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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:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
The test material, suspension in liquid water was administered by intragastric infection to young Adult ChR-CD male rats in single doses. Survivors were sacrificed 14 days later.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name (IUPAC): 4-{bis[4-(dimethylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium chloride
- Name of test material (as cited in study report): Gentian Violet
- Molecular formula: C25H30ClN3
- Molecular weight: 407.986 g/mol
- Smiles notation): CN(C)C1=CC=C(C=C1)C(=C2C=CC(=[N+](C)C)C=C2)C3=CC=C(C=C3)N(C)C.[Cl-]
- InChl : InChI=1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
other: ChR - CD
Sex:
male

Administration / exposure

Route of administration:
other: Oral : distilled water
Vehicle:
other: Intragastric intubation
Doses:
11,000
7,500
5,000
3,400
2,250
1,500
1,000
670
450
200
130

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: Approximate Lethal Dose
Effect level:
670 mg/kg bw
Based on:
test mat.
Mortality:
Suspension Dose Mortality
% + (Mg/Kg)+
50 11,000 D-1
50 7,500 D-3 ½ hrs
50 5,000 D-4 ½ hrs
50 3,400 D-2 d.
50 2,250 D-2 d.
50 1,500 D-5 d.
25 1,000 D-4 d.
5 670 D-7 d.
5 450 S-14 d.
5 200 S-14 d.
5 130 S-14 d.
Clinical signs:
Lethal Dose-Stained perineal area, eyes half closed, lethargy, Weakness, Ruffed coat, Diarrhea, pallor and irregular respiration; Salivation, anuria and mucoid diarrhea at 2,250 mg/kg and above; belly-to-cage posture at 3,400 mg/kg and above; weight loss.

Non-lethal Dose- Lethargy on second day after dosing, stained perineal area and weakness on the third day after dosing; Half closed eyes and ruffed coat on fourth day after dosing at 450 mg/kg; initial weight loss for three to four days.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: other: Test Result
Executive summary:

Du Pont paper Blue R solution is slightly toxic when administered to young adult ChR -CD male rats in single doses; it’s approximate lethal dose(ALD) is 670mg/kg of body weight. since the oral LD50 for acetic acid alone is approximately 3,300 mg/kg for rats, it would appear that the Relatively high toxicity observed with the subject compound cannot be explained by the presence of acetic acid in the mixture.