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Administrative data

Description of key information

The acute toxicity of KGD 1409 is > 5000 mg/kg bw (LD50 cut-off) after oral administration (Schüngel, 2003)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan to Feb 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 38
- Purity: 100 %
- Expiration date of the lot/batch: 2003-03-12
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: Harlan-Winkelmann GmbH (Borchen, Germany)
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 157-176 g
- Fasting period before study: 16-24 hours
- Housing: in groups
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
other: demineralized water with the aid of 2 % Cremophor EL
Details on oral exposure:
RATIONALE FOR THE SELECTION OF THE STARTING DOSE:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
ADMINISTRATION
- Application volume: 10 mL/kg bw
- Post dose observation period: 14 days

EXAMINATIONS
- Clinical observations were made several times on the day of dosing and at least once a day during the 14 day observation period. Body weights were recorded immediately prior to dosing and on days 7 and 14. Gross pathological examination was carried out on all animals.
Statistics:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: cut-off level according to OECD TG 423, Annex 2d
Mortality:
All 6 animals survived the treatment.
Clinical signs:
No clinical signs were observed.
Body weight:
Body weight development was not affected.
Gross pathology:
No gross pathological findings were observed.
Other findings:
No

NOEL: 2000 mg/kg bw

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Executive summary:

A single oral dose of 2000 mg/kg bw of the test item formulated in demineralized water and 2 % Cremophor EL was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD TG 423 the LD50 cut-off value of KGD 1409 is > 5000 mg/kg bw for rats (GHS Category 5 / unclassified).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A single oral dose of 2000 mg/kg bw of the test item formulated in demineralized water and 2 % Cremophor EL was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings (Schüngel, 2003). According to OECD TG 423 the LD50 cut-off value of KGD 1409 is > 5000 mg/kg bw for rats (GHS Category 5 / unclassified).

Justification for classification or non-classification

Based on the LD50 cut-off > 5000 mg/kg bw a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.