Mixed LOF

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 performed under GLP conditions on an analogue substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Method: other: API procedure (see Reference).

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:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 male and 5 female/dose

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No deaths resulted.

Clinical signs:

other: Clinical signs noted in the study were hypoactivity, ataxia and diarrhea.

Gross pathology:

No visible lesions were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the parameters of this study, the acute oral LD50 of API 81-03 is greater than 5000 mg/kg. These findings do not warrant classification of the test article as an acute oral 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:

Five male and five female SD rats were given a dosage of 5000 mg/kg test article API 81-03 by oral gavage. The test animals were observed hourly for the first six hours after dosing and twice daily for fourteen days. No animals died during the study period. Clinical signs observed were diarrhea, ataxia, and hypoactivity. At necropsy, no visible lesions were observed. Based on the parameters of this study, the acute oral LD50 of the test material is greater than 5000 mg/kg. These findings do not warrant classification of the test article as an acute oral 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.