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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database.

Data source

Reference
Reference Type:
other: authoritative database
Title:
Acute oral toxicity study of test chemical was performed in rats.
Author:
Ministry of Health, Labour and Welfare, Ministry of the Environment and National Institute of Technology and Evaluation.
Year:
2010
Bibliographic source:
J-CHECK Japan Chemicals Collaborative Knowledge database

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
EC Number:
229-245-3
EC Name:
3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
Cas Number:
6448-95-9
Molecular formula:
C24H18N4O4
IUPAC Name:
3-hydroxy-4-[(2-methyl-5-nitrophenyl)diazenyl]-N-phenyl-2-naphthamide
Details on test material:
- IUPAC name: 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide- Name of test material (as cited in study report): C.I. Pigment Red 22 - Molecular formula (if other than submission substance):C24H18N4O4- Molecular weight (if other than submission substance):426.43 g/mole- Smiles: O=C(Nc1ccccc1)c1c(O)c(\N =N\c2c (ccc([N+](=O)[O-])c2)C)c2c(ccc c2)c1- InChI:1S/C24H18N4O4/c1-15-11-12-18(28(31)32)14-21(15)26-27-22-19-10-6-5-7-16(19)13-20(23(22)29)24(30)25-17-8-3-2-4-9-17/h2-14,29H,1H3,(H,25,30)/b27-26+- Substance type: Organic- Physical state: Solid powder

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
IGS, SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
Details on test animalTEST ANIMALS- Source: Charles River Japan Co., Ltd.- Age at study initiation: 5 weeks old- Weight at study initiation: The body weight ranged from 116 to 127 g for males and 106 to 124 g for females.- Fasting period before study: Rats fasted for about 17 hours from the day before administration.- Housing: 5 animals (same sex) were housed and raised in polycarbonate cages spread with experimental animal bedding.- Diet (e.g. ad libitum): solid feed- Water (e.g. ad libitum): Freely ingested tap water irradiated with ultraviolet rays after filter filtration with a pore size of 5 μm.- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 2 ° C- Humidity (%): 55 ± 15%- Air changes (per hr): ventilation at about 12times / hour- Photoperiod (hrs dark / hrs light): lighting 12 hours / day (7: 00-19: 00).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Details on exposureVEHICLE- Amount of vehicle (if gavage): 20 mL / kg- DOSAGE PREPARATION (if unusual): The test substance was suspended in a medium containing 0.1% Tween 80 added 0.5% CMC-Na aqueous solution.
Doses:
0, 500, 1000 and 2000 mg/kg
No. of animals per sex per dose:
Total = 30 (sex/dose)
Control animals:
yes
Remarks:
Total = 10 (Male/Female)
Details on study design:
Details on study design- Duration of observation period following administration: 14 days - Frequency of observations: Mortality and general condition were observed over 4 days, 30 minutes, 1, 3 and 6 hours afteradministration, once a day for 14 days, thereafter; and weighing: Body weight was measured using an epple dish balance on days 4, 8 and 15 immediately beforeadministration.- Necropsy of survivors performed: yes- Other examinations performed: Animals were observed for clinical signs.
Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
No mortality was observed at 2000 mg/kg bw.
Clinical signs:
Clinical signs such as, red feces exhibiting the same color tone as the test substance were found between 6 hours and 3 days after administration in males and females of the test substance - administered group, and in all the sexes on the 2nd day. In addition, the coloration of the coat considered to originate from this red flavor was observed in males and females of the test substance-administered group between the 2nd and 4th days. But no abnormality considered to be a toxicity change was observed.
Body weight:
No abnormality was found in body weight of animals.
Gross pathology:
Diaphragmatic hernia in the thoracic cavity was found in one female in the 1000 mg/kg group. In the hernia, the caudate portion of the liver protruded nodularly into the thoracic cavity, a part of which was adhered to the chest wall. Since this change was expressed only in one case and not related to the dose, it was judged as a contingent finding. No other abnormality was found.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
the LD50 value was considered to be >2000 mg/kg bw, when Male and female SD rats were treated with test chemical via oral route.
Executive summary:

Acute oral toxicity study of test chemical was conducted in 40 Crj: CD (SD) IGS, SPF male and female rat at the concentration of 0, 500, 1000 and 2000 mg/kg bw. The test substance (Purity - >99 %; Obtained from - Dainippon Ink & Chemicals, Inc. and lot number - 000207) was suspended in a medium containing 0.1% Tween 80 added 0.5% CMC-Na aqueous solution as 20 mL/kg. Mortality and general condition were observed over 4 days, 30 minutes, 1, 3 and 6 hours after administration, once a day for 14 days, thereafter. Body weight was measured using an epple dish balance on days 4, 8 and 15 immediately before administration.Animals were observed for clinical signs. No death occurred in both males and females.Clinical signs observed such as, red feces exhibiting the same color tone as the test substance were found between 6 hours and 3 days after administration in males and females of the test substance - administered group, and in all the sexes on the 2nd day. In addition, the coloration of the coat considered to originate from this red flavor was observed in males and females of the test substance-administered group between the 2nd and 4th days. But no abnormality considered to be a toxicity change was observed. No abnormality was found in body weight of animals. Diaphragmatic hernia in the thoracic cavity was found in one female in the 1000 mg/kg group. In the hernia, the caudate portion of the liver protruded nodularly into the thoracic cavity, a part of which was adhered to the chest wall. Since this change was expressed only in one case and not related to the dose, it was judged as a contingent finding. No other abnormality was found. Therefore,LD50 was considered to be >2000 mg/kg bw, when Male and female SD rats were treated with test chemical via oral route.