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Toxicological information

Acute Toxicity: oral

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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:
Details on the read across are reported in section 13. Source study has reliability 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Yellow 049 acid
IUPAC Name:
Acid Yellow 049 acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: s.p. Valez, Prague.
- Weight at study initiation: females 160 - 170 g; males 150 - 156 g.
- Fasting period before study: day before application.
- Housing: plastic polypropylene cages T4.
- Diet: commercial produced granulated feed mixture Altromin 1320. ca 15 g/item/day
- Water: ad libitum.
- Acclimation period: one week.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Appropriate amount of sample needed to prepare a 20 % aqueous suspension was weight, for the selected dose level of logarithmic. The sample was added to a calculated volume of water and thorough stirring with a glass rod.
- Log. dose level: 15.85 g/kg
- Sample weight: 36.00 g
- Added to the volume of water: 180 ml
Doses:
15000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: immediately after application, i.e. within 30 minutes, 3 hours after application, the following morning and afternoon and the next day at least once a day, for 14 days. Clinical diagnosis was focused on observing the appearance of skin, hair, visible mucous and nutritional status, mental activity, somatomotor activity, responses to stimuli, focusing on sensibility and reactivity, lacrimation, functional assessment of the respiratory, digestive, urogenital and circulation system.
- Necropsy of survivors performed: yes. Animals that died during the experiment are weighed and dissected; the surviving animals were weighed after 14 days, killed and dissected. Organs and muscle examined macroscopically. After exenterations internal organs were judged according to their colour, size, consistency and structure. If the post mortem bladder resulted to be filled with urine, the urine biochemical tests were carried out focusing on finding proteins, blood sugar, ketone, bilirubin, urobilinogen and pH.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Clinical signs:
other: Throughout the experiment no clinical symptoms of intoxication were observed. Visual check revealed that coat the skin and visible mucous membranes appeared without abnormalities. Good nutritional status, normal mental and motor activity, reactivity and s
Gross pathology:
Hair, skin and visible mucous membranes: a normal appearance.
The subcutaneous tissue and muscle did not show macroscopic pathomorphological changes.
Nutritional status: good.
Lungs pinkish color, spongy, airy without macroscopic pathomorphological changes.
Heart: maroon, stiffer consistency, without macroscopic pathomorphological changes.
Liver: dark reddish-brown color, smooth surface, stiffer consistency.
Spleen: reddish-brown color, stiffer consistency, without macroscopic pathomorphological changes.
Kidney: maroon on a smooth surface, stiffer consistency, without macroscopic pathomorphological changes.
Head, neck, stomac, gut and bladder did not show macroscopic pathomorphological changes.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 is greater than 15000 mg/kg
Executive summary:

Method

The acute oral toxicity of the substance has been assayed following the testing procedures outlined into the OECD guideline 401. The substance was administered, as water solution, by gavage to 10 rats, i.e. 5 males and 5 females; a single dose of 15000 mg/kg was given. Animals were observed for the successive 14 days. Clinical diagnosis was focused on observing the appearance of skin, hair, visible mucous and nutritional status, mental activity, somatomotor activity, responses to stimuli, focusing on sensibility and reactivity, lacrimation, functional assessment of the respiratory, digestive, urogenital and circulation system. At the end of the observation period, surviving animals were killed and dissected.

Results

Throughout the experiment no clinical symptoms of intoxication were observed.

Main observations were:

- lungs: pinkish colour, spongy, airy, without macroscopic pathomorphological changes;

- heart: maroon, with stiffer consistency, without macroscopic pathomorphological changes.

- liver: dark reddish-brown color, smooth surface, stiffer consistency.

- spleen: reddish-brown color, stiffer consistency, without macroscopic pathomorphological changes.

- kidney: maroon on a smooth surface, stiffer consistency, without macroscopic pathomorphological changes.

- head, neck, stomac, gut and bladder did not show macroscopic pathomorphological changes.

The LD50 resulted to be greater than 15000 mg/kg.