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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
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
granulate
Specific details on test material used for the study:
FAT 41001/D

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation:7-8 weeks
- Weight at study initiation: 178-219 g
- Housing: 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 (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%):55+-15
- Air changes (per hr):approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 and 200 mg/mL
- Amount of vehicle (if gavage): 20 and 10 mL/kg bw
- Dose levels: 5000, 2000 mg/kg bw.

MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg bw
Doses:
5000, 2000 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
- Frequency of clinical observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, signs and symptoms, body weight, necropsies
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured at 2000 mg/kg bw, besides one male rat, which died due to intratracheal intubation.
At 5000 mg/kg bw all male and 3 female rats died on Day1. The remaining two female rats died on Day 2.
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, diarrhea was noted during the first two days as well as a blue staining of the eyes and extremities.
The surviving animals recovered within 10 days.
Body weight:
No significant changes were observed in surviving rats
Gross pathology:
In the high dose group all animals had a blue stained carcass. No other findings were made at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value in rats via oral administration of test substance was found to lie between 2000 and 5000 mg/kg bw.
Executive summary:

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

LD50 in rats of both sexes is between 2000 and 5000 mg/kg bw

According to the company standard the test substance has a slight acute toxicity when administered orally to the albino rat.