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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402)

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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 8 weeks old
- Weight at study initiation: 234-261 g (males), 175-181 g (females)
- Housing: individually, 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

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm² for males, 18 cm² for females
- Type of wrap: aluminium foil and flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed at the end of the treatment period with a tissue moistened with water

TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: twice daily for mortality; at periodic intervals on day 1 and once daily thereafter for general clinical signs
- Frequency of weighing: on days 1, 8 and 15
- 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: No test item-related clinical signs were noted.

Gross pathology:

At necropsy, bluish discolouration of the epidermis in the treated skin area and of the tail and abdominal fat was observed.

Other findings:

Treated skin abnormalities:
No skin irritation was observed on the treated area during the observation period. Snout, tail, treated skin area and the surrounding skin area were discoloured bluish by the test item.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU