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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
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: contract laboratory protocol
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: COX-CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 216 to 253 grams

- Housing: Glass chamber for the duration of exposure to the test substance which after the animals were placed in individual wire-bottomed cages elevated above droppings.

- Diet: Purina laboratory Chow, pelletized (ad libitum)

- Water: ad libitum



IN-LIFE DATES: Not stated.

Administration / exposure

Route of administration:
other: mist
Type of inhalation exposure:
whole body
Vehicle:
other: atmosphere generated as a mist
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus: DeVilbiss Nebulizer

- Exposure chamber volume: 57 litres

- Method of holding animals in test chamber: shared glass chamber

- Source and rate of air: six litres per minute


TEST ATMOSPHERE

- Brief description of analytical method used: non specified

- Samples taken from breathing zone: not specified



CLASS METHOD (if applicable)

- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
71 mg/l
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed for gross effects at regular intervals on the day of exposure and daily thereafter for fourteen days. All animals were weighed at the beginning and end of the test period.
Statistics:
No statistical analysis performed.

Results and discussion

Preliminary study:
No preliminary study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 71 mg/L air
Exp. duration:
1 h
Mortality:
All rats survived the 1 hour exposure and subsequent 14 day  observation period.
Clinical signs:
other: During exposure, all animals displayed hypoactivity and/or ataxia, salivation and gasping. Generalised weakness was also evident when the animals were removed from the chamber at the end of the exposure. At the 24 hour observation period, all animals show
Body weight:
Final bodyweight records of the animals at termination (14 days) showed gains within expected limits, in all animals.
Gross pathology:
Gross necropsy of the animals at fourteen days showed slight to moderate pulmonary (all animals) and adrenal (two animals) congestion; otherwise findings were unremarkable.
Other findings:
The lungs were affected in all rats.

Any other information on results incl. tables

Table 1: Concentrations, exposure conditions and number of evident toxicity per animals treated.

Nominal

Conc. (mg/L)

Number with evident toxicity (#/total)

Males

Females

Combined

 71

 0/5

0/5

0/10

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The result was read across from 1-decanol. The rat 1 hour LC50 for Alfol 10 (mist) was >71 mg/l. Signs of intoxication during exposure included lethargy,and/or ataxia, salivation and gasping. Gross necropsy revealed congestion of the lungs in all animals.