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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See justification attached to IUCLID chapter 13.
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20°C. Young adult laboratory rats, 6 per sex, were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
no
Specific details on test material used for the study:
Name of test material (as cited in study report): Tri-Decanol, Mixture of branched primary alcohol
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Diet: ad libitum
- Water: ad libitum
Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: No source mentioned; 200 L/h

TEST ATMOSPHERE
- Brief description of analytical method used: no analytics performed
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
No verification of the concentration was performed. Nominal concentration: 0.3 mg/l (determined by means of re-weighing)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: group wise documentation on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 0.3 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: IRT: the calculated nominal test atmosphere has to be considered as saturated at 20°C
Mortality:
There was no mortality after 8 h exposure of a saturated atmosphere.
Clinical signs:
other: No clinical findings were noted.
Body weight:
No data
Gross pathology:
No gross pathological findings were noted.
Interpretation of results:
GHS criteria not met

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 0.3 mg/L air
Exp. duration:
8 h
Remarks on result:
other: as determined from read-across, CAS 27458-92-0

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification