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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:
16.09.1991 to 13.03.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: 5-7 wk
- Weight at study initiation: 136-228 g
- Fasting period before study: 17-18 hr
- Housing: 5/cage (separate sexes), polycarbonate cages
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
none

MAXIMUM DOSE VOLUME APPLIED: 2.23 ml/kg bw
Doses:
main study: 2007 mg/kg bw
preliminary study: 504, 1008, 2007 mg/kg bw
No. of animals per sex per dose:
main study: 5
preliminary study: 2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (changes to skin and fur, eyes, mucous membranes, respiratory system, circulatory system, autonomic and central nervous system, as well as somato-motor activity and behaviour. Shivering, convulsions, salivation, diarrhoea, lethargy, sleeping and coma were noted with particular attention.)
- Frequency of observations and weighing: deaths and abnormal clinical signs were noted 15 minutes after administration, then 1, 2 and 4 h then daily for 14 days; weighed on day before treatment (day -1), immediately prior to administration of the test substance (day 1), and on Days 8 and 15.
- Necropsy of survivors performed: yes, after the 14 day observation period (Day 15), with particular attention paid to the following organs: liver, heart, kidneys and lungs.
Statistics:
The body weights of the animals were evaluated for each sex. The mean, standard deviation and coefficient of variation were calculated. There were no deaths so an LD50 could not be calculated.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 007 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths at any dose.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 007 mg/kg bw
Based on:
test mat.
Mortality:
No deaths throughout the study.
Clinical signs:
Main study (2007 mg/kg bw)
Subdued behaviour in all treated animals at 1, 2 and 4 h, no overt clinical effects at Day 2.
Body weight:
No effect.
Gross pathology:
No remarkable macroscopic findings.

Any other information on results incl. tables

Table 1: Number of animals dead

 

Dose
(mg/kg bw)

Mortality (dead/total)

Male

Female

Combined

504a

0/2

0/2

0/4

1008a

0/2

0/2

0/4

2007a

0/2

0/2

0/4

2007b

0/5

0/5

0/10

a. preliminary study

b. main study

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In an acute oral limit test, conducted in compliance with the now deleted OECD 401 and in accordance with GLP (reliability score 1), there was no mortality or marked systemic effect in rats at 2007 mg/kg bw.