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Administrative data

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw, EU Method B.1 tris, OECD 423, GLP compliant

Read across to an analogue substance for Acute dermal toxicity: LD50 > 2000 mg/kg bw, EU Method B.3, OECD 402, GLP compliant

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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)
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
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
GLP study according to current OECD/EU guidelines, reliabilty of 1.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Interpretation of results:
GHS criteria not met
Conclusions:
A read across approach to an analogue substance was used to predict the Dermal LD50 of Solvent Red 19T. The dermal LD50 is predicted to be >2000mg/kg. Solvent Red 19T does not therefore need to be classified according to EU CLP criteria with regards to Acute Dermal Toxicity.
Executive summary:

A read across approach was used to predict the Acute Dermal Toxicity of Solvent Red 19T

( 1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-N-tridecylnaphthalen-2-amine).

Acute Oral data for an analogue substance, with the same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group showed the same oral toxicity. Based on the structural and other chemical similarities, it is predicted that the 2 subtances will also have similar dermal toxicity properties. The Acute dermal toxicity of the analogue substance was >2000mg/kg. It is predicted that Solvent Red 19T will also have an acute dermal toxicity >2000mg/kg and does not need to be classified with respect to acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Read across to: GLP study according to current OECD/EU guidelines, reliabilty of 1.

Additional information

ORAL:

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.

INHALATION

In accordance with column 2 of REACH Annex VIII, the Acute toxicity inhalation study (required in section 8.5.2) does not need to be conducted. The dermal route is provided to the oral route as more appropriate than inhalation route (with respect to the low vapour pressure and the use of the substance).

DERMAL:

A read across approach was used to predict the Acute Dermal Toxicity of Solvent Red 19T

( 1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-N-tridecylnaphthalen-2-amine).

Acute Oral data for an analogue substance, with the same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group showed the same oral toxicity. Based on the structural and other chemical similarities, it is predicted that the 2 subtances will also have similar dermal toxicity properties. The Acute dermal toxicity of the analogue substance was >2000mg/kg. It is predicted that Solvent Red 19T will also have an acute dermal toxicity >2000mg/kg and does not need to be classified with respect to acute dermal toxicity.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity.