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Administrative data

Description of key information

The LD50 of the test substance was greater than 2000 mg/kg bw in an acute oral toxicity study in rats.

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:
2014-03-17 to 2014-04-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to GLP and OECD guidelines
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 10 weeks
- Weight at study initiation: 177 - 189 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 %
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle: 10 mL/ kg bw
- Justification for choice of vehicle: A good homogeneity in water could not be guaranteed, because the test item preparation was a suspension. Therefore a 0.5 % solution of CMC in deionized water was applicable.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: requested by the sponsor, no acute toxiicty expected up to 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed during clinical examination.
Body weight:
The mean body weight increased within the normal range throughout the study period, but the individual weights of two females slightly increased or stagnated in the second week.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP and OECD Guideline study

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

Oral

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the test item (preparations in 0.5% CMC-solution in deionized water) were administered by gavage to two test groups of three fasted Wistar rats each. During the 14-days observation period, no mortality occured and no clinical signs were observed. There were no macroscopic pathological findings at the end of the observation period. On the basis of these results, the acute oral LD50 was determined to be greater than 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.