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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD TG 403 performed under GLP conditions on an analogue substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Naphtha (petroleum), light catalytic cracked
EC Number:
265-056-2
EC Name:
Naphtha (petroleum), light catalytic cracked
Cas Number:
64741-55-5
IUPAC Name:
Naphtha (petroleum), light catalytic cracked
Constituent 2
Reference substance name:
light catalytically cracked naphtha
IUPAC Name:
light catalytically cracked naphtha

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: no vehicle
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Scott Model 216 Hydrocarbon Analyzer
Duration of exposure:
ca. 4 h
Concentrations:
nominal: 5000 mg/m³
analytical: 5250 mg/m³
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 250 mg/m³ air (analytical)
Exp. duration:
4 h
Mortality:
No animals died during the course of the exposure or the subsequent 14-day observation period.
Clinical signs:
other: No treatment-related effects.
Body weight:
No treatment-related effects.
Gross pathology:
No treatment-related effects.

Any other information on results incl. tables

The study report reported in units of mg/L. Conversions assumption was 1 mg/L = 1000 mg/m³.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the conditions of this study, the LC50 for acute inhalation exposure to API 81-04 is > 5250 mg/m³. This finding does not warrant classification of API 81-04 vapor as an acute inhalation toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

API 81-04 was administered via individual inhalation chambers for four hours to ten Sprague-Dawley rats at the analytical vapor concentration of 5250mg/m³ to assess acute inhalation toxicity. Animals were observed for fourteen days following exposure. There were no mortalities and no other treatment-related effects. No gross abnormalities were observed at necropsy. Based on the conditions of this study, the LC50 for acute inhalation exposure to API 81-04 is > 5250mg/m³. This finding does not warrant classification of API 81-04 vapor as an acute inhalation toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

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