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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1954
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
publication
Title:
RANGE FINDING TOXICITY DATA PT. V (5)
Author:
Smyth HF, Carpenter CP, Weil CS & Pozzani UC
Year:
1954
Bibliographic source:
AMA Arch Ind Hyg Occup Med (1954) 10(1):61-68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
- Reliability scoring based on 2009 guideline
Deviations:
yes
Remarks:
-housing and diet information, strain, time of death, body weight and necropsy findings not reported; exposure period was not 7 hr; concentration not verified; < 10 animals tested
GLP compliance:
no
Remarks:
Study pre-dates GLP
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
male
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.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: no data
Details on inhalation exposure:
Inhalation of known vapor concentrations by rats is conducted with flowing streams of vapors prepared by various styles of proportioning methods. Exposures are 4 hours long. Concentrations are in an essentially logarithmic series with a factor of two, and data for the concentration yielding fractional mortality among six rats within 14 days are presented. Where no fractional mortality was observed, both the concentration yielding no mortality and that yielding complete mortality are indicated.
Analytical verification of test atmosphere concentrations:
no
Remarks:
Nominal concentrations are recorded, not confirmed by analytical methods.
Duration of exposure:
4 h
Concentrations:
16000 ppm
No. of animals per sex per dose:
6 males in total
Control animals:
not specified
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.
Statistics:
Not required for acute studies.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: Mortality in 14 days following exposure
Effect level:
16 000 ppm
Exp. duration:
4 h
Mortality:
5/6 animals died within 14-day observation period.
Clinical signs:
other: Not reported.
Body weight:
Not reported.
Gross pathology:
Not reported.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
other: unable to classify with the data presented
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.