Reaction mass of Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)Vinyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)]-, sodium and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[2-(sulfooxy)Ethanol]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt

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

Study period:

From June 22 to July 6,1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Complete read across justification is attached in section 13. Source study has reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1979

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

RA Substance 01

IUPAC Name:

RA 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: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: male 179 g , female 187 g
- Housing: 5 rats/cage in Macrolon cages type IV
- Fasting period before study: 16 hrs before the treatment and 2 hrs after
- Diet : Rattendiät Altromin 1324 , ad libitum
- Water : ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hrs cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

demineralized

Details on oral exposure:

Concentration 25% (w/v) in water
Dose: 5000 mg/kg bw
Application volume: 20 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: once a week
- Frequency of clinical observations: multiple times on day 1, twice daily thereafter
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 800 mg/kg bw

Based on:

act. ingr.

Mortality:

One female died within 3 hours after dosing. As the lung was bluish discoloured, it may be that part of the test substance was inhaled during gavage.

Clinical signs:

other: On day 1, males + females showed reduced activity, pale skin; from 2 hours onwards bluish discolored skin. On day 1 and 2, bluish discolored feces were reported. Female rats, from 2 hours until end of day 1 showed hunched posture; one animal showed narro

Gross pathology:

Death female showed blue liquid in gastrointestinal tract; lung partially bluish discoloured; skin light bluish discoloured. One male showed lung reddish discoloured.
All other rats were without abnormal findings.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to CLP Regulation (EC 1272/2008)

Conclusions:

Based on result after 14-day observation period, test substance is considered as non toxic by oral administration with LD50 > 5000 mg/kg.
More precisely, LD10 = 5000 mg/kg, corresponding to 1800 mg/kg as active ingredient.

Executive summary:

Method

Test substance was tested in male and female Wistar rats at a dose of 5000 mg/kg bw.

Results

Test substance showed a medium lethal dose (LD50) of above 5000 mg/kg bodyweight in male and female rats. In particular, 5000 mg/kg, i.e. 1800 mg/kg as active ingredient, corresponded to a LD10 value.