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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:
2018-06-25 to 2018-07-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
Version / remarks:
2009
Deviations:
yes
Remarks:
It proved impossible to generate a suitable vapour atmosphere of the test item which would be in compliance with the test guideline. This was considered not to have affected the validity of the study.
Qualifier:
according to
Guideline:
EU Method B.52 (Acute Inhalation Toxicity - Acute Toxic Class Method)
Version / remarks:
2014
Deviations:
yes
Remarks:
It proved impossible to generate a suitable vapour atmosphere of the test item which would be in compliance with the test guideline. This was considered not to have affected the validity of the study.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Results and discussion

Any other information on results incl. tables

The mean non-volatile component of the test item was found to be 70.88% (n=10).

The test item vapor was generated and the following results were achieved in terms of atmosphere concentrations: 

Duration of Exposure (minutes)

Flow (L/min)

Volume of Air Sampled (L)

Atmosphere Concentration (mg/L)

Air

Exhaust

13

5

50

10

0.0059

30

10

50

2

0.1199

42

15

50

1

0.2219

53

20

50

1

0.2827

 

Although it was possible to generate a vapor atmosphere of the test item, the concentrations achieved were much lower than those required by the test guidelines (0.5 to 20 mg/L).  It was considered, that generation of the test item as an aerosol would not be appropriate due to the nature of the test item.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In view of the physical nature of the test item it is considered unlikely to represent a significant hazard by the inhalation route.