Mixed LOF

Acute Toxicity: inhalation

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

Test material information

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.