Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18/05/2017-14/06/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot No.of test material: 78-242-15
- Expiration date of the lot: 01/02/2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 wks
- Weight at study initiation: step 1, animals N.1-3: 148-153 g; step 2, animals N. 4-6: 176-179 g
- Housing: full barrier in an air-conditioned room
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking watre, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 55+/- 10%
- Air changes (per hr): 10x7 hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ mL
- Amount of vehicle (if gavage): 10 mL/ kg
Doses:
The startin dose was selected to be 2000 mg/kg bw. No compound-related mortality was recorded for any animal of step 1 or 2. Basd on these results and according to the acute toxic class method regime no further tasting was required.
No. of animals per sex per dose:
Two groups, each of three female WISTAR Crl: WI(Han) rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: The animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
The test item showed no mortality but acute oral toxicity characteristics after a single dose administration.
Clinical signs:
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/ kg bw were reduced spontaneous activity, huntched posture, prone position, sunken flanks, piloerection and half eyelid closure. All symptoms recovered within the first day post-dose.
Body weight:
Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.
Gross pathology:
At necropsy, no macroscopic findings were observed in any animal of any step.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the conditions of the present study, a single oral application of the test item YELLOW 2747 to rats at a dose of 2000 mg/ kg bw was associated with signs of toxicity but no mortality.
The median lethal dose of YELLOW 2747 after a single oral administration to femal rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/ kg bw
According to Annex I of regulation (EC) 1272/2008 the test item YELLOW 2747 has no obligatory labelling requirement for toxicity and is not classified.
According to GHS the test item YELLOW 2747 has obligatory labelling crequirement for toxicity and is classified into Category 5.