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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:
Not specified
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study appears to follow to OECD guideline 403. However it is not GLP (GLP was not mandatory when study was done). There is no information on the purity of test, the source and age of the animals, the period of acclimation, on housing and environmental conditions and how often the clinical signs and mortality were checked. No analytical method was used to monitor the concentration of test material in the chamber and it is not known if equilibration was reached. There is no information on exposure data and the dose level that the animals were exposed to.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
No information on the purity of test, the source and age of the animals, on housing and environmental conditions, how often the clinical signs and mortality were checked, no analytical method used, no information on exposure data and the dose level used.
GLP compliance:
no
Remarks:
[not mandatory at the time of the study]
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): NIAX Catalyst C-210
- Physical state: Liquid
- Analytical purity: As supplied

Test animals

Species:
rat
Strain:
other: Hilltop-Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Diet (e.g. ad libitum): ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The vapour is produced by passing air (at 2.5 liters/min) through the sample and then through a 9-liter animal chamber (dynam ic conditions). Oxygen is added, as neededm for static exposures to maitain a chamber oxygen constant of approximately 20%.
- Exposure chamber volume: 9 liter
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 6 h
Concentrations:
Not specified but only one concentration
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: Weighing was carried out 7 and 14 days after exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology
Statistics:
Not applicable

Results and discussion

Preliminary study:
No deaths occurred during the course of the study.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Exposure level unknown
Sex:
female
Dose descriptor:
LC50
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Exposure level unknown
Mortality:
No mortality occurred during the course of the study in any of the animals
Clinical signs:
No clinical signs were noted
Body weight:
All animals gained weight during the course of the study.
Gross pathology:
Gross pathology did not find anything remarkable.
Other findings:
Not applicable

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the absence of death, no classification is proposed for acute inhalation toxicity
Executive summary:

Group of 5 male and 5 female Hilltop Wistar rats were exposed to saturated vapours of the test substance for 6 hours. No mortality (0/5 males and 0/5 females died) was observed. All animals gained weight during the course of the study. There were no clinical signs and nothing was reported at necropsy. It was not possible to derive the LC50 since the exposure level is not reported in the study. However, in the absence of mortality and clinical signs it is considered that the substance is to be considered as non-toxic for acute inhalation toxicity.