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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Experimental data from study report

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
1962
Reference Type:
other: secondary source
Title:
Water Quality Criteria for Colored Smokes: Solvent Green 3
Author:
Kowetha A. Davidson and Patricia S. Hovatter
Year:
1986
Bibliographic source:
U.S. Army Medical Research and Development Command, Fort Detrick Frederick, Maryland 21701-5012, Army Project Order No. 86PP6810, December 1987, page no 1-95.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Subchronic repeated dose oral toxicity study of test chemical in rats.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-bis(p-tolylamino)anthraquinone
EC Number:
204-909-5
EC Name:
1,4-bis(p-tolylamino)anthraquinone
Cas Number:
128-80-3
Molecular formula:
C28H22N2O2
IUPAC Name:
1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: 1,4-bis(p-tolylamino)anthraquinone (Solvent Green 3)- Substance type: Organic- Physical state: Solid
Specific details on test material used for the study:
- Name of the test chemical: D and C green 6
- IUPAC name: 1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Substance type: Organic

Test animals

Species:
rat
Strain:
not specified
Details on species / strain selection:
No data
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: feed
Details on route of administration:
No data
Vehicle:
other: Diet
Details on oral exposure:
No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
100 other: mg/kg bw
Remarks:
Concentration : 0.1%
Dose / conc.:
230 other: mg/kg bw
Remarks:
Concentration: 0.23%
Dose / conc.:
550 other: mg/kg bw
Remarks:
Concentration: 0.55%
Dose / conc.:
1 290 other: mg/kg bw
Remarks:
Concentration: 1.29%
Dose / conc.:
3 000 other: mg/kg bw
Remarks:
Concentration: 3.0%
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data
Positive control:
No data

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes, survival were observed .

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes

FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data


Sacrifice and pathology:
GROSS PATHOLOGY: No data

HISTOPATHOLOGY: Yes
Other examinations:
No data
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
effects observed, treatment-related
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
no effects observed
Other effects:
not specified
Details on results:
Mortality:
No effect on survival of treated rats were observed.

Clinical sign:
No signs of toxicity were observed in treated rats.

Body weight:
Body weights were within normal range.

Food consumption:
Food consumption were within normal range.

Gross pathology:
When treated with 550 and 3000 mg/kg/day, small thyroid gland and gross degenerative changes in the liver were observed in the treated rats.

Histopathology:
When treated with 550 and 3000 mg/kg/day, increase in vacuolated cells around the hepatic central vein of liver were observed in treated rats.

Effect levels

Dose descriptor:
NOAEL
Effect level:
230 other: mg/kg bw
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: No effect on survival, body weight, food consumption and gross pathology
Remarks on result:
other: No toxic effects were observed

Target system / organ toxicity

Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified

Applicant's summary and conclusion

Conclusions:
The No observed adverse effect level (NOAEL) was considered to be 230 mg/kg bw/day when rats were treated with test chemical orally in feed for 6 weeks.
Executive summary:

In a 6-week dose range-finding study in rats, test chemical was administered in the diet at concentrations of 0.1, 0.23, 0.55, 1.29, or 3,0 percent (100, 230, 550, 1290 or 3000 mg/kg bw). There were no deaths or gross signs of toxicity. Food consumption and body weights were within normal range. The thyroid gland was small in animals fed the 0.55 (550 mg/kg bw/day) and the 3.0 (3000 mg/kg bw/day) percent diets, but histopathological evaluation did not reveal abnormalities in the thyroid gland. Gross degenerative changes in the liver were observed and confirme the by histopathological examination, which showed an increase in vacuolated cells around the hepatic central vein. No other effects were observed. Therefore, the No observed adverse effect level (NOAEL) was considered to be 230 mg/kg bw/day when rats were treated with test chemical orally in feed for 6 weeks.