Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/07/2015-06/08/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Identification: Maderal ZA1076, code number: PH15/0488
Date of received: 08/07/2015
Container: glass flask (x1)
Quantity: 118.10 g (container + content)
Batch: 100026324
Production date: 11/03/2015
Form: liquide
Colour: colourless
Storage: room temperature / darkness
Expiry date: 10/03/2016

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
SPF Caw
Sex:
female
Details on test animals and environmental conditions:
Animals:
Source: Elevage JANVIER LABS
Acclimatation: at least 5 days
Age at the beginning of the study: 8 weeks
Identified prior to inclusion by numbered rings on the edge of one ear

Housing:
By group of three female in solid-bottomed clear polycarbonates cages with a stainless steel mesh lid.
Bedding: Sawdust changed at least 2 times a week.
Air: Conventional air conditioned animal husbandry
T°: 19-25°C
Relative Humidity: 30-70%
Rate of air exchange: 10 changes per hour
Photoperiod: 12h light (07.00-19.00) /12h darkness

Food and drink:
Drinking water: tap-water from public distribution system, analysed (chemical and microbiological) every 6 months by Eurofins IPL - Atlanique (Bordeaux)
Foodstuff: A04, supplied by SAFE
Both were supplied freely

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Gavage under a volume of 2.11 mL/kg (~2 g/kg), using a suitable syringe graduated fitted with an oesophageal metal canula
Doses:
2000 mg/kg body weight of the test item
No. of animals per sex per dose:
6
Control animals:
yes
Remarks:
3 female rats, received the control item distrilled water by gavage under a volume of 10 mL/kg body weight using a suitable syringe fitted with an oesophageal metal canula
Details on study design:
Daily examination: identify behavioural / toxic effect on the major physiological functions during 14 days following the administration of the test item
Weight examination: On D0 (before administering the test item) ; D2 ; D7 ; D14
End of the test examination: On D14, animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were noted. Only organs likely to be modified in case of acute toxicity were examined. No organ was removed and preserved in view to microscopic examination
Statistics:
Not specified

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study
Clinical signs:
No clinical signs related to the administration of the test item were observed
Body weight:
The body weight evolution of the animals remained normal during the study
Gross pathology:
Macroscopic examnation at the end of the study did not reveal treatment related changes

Any other information on results incl. tables

Deviations:

Relative humidity > 70% was registered on 05/08/2015. Maximum value recorded : 71%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral toxicity was performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

The results are the following:

LD50 > 2000 mg/kg body weight by oral route in the rat

LD50 cut-off of the test item may be considered > 5000 mg/kg body weight by oral route in the rat