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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Restrictions: no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
traditional method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexanol
EC Number:
203-630-6
EC Name:
Cyclohexanol
Cas Number:
108-93-0
Molecular formula:
C6H12O
IUPAC Name:
cyclohexanol
Test material form:
not specified
Details on test material:
Supplier: BASF
Highest purity, purity not specified.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: MUS RATTUS Brunnthal
- average weight at study initiation: 178g (male), 176 g (female)
- Feeding: Herilan MRH der Firma H. ECGERSMANN, Rinteln/Weser; ad libitum
- Water: tap water; ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
Aerosol was generated using "Dauerinfusionspumpe" UNITA (B, Braun), and "Zweistoffdüse" (Rhema)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
method: gas chromatography
Duration of exposure:
4 h
Concentrations:
Nominal/target concentration: 7.5 mg/L
Analytical concentration: 3.63 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14d
- Control animals: air
- Frequency of observations : daily
- Frequency of weighing: before begin, on day 7 and at termination
- Necropsy of survivors performed: yes
Statistics:
A modification of the Wittig Binomial test (Wittig H: Matematische Statistik 1974, S 32-35)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 3.6 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
no deaths occured
Clinical signs:
other: Ruffled fur coat was noticed after exposure. Symptoms dissappeared after 1 day.
Body weight:
TREATED ANIMALS
- In comparison to the air controls, body weight gain was not influenced. Mean body weight on day 7 was 221g (male) and 198g (female). On day 14, body weights were 250 g (male), and 209g (females). CONTROLS: Day 0: 180g (male); 173g (female)
Day 7: 224 g (male); 194 (female)
Day 14: 261g (male); 207g (female)
Gross pathology:
No adverse gross pathological findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LC50 under the conditions of the test was >3.6 mg/L leading to a classification into class Acute Tox. 4.
Executive summary:

This acute inhalation toxicity test was performed similar to OECD Guideline 403. GLP compliance was not reported. A group of 20 Sprague-Dawley rats (10 male and 10 female) was subjected to a nominal vapour concentrated airstream of the test material for four hours. Animals were observed for 14 days. No mortalities were observed. Clinical signs included ruffled fur coat, which disappeared after one day. No abnormalities were detected in the organs of survivors. Under the conditions of the study the LC50 for rats was reported to be >3.6 mg/L.