Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01.08.2017 - 16.08.2017
Reliability:
1 (reliable without restriction)

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)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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:
Substance name: Solvent Red 19T
Other name: 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-Ntridecylnaphthalen-2-amine
CAS number: 57712-94-4
EC Number: 260-913-7
Batch/Lot Number: TE 2139
Description: Dark red viscous liquid
Purity: 95-100%
Expiry date: 07 July 2018
Storage conditions: Room temperature (15-25°C, ≤70 RH%)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
Two groups of 3 Female Crl:WI Wistar rats were treated.
- Age at study initiation: 9 weeks (young healthy adults)
- Weight at study initiation: 214-248 g
- Acclimatisation period 12-13 days
- A single oral treatment was given following overnight food withdrawal. Food was made available agian 3 hours after the treatment.
- Housing: 3 animals of one sex in one cage (polypropylene/polycarbonate)
- Diet: ssniff standard 'complete diet for rats and mice' ad libitum
- Water: Drinking tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 - 24.6 °C
- Relative humidity (%): 31 - 68 %
- Air changes (per hr): 15-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark

STUDY TIME SCHEDULE
Animal supply: 20.07.2017
Experimental part of study: 01.08.2017 - 16.18.2017

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Details on oral exposure:
VEHICLE Lot/batch no: BCBS8295V (Sigma Aldrich)
The test item was formulated at a concentration of 200mg/mL in the vehicle, prepared on the day of administration. The formulation was ultrasonicated, thereafter it was magnetically stirred continuously during dose adminstration procedures.

- Rationale for the selection of the starting dose:
The test procedure starting dose of 2000 mg/kg bw was selected. (to be that which is most likely to produce mortality in some of the dosed animals in the lack of any preliminary toxicological information)
The test substance at this dose level was administered to one groups of three females. No mortality was observed therefore a further confirmatory group of 3 animals were treated at the dose level of 2000mg/kg bw. No death of animals was observed and therefore the testing was finished.

On the night before treatment, animals were fasted. Food was withheld, but not water. A single oral gavage administration was given the following morning. Food was returned 3 hours after the treatment.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Group 1: 3 females
Group 2: 3 females
Control animals:
no
Details on study design:
--Post exposure observation period:
A 14 day observation period followed.
- Frequency of observations and weighing:
- Body weight: Before application (Day -1), on the day of treatment (Day 0), Day 7 and Day 14 (at necropsy).
- Mortality: Daily
- Clinical observations were peformed on all animals at 30 mins, 1, 2, 3, 4 and 6 hours after dosing, and then daily for 14 days.
Observations included changes in the skin and fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour of animals, In additional observations were made for tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy/Pathological examination: All test animals survived to the end of the study and were sacrificed by exsanguination under pentobarbital anaesthesia. After examination of the external appearance, the cranial, thoracic and abdominal cavity opened and the organs and tissues observed. Macroscopic abnormalities were recorded if they were present.
- Clinical signs, body weight, body weight gain and gross macroscopic data were tabulated.

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: Solvent Red 19T did not cause mortality at a dose level of 2000mg/kg bw.
Clinical signs:
Reddish coloured faeces were observed in all animals up to Day 3, which was related to the test item. From Day 4, all animals were symptom free during the 14 day observation period.
Body weight:
Body weights were within the range commonly recorded for this strain and age, there were no treatment related body weight changes.
Gross pathology:
There was no evidence of macroscopic changes at the tested dose.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (EU criteria)
Conclusions:
Under the conditions of this study, the acute Oral LD50 value of Solvent Red 19T was found to be above 2000mg/kg bw in female Crl:WI Wistar rats.
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 (Sesame oil), given orally via gavage to two groups of three female Wistar rats.

Initially, three females (Group 1) were treated at a dose of 2000mg/kg of body weight. As no mortality was observed a confirmatory group was treated at the same dose level.

The test substance administered at the dose of 2000 mg/kg caused no deaths in either group. There were no treatment related body weight changes, no evidence of pathologic macroscopic changes. The only clinical observation was reddish coloured faeces up to day 3. From Day 4 all animals were symptom free.

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