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Toxicological information

Acute Toxicity: oral

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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:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nossan - Correzzana (Milano)
- Age at study initiation: young adults
- Weight at study initiation: 200 +/- 20
- Fasting period before study: overnight
- Housing: transparent polycarbonate cages, 5 animals/cage
- Diet: pelleted complete diet
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 55 +/-15
- Air changes (per hr): min. 8
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

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: A careful clinical examination is made at frequent intervals during the first day and 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: Cageside observation include changes in the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomous and central nervous system, and somatomotor activity and behaviour pattern.

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:
POTENTIAL TARGET ORGANS: None identified
SEX-SPECIFIC DIFFERENCES: None.

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 Alchem 125 is >5000 mg/kg. This dose caused no adverse effects.