Reaction products of 4-amino-3-hydroxy-7-nitronaphthalene-1-sulfonic acid and 2′,4′-dihydroxyacetophenone chelated with iron, sodium salts

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Source study has reliability 1. Details on the read across are available in 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

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

solid: particulate/powder

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 16 h, with water ad libitum
- Housing: single housing in stainless steel wire mesh cages, Type DLK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

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

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: Feces of male and female animals were black discoloured. 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:
Day 1 - day 2: piloerection (2/3 animals)
Hour 4 - day 2: discoloured feces (black) (3/3 animals)
Hour 4 - day 3: black smeared fur in the anogenital area (2/3 animals)

- Females:
Hour 1 - day 1: discoloured feces (black) (3/3 animals)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

Method:

Acute oral toxicity in rats was assessed following OECD guideline 401. A dose of 2200 mg/kg bw was administered by gavage 3 rats/sex. A 14-days observation period followed dosing.

Results:

No mortality was recorded, thus LD₅₀ > 2200 mg/kg. Black discoloured feces were noted in both males and females; in males piloerection was also noted.