Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Minor deviations without an effect on the results: - According to the guideline, normally females are used for this test. In this study 3 males and 3 females were used for testing the acute toxicity. -According to the guideline, healthy young adults between 8 and 12 weeks of age should be used. The age of the animals was not stated in the study. It was only stated that the animals were young and healthy. - According to the guideline, the relative humidity in the animal room should be 30 - 70 %. The relative humidity in the study was slightly higher (55+/- 25 %). -According to the guideline, three animals are tested and depending on the outcome the next three animals are tested. In this study all animals were tested at the same time. -According to the guideline, the animals are observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first four hours, and daily thereafter, for a total of 14 days, except where they need to be removed from the study. In the report, it was only stated that on the first day regular observations were performed, in the following days the animals were observed at least once until the 14 day. - According to the guideline, details on food and water quality must be included in the study report, which was missing in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical state: Not stated, but it is common knowledge that this test substance is a solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: provided by an authorised supplier
- Weight at study initiation: Males: 135 g, 135 g and 133 g; Females: 113 g, 116g and 120 g
- Fasting period before study: The animals fasten during the previous night. After 3 hours of administration, feeding was restored.
- Housing: Housed in groups of three; Makrolon cages (48 X 27 X 20 cm), brand Tecniplast, with wooden bed
- Diet (ad libitum): Diet for experimental rats, provided by an authorised provider
- Water (ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C (+/- 2°C)
- Relative humidity: 55 % (+/- 25 %)
- Air: Renewed 15 times per hour and prefiltered at 5 µm
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
2000 mg of sample was diluted in 20 mL of distilled apirogenic water.

MAXIMUM DOSE VOLUME APPLIED: 2 mL of the diluted sample per 100 g of alive weight, equivalent to the 2000 mg/kg of alive weight were administrated (sample was vigorously stirred before administration).

CLASS METHOD
- Rationale for the selection of the starting dose: The available information suggested that the sample is little toxic and the limit test was performed.
No further information on the oral exposure was stated.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 males / 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The individual weight control was performed at the beginning of the study, before administration, after 7 days of administration and at the end of the study or in case of having had a death, right after death. A general clinical exam was performed every working day in which modification were observed. The first day regualr observations were performed, in the following days the animals were observed at least once until the 14 days. the observed signs of toxicity were observed, at the moment of appearance and also the time for recovery.
- Necropsy of survivors performed: Yes
After the study, the surviving animals were sacrificed by means of a humanitarian method (cervical dislocation). All the animals in the study were subjected to macroscopic necropsy. Macroscopic pathology changes for each animal were noted.
- Other examinations performed: During clinical examination modification were observed and noted in among others: Skin, hair, eyes, mucosity, respiratory track, circulatory system, central and autonomous nervous system, motion activity and behavioural lines of action. With special care for: shaking, convulsions, salivation, diarrhea, lethargy, sleep and coma.
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All the animals administrated with the sample survived normally until the 14 days of observation.
Clinical signs:
Neither abnormal effects nor any toxicity signs that could be attributed to the sample were observed.
Body weight:
The registered weight variations can be regarded as normal for these animals (males and females).
Gross pathology:
Necropsies were performed after 14 days of administration of the sample in the test animals, without observation of relevant macroscopic changes in any of them.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The sample submitted as "VERDE D7" (B2240) (Hematite chromium green black) , studied under the described method, presents an acute toxicity -LD50 by oral route in rat: above 2000 mg/kg.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic.