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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation for a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
purity, source and physio-chemical properties of substance not reported; animal housing information not reported.
GLP compliance:
no
Remarks:
pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sorbitol
- Physical state: solid (powder)
- Analytical purity: not reported (60% w/v solution with distilled water)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: 5 weeks
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported


IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
-Quantity of solution: 56.6, 40.0, 28.3, or 20.0 ml/kg
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): Not reported
- Justification for choice of vehicle: Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported


MAXIMUM DOSE VOLUME APPLIED: Not reported.


CLASSIC METHOD
- Rationale for the selection of the starting dose: Not reported
Doses:
12, 17, 24, 34 g/kg or 20, 28.3, 40.0, 56.6 ml/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported
- Other examinations performed: Not reported
Statistics:
Acute study, not required

Results and discussion

Preliminary study:
Not reported
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
20.2 other: g/kg
95% CL:
>= 18.4 - <= 22.2
Sex:
female
Dose descriptor:
LD50
Effect level:
18.9 other: g/kg
95% CL:
>= 16.3 - <= 21.7
Mortality:
Male death rate at 1 day: 10/10 at 34.0 g/kg, 9/10 at 24.0 g/kg, 1/10 at 17.0 g/kg 0/10 at 12.0 g/kg
Female death rate at 1 day: 10/10 at 34.0 g/kg, 8/10 at 24.0 g/kg, 4/10 at 17.0 g/kg, 0/10 at 12.0 g/kg
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
Not reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP EC 1272/2008