Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th to 28th april 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Oral acute toxicity according to OECD 401

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
White powder
Specific details on test material used for the study:
1574 acide crist batch 2/88 R SI

Test animals

Species:
rat
Strain:
other: ICO (OFA-SD - IOPS caw)
Sex:
male/female
Details on test animals and environmental conditions:
During acclimatation period :
Temp = 22°C +/- 3°C
Hygrometry : 50 +/- 20%
12 hours day light / 12 hours dark
Non recycled filtered air

5 animals of the same sex per box

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
Substance administrated by suspension to animals
One administration by means of oesophagic pipe
Doses:
DOse : 2000mg/kg in a volume of 10ml/kg.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Observation once per day until the 14th day to notice clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1 male after 1 hour - 1 female after 4 hours and on male and one female after 24 hours
Clinical signs:
Hypokinesy after 15min the sedation
lateral decubitus after 30 minutes and piloerection after 46 hours.
After 24h less symptoms and normal behaviour of all survivors at day 6
Body weight:
Weight evolution slow between days 1 and 5 then, normal growth from day 8 to day 15

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under experimental conditions LD50 (oral route- Rat) of the substance 1574 acide is > 2000mg/kg. At this dose mortality is 40%
Executive summary:

Under experimental conditions LD50 (oral route- Rat) of the substance 1574 acide is > 2000mg/kg. At this dose mortality is 40%