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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25/8/1988-8/9/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
The test material: Chromoxyd Dyko
- State of aggregation: green powder
- pH: 7 - 8
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: storage at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: males: ca. 9 weeks; females ca. 14 weeks
- Weight at study initiation(mean): males: 175 g: females: 172 g
- Fasting period before study: ca. 16 hours before test item administration and up to 4 hours after test item administration food was withdrawn.
- Housing: five animals/cage; Macrolon cage Typ III with dustfree wood pelletes (manufacturer: Firma Ssniff, Soest/Westfalen)
- Diet (ad libitum, for exception please refer to "Fasting period before study" above): "fixed-formula"- standard diet AltrominR1324 pellets (Manufacturer: Altromin GmbH, Lage)
- Water (ad libitum): drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 50 ± 10 %
- Air changes: ca. 10 air changes/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSAGE PREPARATION:
The test material was suspended in water at room temperature. The test material was formulated prior to administration. A homogeneous mixture was accomplished by stirring.
Animals were dosed using a constant application volume of 20 mL/kg bw.
The application volume was calculated based in the individual body weight of the animals determined prior to test item application.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the day of the application, the animals were inspected several times and during the following 14-day observation period twice a day (once on weekends and holidays). The type, onset, duration and intensity of the clinical symptoms were recorded and any dead animals were removed. The time of death was recorded. At the end of the experiment animals were randomly selected for necropsy.
At application day, day 7 and at the end of the 14-day observation period, the surviving animals were individually weighed.
- Necropsy performed: yes, all deceased and surviving animals were macroscopically examined..
Statistics:
Statistical analysis not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Clinical signs were limited to piloerection (one male and one female) and salivation (all animals) starting 15 minutes following dosing; signs had resolved within 8 hours.
Body weight:
Slight weight loss was apparent in two females during the second week of the study. The body weight of the males was not effected.
Gross pathology:
There were no findings attributable to treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (male rats) > 5000 mg/kg
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.