1,4-bis(p-tolylamino)anthraquinone

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

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

Reference

Reference 1

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.

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1965

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

13 weeks subchronic repeated dose toxicity study of test chemical in rabbits was conducted to evaluate the adverse effects by dermal route.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Solvent Green 3

IUPAC Name:

Solvent Green 3

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Solvent Green 3
- Molecular formula (if other than submission substance): C28H22N2O2
- Molecular weight (if other than submission substance): 418.4938 g/mole

- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available

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:

rabbit

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

Type of coverage:

not specified

Vehicle:

other: Petroleum or hydrophilic base

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: Solvent Greer 3 suspended in either petroleum or hydrophilic base at 0.1 or 1,0 percent.


TEST SITE
- Area of exposure: Skin
- % coverage: No data available
- Type of wrap if used: No data available
- Time intervals for shavings or clipplings: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 or 1.0 %
- Concentration (if solution): No data available
- Constant volume or concentration used: No data available
- For solids, paste formed: No data available

VEHICLE
- Justification for use and choice of vehicle (if other than water): Petroleum or hydrophilic base
- Amount(s) applied (volume or weight with unit): 0.1 or 1.0 %
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

USE OF RESTRAINERS FOR PREVENTING INGESTION: No data available

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

15 times in 13 weeks

Doses / concentrations

Dose / conc.:

500 other: mg/kg

No. of animals per sex per dose:

No data

Control animals:

not specified

Details on study design:

No data

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data available

DERMAL IRRITATION (if dermal study): No data
- Time schedule for examinations: No data

BODY WEIGHT: No data
- Time schedule for examinations: No data

FOOD CONSUMPTION: No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data

FOOD EFFICIENCY: No data
- 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: No data
- Time schedule for examinations: No data

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes

HISTOPATHOLOGY: Yes

Other examinations:

No data

Statistics:

No data

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

not examined

Mortality:

no mortality observed

Body weight and weight changes:

not examined

Food consumption and compound intake (if feeding study):

not examined

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 specified

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Details on results:

Clinical signs: No local toxic effect were observed in treated rabbits.

Gross pathology: No systemic toxic effects were observed in treated rabbits.

Effect levels

Dose descriptor:

NOAEL

Effect level:

500 other: mg/kg

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: No effects on clinical sign and gross pathology was observed.

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 Adeverse Effect Level (NOAEL) was considered to be 500 mg/kg when rabbits were treated with test chemical for 13 weeks.

Executive summary:

Repeated dose dermal toxicity were evaluated in rabbit by using test chemical.The test chemical was applied at a dose of 500 mg for 13 weeks. No local toxic and no systemic toxic effects were observed in treated rabbits. Therefore, the No observed Adeverse Effect Level (NOAEL) was considered to be 500 mg/kg when rabbits were treated with test chemical for 13 weeks.