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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from authoritative database.

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Single Dose Oral Toxicity study of the given test chemical in rats
Author:
J-CHECK
Year:
2010
Bibliographic source:
J-CHECK , 2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of the given test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- 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+
- Smiles: O=C(Nc1ccccc1)c1c(O)c(\N=N\c2c(ccc([N+](=O)[O-])c2)C)c2c(cccc2)c1
- Common Name: CI Pigment Red 22
- Molecular formula :C24H18N4O4
- Molecular weight :426.43 g/mol
- Substance type:Organic
- Physical state:powder
- Purity: >99 %
- Impurities (identity and concentrations):<1%

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
IGS, SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST 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 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ° C
- Humidity (%): 55 ± 15%
- Air changes (per hr): ventilation at about 12 times / 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:
VEHICLE
- 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:
- 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 after
administration, 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 before administration.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
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:
not specified

Applicant's summary and conclusion

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

Acute oral toxicity study of the given 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 %) 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, the acute oral LD50 value was considered to be >2000 mg/kg bw, when Male and female SD rats were treated with the given test chemical via oral route.