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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995, november-december
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (non-GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Direct Red 239
IUPAC Name:
Direct Red 239
Details on test material:
- Name of test material: Rybacelová červeň E-2GF tekutá
- EC: 249-171-5
- CAS: 28706-25-4

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: VUFB Praha
- Weight at study initiation: ± 200 g
- Housing: During the experiment animals were housed in cages T4
- Diet: 10gram/animal/day. Standard feed mixture ST-1, available on the market provided by Bergman Kocanda mill. The nutritional composition of the diet provides an optimal and genuine nutrition. It wasn't positive to aflatoxin test.
- Water: drinking water, according to CSN 757111 ad libitum.
- Acclimation period: rats were housed in three cages T4 plastic polypropylene (supplied by TOP Velaz sro Praha) and separated by sex, for 1 week
- Bedding: were used softwood shavings

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 15%
- Photoperiod: 12 hours dark and 12 hours light

Other informations:
- On delivery, weighed on average about 150 grams and the supplier has provided a certificate guaranteeing that the animals were not affected by pests, pathogens and molds.
- To prevent infections has been conducted regularly cleaning and disinfecting cages, following standard operating procedures.

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The sample was applied in pure form, in the form provided.
The amounts to be applied to the sample, were measured as necessary to ensure the limit of 5.020 ml/kg

Duration of exposure:
24h of exposure and 14 days of observation
Doses:
5.020 ml / kg
No. of animals per sex per dose:
5
Details on study design:
Preparation of animals::
The experimental animals was shaved back area of 6x6 cm with an electric razor.

Preliminary procedures:
The skin of the back was shaved clean with a gauze soaked in a mixture of acetone - ethanol 1:1 and then with a gauze soaked in saline.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
No signs
Clinical signs:
No observed
Body weight:
Slight decrease in body weight
Gross pathology:
At autopsy, animals killed after 14 days of the observation period did not present patho-morphological changes.

Any other information on results incl. tables

There were no signs of intoxication.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Substance is practically nontoxic after single dermal contact.

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