Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth H, Carpenter C, Weil C, Pozzani U, & Striegel J
Year:
1962
Bibliographic source:
AMER-IND-HYG-ASSN-J. 23. 95-107, 1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Missing information on test material, test animals, housing conditions, diet, environmental conditions, dermal exposure, vehicle, doses, examinations and measurements. No individual results were reported
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements
Test type:
other: Similar to the cuff method of Draize et al.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-butanone

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 2.5 to 3.5 kg
- 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:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: entire trunk
- % coverage: Not reported
- Type of wrap if used: Plastic film


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Constant volume or concentration used: yes
- For solids, paste formed: Not reported


VEHICLE
No information
Duration of exposure:
24 hours
Doses:
Not specifically reported. It is reported that, dosages greater than 20 ml/kg can not be retained in contact with the skin.
No. of animals per sex per dose:
4 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- 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:
LD50 was reported to be calculated

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Mortality:
Not reported
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
Not reported

Any other information on results incl. tables

No tables or results presented

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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.