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Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method

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
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: s.p. Valez, Prague.
- Weight at study initiation: 220 - 248 g.
- Housing: plastic polypropylene cages T3.
- Diet: commercial produced granulated feed mixture Altromin 1320. ca 20 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

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: animals were twice depilated in back coat, involving an area of 6 × 6 cm.
- Type of wrap if used: the sample was covered with gauze, aluminum foil, technical tape around the perimeter of the hull. The dressing was covered with technical tape and clamped so that the test substance is maintained in contact with the skin so as to avoid ingestion.

TEST MATERIAL
- Application: in paste form.
Duration of exposure:
24 hours
Doses:
5.020 g/kg
No. of animals per sex per dose:
6 animals
Control animals:
yes
Remarks:
gauze soaked in acetone butyl alcohol in ratio 1: 1, then with gauze soaked in saline
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 color, 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
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Clinical signs:
Throughout the experiment no clinical symptoms of intoxication were observed. Visual check revealed that coat, skin and visible mucous membranes appeared without abnormalities. It was also found good nutritional status, normal mental and motor activity, reactivity and sensibility. Functionality of the circulatory, respiratory, digestive and urogenital apparatus resulted to be normal.
Body weight:
Normal weight gain.
Gross pathology:
Subcutaneous tissue and muscle, head, neck, stomac and intestine did not show macroscopic pathomorfological changes.
Lung: pinkish color, spongy, airy, without macoscopic pathomorfological changes.
Heart: maroon, stiffer consistency, without macoscopic pathomorfological changes.
Liver: dark-brown-red color, a stiffer consistency, without macroscopic pathomorphological changes.
Spleen: reddish-brown color, stiffer consistency, without macroscopic pathomorphological changes.
Kidney: reddish-brown color, smooth surface, stiffer consistency, without 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 5000 mg/kg bw.
Executive summary:

Method

The acute dermal toxicity of the substance has been assayed following the testing procedures outlined into the OECD guideline 402. The substance was administered, as paste, by occlusive application on 6 rats; a single dose of 5000 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, the surviving animals were killed and dissected.

Results

Throughout the experiment no clinical symptoms of intoxication were observed. Visual check revealed that coat, skin and visible mucous membranes appeared without abnormalities. It was also found good nutritional status, normal mental and motor activity, reactivity and sensibility. Functionality of the circulatory, respiratory, digestive and urogenital apparatus resulted to be normal. Subcutaneous tissue and muscle, head, neck, stomac and intestine did not show macroscopic pathomorphological changes.

The LD50 resulted to be greater than 5000 mg/kg.