Chromium, 3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonic acid complex

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following official guideline not GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black 52

IUPAC Name:

Acid Black 52

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Source: Breeding Farm VELAZ
Sex: male
Animal body weight: range 130-170 g
Acclimtisation: minimum 5 days
Total number: 6 males for orientatio study
10 males per dose group for mian study
Housing: animal room with monitored conditions 3-5 animals in one plastic cage Velaz T4
Diet: standard pelleted diet VELAZ
Water: drinking tap water ad libitum
Microclimatic conditions: room temperature 22+/-3°C permanently monitored
relative humidity 30-70% permanently monitored
light: 12 hours light/12 hours dark
Bedding: sterilized shaving of soft wood
Randomisation: according to the internal rule, at the start of the study the weight variation of animals was minimal and did not exceed +/-20% of the mean weight for each sex
Identification of animals: colour marks 1-3 in orientation study and 1-5 in main study on tail of animals, each cage was marked with the number of study, sex and dose of the test item
Health conditions: certificate of good health conditions-from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the start of study

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Immediately before application the test item was weighed, mixed in vehicle ( water for injection) and resulting suspension was administered to the stomach by tube.

Doses:

5020, 6310 and 7943 mg/kg bw for the main study
in the orientation study the following doses were used: 10000 mg/kg and 5000 mg/kg

No. of animals per sex per dose:

10 males per dose for the main study
3 males per dose for the orientation study

Control animals:

no

Details on study design:

PREPARATION OF EXPERIMENTAL ANIMALS
About 20h before the oral administration the animals were not fed, water was given ad libitum.
Immediately before application the animals were weighed and distributed to groups with 3 animals to orientation part of the study and group of 10 aniamls for the main study.
The animals were fed 3 hours after application of the test item

BODY WEIGHT RECORDING
Animals were weighed before application and at day 15, before euthanasia of animals. Average body weight within a group was calculated from individual body weigths. Body weight increments were calculated from body weight at the start of the study and at the end of the study.

CLINICAL EXAMINATIONS
After application the animals were observed individually
1st day: at 30min and at 3h
2nd day: in the morning and in the afternoon
up to 14th day: once daily
Observations included: changes in the skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.

PATHOLOGICAL EXAMINATION
All the test animals that survived to the end of the study were sacrificed on the 15th day and gross necroscopy was performed. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

6 857 mg/kg bw

Based on:

test mat.

Mortality:

Death of animals occured in all dose groups

dose: 5020 mg/kg bw, 1 male died at day 1
dose: 6310 mg/kg bw, 2 males died at day 1
dose: 7943 mg/kg bw, 3 males died after 3 hours, 7 males died at day 1

Clinical signs:

other: The test item caused diarrhoea and faintness in the period up to 3 hour after administration. After 24hours after application the diarrhoea receded. Other finding during clinical observations were normal.

Gross pathology:

The test item caused colouration of organs while other patho-morfological signs were not found.

Applicant's summary and conclusion

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for acute toxicity oral following OECD 401. The LD50 was found to be equal to 6857 mg/kw bw.

Executive summary:

The substance was tested for acute toxicity oral following OECD 401. The LD50 was found to be equal to 6857 mg/kw bw.