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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May to August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test performed according to OECD/EU testing guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Absorbent N grade A
IUPAC Name:
Absorbent N grade A
Details on test material:
- Name of test material (as cited in study report): Absorbent N grade A
- Substance type: UVCB
- Physical state: Brown liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature, in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: from the copany Charles River Deutschland GmbH, D-97633, Sulzfeld
- Age at study initiation: data not available
- Weight at study initiation: between 150g and 178g
- Fasting period before study: yes
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 cm2) with 3 in each cage. the cages were cleaned and the bedding changed at least twice a week.
- Diet: free access to a pelleted diet "Altromin 1324"
- Water: free access to bottles of drink water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: at least 30% and preferably not exceed 70%
- Air changes: 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 24-MAY-2011 to 31-MAY-2011

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: data not available

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: data not available
Doses:
300 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
4 x 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> each rat was observed 30 minutes, 2 hrs, 4hrs and 6hrs after the administration and therafter daily for a period of 14 consecutive days
> the body weight was determined on days 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
female
Effect level:
300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: All 6 animals survived not showing severe signs of toxicosis
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 5 animals survived showing slight to moderate signs of toxicosis, 1 animal died.
Mortality:
All six animas survived the treatment with the test item at a dosis of 300 mg/kg bw.
5 animals survived showing slight to moderate signs of toxicosis, 1 animal died.
Clinical signs:
On the day of application after 30 minutes and 2 hrs piloerection was observed in animal No. 1, No. 2 and No. 3 (group 1) receiving a dose of 300 mg/kg b.w. After 4 hrs and 6 hrs as well as from day 1 to the end of the observation period on day 14 all animals were free of any abnormalities.

On the day of application after 30 minutes piloerection was observed in animal No. 4, No. 5 and No. 6 (group 2) receiving a dose of 300 mg/kg b.w. These rats showed a hunched posture and piloerection after 2 hrs, whereas only piloerection was observed after 4 hrs. All animals were free of abnormalities after 6 hrs as well as from day 1 to the end of the observation period on day 14.

On the day of application after 30 minutes piloerection was observed in animal No. 7 and No. 8 (group 3) receiving a dose of 2000 mg/kg b.w., whereas animal No. 9 showed a hunched posture and piloerection. After 2 hrs, 4 hrs and 6 hrs a hunched posture and piloerection were revealed in the three rats. In addition, animal No.9 showed apathy after 4 hrs and 6 hrs. Piloerection was still observed in the animal No. 7 and No. 8 on day 1 and rat No. 9 was dead. The surviving animal No. 7 and No. 7 were free of abnormalities from day 2 to the end of the observation period on day 14.

On the day of application after 30 minutes a hunched posture and piloerection were observed in animal No. 10, No. 11 and No. 12 (group 4) receiving a dose of 2000 mg/kg b.w. The three rats showed a hunched posture and a tremor after 2 hrs. A hunched posture and and piloerection were also observed after 4 hrs and 6 hrs. The three animals still showed piloerection on day 1 and 2. From day 3 to the end of the observation period on day 14 all animals were free of any abnormalities.
Body weight:
The development of the body weight was normal in all surviving animals.
Gross pathology:
There were no pathological signs detected in the necropsy, with exception of animal No. 9.
This rat showed slight bloody discharge from the nose and watery discharge from the mouth as well as lungs with very light colour and red dark blood.
Cramped limbs, slight bloody discharge from nose and mouth as well as a stomach filled partly with food and gas were also revealded in rat No. 11. Furthermore, the mucosa of the jejunum was hemorrhagic centrally and the content was sero hemorrhagic.
The animal No. 12 showed cramped limbs, slight bloody discharge from nose and mouth, petechial bleedings in the lungs, an edematous small intestine and slight sero hemorrhagic content.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
oral LD50 (rat, females) above 2000 mg/kg bw
Executive summary:

The oral LD50 of the test item in rats was found to be above 2000 mg/kg bw under the experimental conditions described in the final report. In accordance with the GHS, the test item should be categorized into category 5.