Reaction mass ofDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN1}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-) andDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-)

Endpoint summary

Description of key information

The acute LD50 of the substance is greater than 2000 mg/kg bw.

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:

Study start date - 11 December 1979; Study completion date - 29 January 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Code number of the test material used in the study report: 20037/B
- Physical appearance: solid

Species:

rat

Strain:

other: Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house
- Age at study initiation: 7-8 weeks old
- Fasting period before study: Overnight
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Diet: NAFAG, Gossau SG rat food ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION: FAT 20037/B was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

4000, 5000, 6000 and 8000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and weighing Days 1, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen at the dose levels of 4000, 5000 and 6000 mg/kg bw. However, 2 out 5 females died at the dose level of 8000 mg/kg bw.

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs associated with all dose levels. In addition to the above mentioned symptoms, sedation was also observed at the dose level of 8000 mg/kg bw. All the surviving

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in rats was determined to be greater than 8000 mg/kg bw.

Executive summary:

The acute oral LD50 of the test item was determined in a study conducted according to the methodology that is equivalent to the OECD Guideline 401. Groups of 5 males and 5 females each, were administered the test item diluted in distilled water by gavage. The doses administered were 4000, 5000, 6000 and 8000 mg/kg bw. Clinical signs, mortality check and body weight were recorded during an observation period of 14 days. Animals were submitted to a necropsy whenever they died, survivors at the end of the observation period. No mortality was seen at the dose levels of 4000, 5000 and 6000 mg/kg bw. However, 2 out 5 females died at the dose level of 8000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs associated with all dose levels. In addition to the above mentioned symptoms, sedation was also observed at the dose level of 8000 mg/kg bw. All the surviving animals recovered within 8 days. Further, the test item administration did not affect body weight gains at any dose levels. No substance related gross organ changes were seen with any of the treated animals. Based on the above findings, the acute oral LD50 in rats was determined to be greater than 8000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

8 000 mg/kg bw

Quality of whole database:

Good quality database, as the study used in this assessment is conducted following sound scientific principles and well documented.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

In an acute oral toxicity study, the acute oral LD50 of the test item was determined according to a method equivalent to the OECD Guideline 401. Groups of 5 males and 5 females each, were administered the test item diluted in distilled water by gavage. The doses administered were 4000, 5000, 6000 and 8000 mg/kg bw. Clinical signs, mortality check and body weight were recorded during an observation period of 14 days. Animals were submitted to a necropsy whenever they died, survivors at the end of the observation period. No mortality was seen at the dose levels of 4000, 5000 and 6000 mg/kg bw. However, 2 out 5 females died at the dose level of 8000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs associated with all dose levels. In addition to the above mentioned symptoms, sedation was also observed at the dose level of 8000 mg/kg bw. All the surviving animals recovered within 8 days. Further, the test item administration did not affect body weight gains at any dose levels. No substance related gross organ changes were seen with any of the treated animals. Hence, based on the above findings, the acute oral LD50 in rats was determined to be greater than 8000 mg/kg bw.

In another acute oral toxicity study, the acute oral LD50 of the test item was determined according to the methodology that is equivalent to the OECD Guideline 401. Groups of 5 males and 5 females each, were administered the test item diluted in distilled water by gavage. The doses administered were 1000, 3000, 10000 and 15000 mg/kg bw. Clinical signs, mortality check and body weight were recorded during an observation period of 15 days. No mortality was recorded in animals treated at 1000, 3000 and 10000 mg/kg bw. However, 5 out of 10 animals died at the dose level of 15000 mg/kg bw. Hyperreflexia lasting about 60 minutes was recorded with all the dose levels. At the dose level of 3000 mg/kg bw, in addition to hyperreflexia, hypoventilation and reduction in spontaneous motility were also observed. These symptoms lasted till Day 4. At the dose level of 10000 mg/kg bw, dyspnoea, ataxia, ventricumbency, muscular hypotonia, inhibition of the response to pain (pinching) and diarrhea were also observed. Further, the test item administration did not affect body weight gains at any dose levels. Hence, based on the above findings, the acute oral LD50 in rats was determined to be 15000 mg/kg bw.

Acute toxicity: inhalation

Currently no study to assess the acute inhalation toxicity potential of Acid Black 107 is available. The melting point of test substance was found to greater than 300 °C indicating low vapour pressure. Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the chemical is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is considered to be unlikely. Further, the chemical is found to have water solubility of 55 g/L, hence, in the case of dust of the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50: > 8000 mg/kg bw), hence, it does not need to be classified STOT SE and low toxicity is expected for this chemical via the inhalation route. Taking above arguments into account, low toxicity potential is expected on acute exposure of Acid Black 107 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.

Acute toxicity: dermal

Currently no study to assess the acute dermal toxicity potential of Acid Black 107 is available. The molecular weight of Acid Black 107 is greater than 700 g/mol, indicating it being too large for dermal absorption. It has water solubility of 55 g/L and n-octanol/water partition coefficient (log P) of 0.357, indicating it being too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance will be low. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50: > 8000 mg/kg bw), hence, it does not need to be classified as STOT SE. Similarly, absence of systemic toxicity in skin irritation and sensitization studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Taking above arguments into consideration, low toxicity is expected on acute dermal exposure of Acid Black 107 and testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

Based on the available data as discussed above, the substance does not warrant classification according to CLP (Regulation 1272/2008) criteria.