Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1948
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
publication
Title:
FURTHER EXPERIENCE WITH THE RANGE FINDING TEST IN THE INDUSTRIAL TOXICOLOGY LABORATORY
Author:
Smyth HF & Carpenter CP
Year:
1948
Bibliographic source:
J Ind Hyg Toxicol 30(1):63-68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
reliability scoring based on 2001 guideline for Test No. 423
Deviations:
yes
Remarks:
Lacking detail in methodology and results
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements
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): Isopropanol

Test animals

Species:
rat
Strain:
Sherman
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- 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:
acetone
Details on oral exposure:
No information provided
Doses:
Not reported. The authors state rats are given dosages differeing in a ratio of 10.
No. of animals per sex per dose:
6 rats/dose group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days (or other?); Not reported
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Not reported
Statistics:
Not reported

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5.84 other: g/kg body weight
Mortality:
Not reported
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)
Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.