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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
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: Study without detailed documentation for a read-across substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute IV study
GLP compliance:
no
Remarks:
pre-dates GLP
Limit test:
yes

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:
mouse
Strain:
ICR
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:
intravenous
Vehicle:
water
Details on exposure:
Administered to a groups of 10 mice by changing dose in accordance with the stage of administration.
Doses:
2.1, 3.0, 4.3, 6.0 g/kg body weight or 3.6, 5.0, 7.1, 10.0 ml/kg body weight for males and 3.0, 4.3, 6.0, 8.4 g/kg body weight or 5.0, 7.1, 10.0, 14.1 ml/kg body weight for females
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: general observation
Statistics:
Not required, acute study

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3.22 other: g/kg body weight
95% CL:
>= 2.53 - <= 3.66
Sex:
female
Dose descriptor:
LD50
Effect level:
5.6 other: g/kg body weight
95% CL:
>= 4.87 - <= 645
Mortality:
Females Death rate at 2 minutes: 0/10 at 3.0 g/kg body weight, 1/10 at 4.3 g/kg body weight, 7/10 at 6.0 g/kg body weight, 9/10 at 8.4 g/kg body weight
Male Death rate at 2 minutes: 1/10 at 2.1 g/kg body weight, 4/10 at 3.0 g/kg body weight, 9/10 at 4.3 g/kg body weight, 10/10 at 6.0 g/kg body weight
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
Not reported

Applicant's summary and conclusion