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Administrative data

Description of key information

Based on the available oral and dermal acute toxicity studies, the Solvent Black 46 does not meet the criteria for classification.

No inhalation acute toxicity study was performed since not exposure is expected during the manufacturing process or the use in the final product.

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:
from 2011-12-06 to 2011-12-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: elevage JANVIER (53940 Le Genest St Isle - FRANCE)
- Age at study initiation:8 weeks old
- Weight at study initiation: between 181 g and 199 g
- Fasting period before study: Drinking water (tap water from public distribution system) and foodstuff (M20, SDS) were supplied freely. Food was removed at D-1 and then redistributed 4 hours after the test item administration
- Housing: Animal were housed by group of 3 in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Cage was installated in conventional air conditioned animal husbandry
- Diet (e.g. ad libitum): Ad libitum.
- Water (e.g. ad libitum):Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h dark/12h light
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: adapted for each animals
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Olive oil was chosen among various vehicules because it does not induce pain. It has been chosen since it allowed to prepare a homogenous mixture, under stirring, usable for oral administration


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on previous examination of similar molecules, the dose of 2000 mg/kg was chosen.
Doses:
The 2 treated groups were dosed at 2000 mg/kg body weight
No. of animals per sex per dose:
3 females/dose/step:
STEP 1: 3 females at 2000 mg/kg body weight (N° Rf 9009, 9010 and 9011)
STEP 2: 3 females at 2000 mg/kg body weight (N° Rf 9048, 9049 and 9050)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations (spontaneous activity, preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance) and weighing on days D0 (before administration), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examinations at the end of the study (after anaesthesia) with the examination of organs likely to be modified in cases of acute toxicity (i.e. oesophagus, stomach, the entire digestif tract, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, treatment area, adrenals, pancreas).
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study
Clinical signs:
At T0 + 1 hour: STEP 1: blue faeces in all the treated animals / STEP 2: Rf 9049 and 9050 = blue faeces. Rf 9048 = decrease in spontaneous activity.

At T0 + 3 and 4 hours: Blue faeces in all the treated animals in both step.

D1 to D10: STEP 1: blue faeces in all the treated animals / STEP 2: blue faeces in all the treated animals and Rf9049 = decrease in spontaneous activity from D8 to D10.

D11 to D12: STEP 1: blue faeces in all the treated animals / STEP 2: nothing to report

D13 to D14: Nothing to report in all the treated animals in both step.
Body weight:
A decrease in body weight of two animals (Rf 9048 and 9049 - STEP 2) was noted on day 7: between -9% and -19% respectively, compared to day 0.
Gross pathology:
The macroscopical examination of the animals at the end of the study revealed a white thickening of the forestomach in all the treated animals of the STEP 2.
No other observations or abnormalities were to report.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Sepisol Black 46 is higher than 2000 mg/kg body weight by oral route in the rat.
In accordance with the OECD guideline N° 423, the LD50 cut-off of the test item may be considered to be higher than 2000 mg/kg body weight by oral route in the rat.
According to the classification, packaging and labelling of dangerous substances and preparations in accordance with the EEC directives 67/548, 2011/59 and 99/45, the test item Sovent Black 46 must not be classified. No symbol or risk phrase is required.

In accordance with the regulation EC N° 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item Solvent Black 46 was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the OECD guideline N° 423 dated December 17th, 2001 and the test method B.1tris of the Council regulation N°440/2008.

No mortality occured during the study.

From the first day of the test, decrease in spontaneous activity (3/6) and blue faeces (6/6) were observed. The animals recovered a normal spontaneous activity on day 1 (2/3) and on day 10 (1/3), and recovered normal faeces on day 11 (3/6) and on day 13 (3/6).

A decrease in body weight of two animals (2/6) was noted on day 7: between -9% and -19% compared to day 0.

The macroscopical examination of the animals at the end of the study revealed a white thickening of the forestomach (3/6).

In conclusion, the LD50 of the test item Sepisol Black 46 is higher than 2000 mg/kg body weight by oral route in the rat.

In accordance with the OECD guideline N° 423, the LD50 cut-off of the test item may be considered to be higher than 2000 mg/kg body weight by oral route in the rat.

According to the classification, packaging and labelling of dangerous substances and preparations in accordance with the EEC directives 67/548, 2011/59 and 99/45, the test item Solvent Black 46 must not be classified. No symbol or risk phrase is required.

In accordance with the regulation EC N° 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Good quality of the database

Acute toxicity: via inhalation route

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:
experimental study
Adequacy of study:
key study
Study period:
From 2011-12-06 to 2011-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - FRANCE)
- Age at study initiation: MALE: 8 weeks old. FEMALE: 9 weeks old
- Weight at study initiation: MALE : from 265 g to 290 g. FEMALE: from 210 g to 242 g
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5, in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): ad libitum (foodstuff: M20-SDS)
- Water (e.g. ad libitum): ad libitum (tap water from public distribution system)
- Acclimation period: of at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 dark/12 light
Type of coverage:
occlusive
Vehicle:
paraffin oil
Details on dermal exposure:
TEST SITE
- Area of exposure:dorsal area of the trunk
- % coverage: at least 10% of the body surface cleared for the application of the test item
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with liquid paraffin
- Time after start of exposure: After 24 hours exposure period

TEST MATERIAL
- Concentration (if solution): 2000 mg/L
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICULE
Duration of exposure:
Exposure period of 24 hours
Doses:
Group 1: 2000 mg/kg
Group 2: 2000 mg/kg
No. of animals per sex per dose:
Group 1: 5 male rats
Group 2: 5 female rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily examination (spontaneous activity, preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance). Weighing on days D0 (before administration of th test item), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examinations at the end of the study (after anaesthesia) with the examination of organs likely to be modified in cases of acute toxicity (oesophagus, stomach, the entire digestiv tract, spleen, liver, thymus, trachea, lungs, heart, kidneyx, urinary bladder, testicules, skin of the treatment area, adrenals, pancreas).
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study
Clinical signs:
No clinical sign was observed. A slight black coloration of the treatment site was noted in all animals on D1.
Body weight:
The body weight evolution of the animals remained normal throughout the study by comparison with the control animals standing in the same environment.
Gross pathology:
No gross pathology was observed.

Current control study: The study identified TAD-PH-11/0623 was performed to assess the behaviour of the strain of rat used at this laboratory in its environment and to give additional historical data. The study was performed from 25 October 2011 to 08 November 2011.

the method was designed to meet the requirements of the following: OECED guideline for the testing of chemicals N°402 dated February 24thn, 1987 and the method B3 of the Council regulation N°440/2008.

Test item: Liquid paraffin

METHODS:

Ten aminals, five males and five females, received by topical administration, an effective dose of 10 ml/kg body weight of the control item liquid paraffin, under porous gauze dressing, during 24 hours.

RESULTS:

Clinical examinations: Nothing to report. Animal normal (10/10)

Bodyweight evolution: Normal throught the study

Necropsy: No treatment related changes were observed.

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Solvent Black 46 is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item Solvent Black 46 must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item Solvent Black 46 was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3. of the Council regulation n°440/2008 of 30 May 2008.

No mortality occured during the study.

No systemic clinical sign related to the administration of the test item was observed. A slight black coloration of the treatment site was noted in all animals on day 1.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item Solvent Black 46 is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.

According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item Solvent Black 46 must not be classified. No symbol or risk phrase is required.

In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Study GLP compliant with a Klimish score of 1.

Additional information

Both oral and dermal acute toxicity studies were performed under GLP conditions and have a Klimish score of 1. In both studies, no adverse effects were observed at the highest tested dose of 2000 mg/kg bw. So according to the criteria of classification the Solvent Black 46 must not be classified.

No inhalation acute toxicity study was performed since no exposure is expected. Exposure of human via inhalation route of consumer is unlikely taking into account that there is no vapour pressure. Exposure is likely only during production where respiratory protection and local ventilation are used to avoid any exposure of the workers to particules.

As being a solid, the dye does not meet either the criteria for aspiration hazard.

Justification for selection of acute toxicity – oral endpoint

Only one study available

Justification for selection of acute toxicity – inhalation endpoint

No exposure is expected

Justification for selection of acute toxicity – dermal endpoint

Only one study available

Justification for classification or non-classification

Based on the available data, the substance is not classified.