Reaction products of diazotised 2-amino-1,5-naphthalene sulfonic acid coupled with resorcinol, subsequently coupled with diazotized 2-amino-4,6-dinitrophenol, chelated with iron

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

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:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

Department of Toxicology, BASF AG

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 360 - Similar Substance 01

IUPAC Name:

Acid Brown 360 - Similar Substance 01

Test material form:

not specified

Details on test material:

- Color index: Acid Brown 434
- Substance number: 92/100
- Date of manufacturing: 21-May-1992
- Physical state: powder, black
- Lot/batch No.: 6426/6079
- Storage condition of test material: refrigerator

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. Thomae GmbH, D-7950 Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: mean 181 g (males), 174 g (females)
- Fasting period before study: at least 16h, with water ad libitum
- Housing: single housing in stainless steel wire mesh cages, Type DLK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Concentration of test material in vehicle: 11%
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: aquous formulation corrresponds to the physiological medium


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

2200 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 day
- Frequency of observations and weighing: recording of signs and symptomps several times on the day of administration, at least once each workday; individually body weights shortly before application (day 0), and on days 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: In the male and female animals was black discolored feces. Males additionally exhibited piloerection and black smeared fur in the anogenital area

Gross pathology:

No pathological findings

Other findings:

Symptoms after administration of 2200 mg/kg bw of test material in vehicle by gavage:

Males:
day1-day2: piloerection (2/3 animals)
hour4-day2: discoloured feces (black) (3/3 animals)
hour4-day3: black smeared fur in the anogenital area (2/3 animals)

Females:
hour1-day1: discoloured feces (black) (3/3 animals)

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 (rat, oral) > 2200 mg/kg bw

Executive summary:

This study (according to EEC/OECD) shows that the LD50 (rat,oral) is >2200 mg/kg bw. No mortality or gross pathological changes were observed.