Registration Dossier

Administrative data

Description of key information

The test substance is non toxic after single oral exposure (LD50, rat: > 2000 mg/kg bw).

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:
April 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Hsd Cpb: WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: no data
- Mean weight at study initiation: 192 g - 224 g (males) or 169 g - 190 g (females)
- Housing: in groups of 5 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
other: 0.5% (v:v) aqueous tylose
Details on oral exposure:
- Application volume: 20 mL/kg bw

Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day odf administration and subsequently at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes
Statistics:
none (limit test)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died after administration of 2000 mg/kg bw.
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:
none
Executive summary:

In the acute toxicity study performed 1996 according to OECD TG 423 the test substance was untoxic with a LD50 value > 2000 mg/kg bw in rats. The oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain or gross pathological findings in both sexes.

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

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

In the acute toxicity study performed 1996 according to OECD TG 423 the test substance was untoxic with a LD50 value > 2000 mg/kg bw in rats.The oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain or gross pathological findings in both sexes.


Justification for selection of acute toxicity – oral endpoint
There are identical LD50 values for mouse and rat available. The rat study was selected because the preferred test species for evaluation of acute toxicity by the oral route is the rat.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.