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Administrative data

Description of key information

The LD50 value of the test item was above 5000 mg/kg bw, the highest concentration tested (CIBA-GEIGY, Ltd., 1984).

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:
May 16,1984 - May 30, 1984; Report June 12, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
This test has been put under QA surveillance by the QAU
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
Number of Animals Per Dose Level: 5 males and 5 females
Total Number of Animals: 10

Source:
CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland

Initial Body Weight Range :
164-229 g

Initial Age:
7-8 weeks

Individual Identification:
by colour code using picric acid

Husbandry:
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin) . The animal room was air conditionned: temperature 22+3° C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.

Diet:
Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Administration: oral, by gastric intubation (gavage)
Vehicle: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Dose Level: 5000 mg/kg bw.
Volume (ml/kg body weight) applied: 20
Administration of the Test Article: one single dose, per os

The animals were allocated to the different dose groups by random selection.
Prior to dosing, the animals were fasted overnight.
Doses:
Dose Level: 5000 mg/kg bw.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days

Mortality: daily; a.m. and p.m. on working uays, a.m. on weekend days
Signs and Symptoms: daily
Body weight: on days 1, 7, 14 and at death
Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LDSO including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at a concentration of 5000 mg/kg bw.
Clinical signs:
Dyspnoea, exophthalmus, ruftled fur, and curved body position were seen.
The surviving animals recovered within 10 days.
Body weight:
During the observation period the test item revealed no effects neither on male nor female animals.
In the dose level of 5000 mg/kg the mean bodyweight (standarddeviation) of male animals increased from 208 (19.2) on day 1 and 253 (21.9) on day 7 up to 301 (27.4) g on day 14. For female animals the bodyweight increased from 179(10.9) on day 1 and 200 (17.9) on day 7 up to 212 (13.4) g on day 14, respectively.
Gross pathology:
No gross lesions were found at necropsy.
Conclusions:
The test item has practically no acute toxicity when administered orally to the albino rat. LD 50 > 5000 mg/kg/bw
Executive summary:

In an acute toxicitystudy according to OECD Guideline No. 401, 5 male and 5 female albino rats were exposed to 5000 mg/kg/bw after oral administration.

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined for the test item.

LD50 in male rats; >5000 mg/kg bw.

LD50 in female rats; >5000 mg/kg bw

LD5O in rats of both sexes; > 5000 mg/kg bw

The test item has practically no acute toxicity when administered orally to the albino rat.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The study was conducted following an accepted guideline with acceptable restrictions (Klimisch 2).

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

Justification for classification or non-classification

Based on the results of the acute oral study and according to the criteria of EC Regulation 1272/2008 the test item has practically no acute toxicity if swallowed (LD50 (rat) > 5000 mg/kg bw). Therefore, the test substance must not be classified.