Relative humidity (%): 30-70 %
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark

STUDY TIME SCHEDULE
Animal supply: 12.09.2012
Experimental part of study: 17.09.2012 - 02.10.2012

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Lot/batch no. (if required): 5211201
- Purity: Pharmaceutical quality

MAXIMUM DOSE VOLUME APPLIED: The single volume of administered suspension was 1mL/100 g of animal body weight.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The test procedure starting dose of 2000 mg/kg was selected. The test substance at this dose level was administered sequentially to two groups of three females (application with time distance 24 hours). No death of animals was observed and therefore the testing was finished.
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
3 females (step 1), 3 females (step 2)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Body weight: Before application, 8th day and 15th day before euthanasia of animals. Average body weight in a group was calculated from individual body weights. Body weight increments were calculated from body weight at the start of the study, the first week and at the end of the study.
- Mortality: Daily
- Clinical examination: After application, the animals were observed individually. The first day observations were made twice, 30 minutes and three hours after application. The second day, observations were made twice, in the morning and the afternoon, and daily thereafter for 14 days. Observations included changes in the skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system. The results of observations were recorded.
- Pathological examination: All test animals survived to the end of the study were sacrificed on the 15th day by injection of veterinary preparation T61 (1 mL i.v.) and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. Al gross macroscopic changes of organs were recorded.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
The clinical signs of intoxication (piloerection and gibbous posture) were detected 30 minutes after the 1st day of application in all six animals. Detected clinical changes did not influence the classification of the test substance.
Body weight:
Weight increments were adequate to species, sex and age of animals in experiment.
Gross pathology:
No pathologic macroscopic changes were diagnosed during pathological examination.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (EU criteria)
Conclusions:
The LD50 of the test material is > 2000 mg/kg of body weight.
Executive summary:

The acute toxic effects of the test substance were assessed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, and OECD Test Guideline 423.

The test substance was administered in a single dose as solution in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats.

The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the starting dose of 2000 mg/kg of body weight and group No. 2 - second step using the same dose.

The test substance administered at the dose of 2000 mg/kg caused no deaths. The clinical signs of intoxication (piloerection and gibbous posture) were detected 30 minutes after the first day of application in all six animals. No pathologic macroscopic changes were diagnosed during pathological examination.

The LD50 of the test material is > 2000 mg/kg of body weight.