Sodium 1-amino-9,10-dioxo-4-(2,4,6-trimethylanilino)anthracene-2-sulfonate, reaction products with acidified C10-14-tert-alkyl(linear and branched) amines

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD test guideline 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methylundecan-2-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate

EC Number:

700-958-6

Molecular formula:

UVCB Substance

IUPAC Name:

2-methylundecan-2-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate

Details on test material:

- Description: blue powder
- Expiration date of the batch: 01-Apr-1997
-Stability under storage conditions: stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd, Basel, Switzerland
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 218-271 g (males), 163-186 g (females)
- Housing: 5 animals/sex/cage in polycarbonate cages
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: dose volume of 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle for studies of this type

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: at periodic intervals on day 1 and once daily thereafter
- Frequency of weighing: twice daily for mortality; at periodic intervals on day 1 and once daily thereafter for general clinical signs
- Necropsy of survivors performed: yes

Results and discussion

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 noted at the limit dose level.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Clinical signs included: salivation (3/10 animals) on day 1, blue faeces (10/10 animals) on days 2-5 and hunched posture (1/10 animals) on day 11.

Gross pathology:

There were no macroscopical findings in males. In females, greyish discolouration of abdominal fat and enlarged stomach with watery contents were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU