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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 December 2009 - 8 January 2010
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD Guideline 423. GLP study.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
EC Number:
EC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
Cas Number:
Molecular formula:
Not applicable. Multiconstituent substance.
(2Z,7Z)-5-phenyl-2,7-bis(phenylimino)-2,7-dihydro-5λ⁵-phenazin-5-ylium (7Z)-N2,N3,5-triphenyl-7-(phenylimino)-5,7-dihydrophenazine-2,3-diamine N2,N3,5,7-tetraphenyl-5,7,12,14-tetrahydro-5,7,12,14-tetraazapentacene-2,3-diamine chloride
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): C.I. Solvent Black 5 (analogue CAS 11099-03-9).
- Lot/batch No.: 10137087
- Physical state: Blackish brown powder
- Storage condition of test material: Room temperature.
- Stability and uniformity were property has been confirmed.

Test animals

Crj: CD(SD)
Details on test animals or test system and environmental conditions:
- Source: Japan Charles River Co., Ltd.
- Age at study initiation: 9 weeks old
- Weight at study initiation: 231-233 g (group 1), 224-238 (group 2)
- Fasting period before study: Starved from p.m.5 of the day before dosing to 6 hours after dosing.
- Housing: Individually caged, Stainless steel 325x195x180 mm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 days

- Temperature (°C): 21.9-22.6ºC
- Humidity (%): 41-44.%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours per day (7:00 to 19:00) of artificial lighting

Administration / exposure

Route of administration:
oral: gavage
other: 0.5 w/v % methylcellulose solution
Details on oral exposure:
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

- Rationale for the selection of the starting dose: 2000 mg/kg dose was selected based on previous acute toxicity on the analogue Solven Yellow 3 (5, 50, 300 and 2000 mg/kg ) and Solvent Black 5 test (300 and 1000 mg/kg). In the first study, the LDLO was determined to be 1500 mg/kg. In the second study no toxicity was observed at 1000 mg/Kg.
2000 mg/kg bw (two steps)
No. of animals per sex per dose:
3 females / group
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: General conditions: daily during acclimation, pre-dose, 15 min, 30 min and every hour until 6 hours after administration, twice daily during the observation period, and once before necropsy. Body weight: Days -1, 0 (prior to administration), 1, 4, 7, 10, 13 and 14 (necropsy day)
- Necropsy of survivors performed: Yes (Day 14). Visual inspection of internal organs and tissues; organ weights. No histopathological inspection was considered necessary.

Results and discussion

Effect levels
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortality was observed.
Clinical signs:
other: Abnormal stool color (black) was observed in 1 of 6 animal after 3 hours from treatment, and in day 1 (6/6), day 2 (3/6) and day 3 (1/6). No other clinical sign was observed during the 14 day observation period.
Gross pathology:
No abnormal changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The discriminating dose was determined to be 2000 mg/kg bw in rats.
Executive summary:

An acute toxicity study was performed according to OECD Guideline 423 (GLP study). Six female rats were exposed to a single oral dose of 2000 mg/kg bw in two steps. After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted daily during the entire experiment. Body weights of the animals were periodically determined. After the 14-day observation period, the animals were euthanized and subjected to a necropsy and a detailed gross examination. All the animals survived the experiment. Abnormal stool color (black) was only observed at 3 hours and days 1, 2 and 3 after administration. During the 14-day experiment, body weight and body weight gain were found normal. Regarding the gross examinations, no lesions were found . The substance was classified as category 5 or less of the GHS regarding acute toxicity.