Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 EXPERINCE 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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Lack of methodological details
GLP compliance:
no
Remarks:
study pre-dates GLP requirements
Test type:
other: Not reported
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:
rabbit
Strain:
not specified
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

Type of coverage:
other: rubber cuff
Vehicle:
other: carbitol
Details on dermal exposure:
TEST SITE
- Area of exposure: Not reported
- % coverage: Not reported
- Type of wrap if used: rubber cuff


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure:Not reported


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported, the authors stated that dosages as great as 20 ml/kg can be retained by the cuff.



VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
Duration of exposure:
24 hours
Doses:
Not reported, the authors stated that dosages as great as 20 ml/kg can be retained by the cuff.
No. of animals per sex per dose:
It is reported that the number of animals used are similar to those given oral dosages. The oral LD50 section reports groups of 6 rats.
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:
16.4 mL/kg bw
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.