Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1111

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 1981
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Tradename Lial 111 Type A

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Nossan-Correzzana, Milan, Italy

- Weight at study initiation: 200g (+- 20 g)

- Fasting period before study: fasted
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:



ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Doses:
5000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations made at frequent intervals on the day  of dosing then daily. Body weights were recorded at the end  of the observation period and compared to controls.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived to the end of the 14 day observation  period.
Clinical signs:
None observed. 
Body weight:
There were no adverse effects on  bodyweight.
Gross pathology:
None reported.
Other findings:
No target organs identified, no sex-specific differences detected.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat oral LD50 for Lial 111 is >5000 mg/kg. There were no signs of toxicity.