Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Endpoint summary

Description of key information

In an acute oral gavage study no adverse effects were recorded after application of the limit dose.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Standard Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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: 8 weeks
- Weight at study initiation: m: 187-211; f: 157-176
- Fasting period before study: over night
- Housing: Group housing of 5 animals per sex per cage in labelled polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration: 1% in water
- Amount of vehicle (if gavage): 10 mL/kg

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: 14 days
- Frequency of observations and weighing: observations: daily; weighing: weekly
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Clinical signs noted were dark faeces, observed in all animals on day 2, 3 and 4, and. blue discolouration of the skin, observed in all animals between days 2 and 12. Alopecia noted in one female was considered not related to treatment and not toxicologic

Gross pathology:

No findings

Other findings:

none

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight for both sexes.

Executive summary:

Assessment of acute oral toxicity with the test item in the rat.

The study was carried out in accordance with DECO Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 92/69/EEC, Part B.1, "Acute Toxicity-Oral".

The test item was administered by oral gavage to five rats of each sex at 2000 mg/kg body weight.

Animals were subjected to daily observations and weekly determination of body weight.

Macroscopic examination was performed at the end of the experimental period.

No mortality occurred during the study period. Treatment related clinical signs observed during the study were dark faeces (days 2-4) and blue discolouration of the skin (between days 2 and 12). The body weight gain over the study period shown by the animals was considered to be similar to that expected of normal untreated animals of the same age and strain. Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

The oral LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight for both sexes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

reliable

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral gavage study no adverse effects were recorded after application of the limit dose of 2000 mg/kg bw.

As the findings in the other available study in female animals only could not be reproduced when using a fresh batch of the test meterial, these finding were regarded as due to an unknown impurity, which appeared to be much more bioavailable as indicated by dark discoloration of the skin observed in most animals in this study.

Findings (clinical signe, mortality) were not reported consistently in this study. The study was disregraded.

Justification for selection of acute toxicity – oral endpoint
The findings in the other available study in female animals only could not be reproduced when using a fresh batch of the test meterial. This other report contains conflicting information regarding group 2 females.

Justification for classification or non-classification

no classification

No adverse effects were noted at the limit dose of 2000 mg/kg bw in rats.