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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:
23 December 1982 to 12 January 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
See principles of method if other than guideline
Principles of method if other than guideline:
Deviations from the Protocol:
The proposed dates of completion and submission of the report had to be postponed because of the further administration of additional doses of the test material
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SFF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 180-218 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 3 with standardised soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: provided ad libitum.
- Water: Water was provided ad libitum.
- Acclimation period: nda

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: approximately 15 air changes/h.
- Photoperiod: 12 hours light/day

- The rat has been selected for this test as being a standard species for the determination of an acute oral LD50.
- Animal ID: by colour code using picric acid.
- The animals were allocated to the different dose groups by random selection.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
nda
Doses:
50, 100, 150, 225, 350 mg/kg
No. of animals per sex per dose:
5 males and 5 females (50 in total)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer.
- Frequency of observations: Daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
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 LD50 including the 95 % confidence limit were computed by the logit method.

Results and discussion

Preliminary study:
n/a
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
101 mg/kg bw
Based on:
test mat.
95% CL:
>= 51 - <= 137
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
101 mg/kg bw
Based on:
test mat.
95% CL:
>= 37 - <= 153
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
113 mg/kg bw
Based on:
test mat.
95% CL:
>= 24 - <= 189
Mortality:
See Table 1.
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur and curved body position are symptoms commonly seen during the observation time following administration of substances by,gavage.
In addition, the test material induced the following symptoms:
- diarrhoea, which duration increased with the dose level.
- salivation in the highest dose group during the first few hours after administration of the test material.
- sedation in all dose groups, increasing with the dose level.

Behaviour:
- Special attention was paid to the behaviour of the rats, particularly to their possible agressivity.
- no obvious agressivity, no injuries during life, no cannibalism could be seen during the observation period.

See Table 3.
Body weight:
See Table 2.
Gross pathology:
At necropsy, dilatation of parts of the digestive tract (small intestine, large intestine) was found by most of the mortally intoxicated rats in the four higher dose groups. This was not observed by the animals which recovered before terminal sacrifice.
Other findings:
nda

Any other information on results incl. tables

The 17 animals recovered within 13 days.

According to the Company Standard the test material has a medium acute toxicity when administered orally to the albino rat.

Applicant's summary and conclusion

Interpretation of results:
other: EU Criteria: Category 3, Toxic if swallowed
Conclusions:
Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50's were determined for the test material: Male rats - 101 mg/kg bw, Female rats - 113 mg/kg bw and Both sexes - 101 mg/kg bw.
Executive summary:

In an acute oral study in the rat the LD50's for the test material were determined to be 101, 113 & 101 mg/kg bw for males, females and both sexes respectively. According to EU interpretation this test material is classed a toxic.

The symptoms observed include Dyspnoea, exophthalmus, ruffled fur and curved body position. Other symptoms ovserved include diarrhoea, salivation and sedation.

At necropsy, dilatation of parts of the digestive tract (small intestine, large intestine) was found by most of the mortally intoxicated rats in the four higher dose groups. This was not observed by the animals which recovered before terminal sacrifice.