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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: WISTAR rats Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River, 97633 Sulzfeld, Germany- Age at study initiation: 8-9 weeks- Weight at study initiation: Step 1 (animals 1-3): 159 - 166 g; Step 2 (animals 4-6): 152 - 155 g- Fasting period before study: Food was withheld from the test animals for 16 to 19 hours prior to the administration.- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0856)- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 55 ± 10- Air changes (per hr): 10- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE- Concentration in vehicle: 200g/LMAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 females per step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing. Thereafter, the animals were observed for clinical signs once daily. The animals were weighed on day 1 (prior to the application) and on days 8 and 15.- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occured.
Clinical signs:
Clinical signs within the first 3 days after application comprised among others of piloerection, half eyelid-closure, tremor, reduced spontaneous activity, catalepsis and kyphosis. No clinical signs were observed thereafter.
Body weight:
No effects on body weight observed.
Gross pathology:
No findings upon necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified