Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 403. GLP.
Justification for type of information:
See read-across justification provided in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
7500, 11250, 13125, 15000 and 18750 mg/kg of test substance.
No. of animals per sex per dose:
Four groups, each consisting of 5 male and 5 female Sprague-Dawley rats, and a fifth group containing 7 male and 6 female rats.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
14 063 mg/kg bw
Mortality:
Mortality rates, in ascending dose order, were 0%, 30%, 60%,40% and 90%.
Clinical signs:
Clinical signs included diarrhea and blood around the nose and mouth.
Gross pathology:
At necropsy, lungs showed effects ranging from mild irritation and congestion to fluid-filled abscesses. Intestines, and often the stomach, were found to be haemorrhaging. In some animals the heart was enlarged or irregular.

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 the test material is 14063 mg/kg. These findings do not warrant classification of the test article as an acute oral toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Executive summary:

Four groups, each consisting of 5 male and 5 female Sprague-Dawley rats, and a fifth group containing 7 male and 6 female rats were dosed with 7500, 11250, 13125, 15000 and 18750 mg/kg of test substance by oral gavage. The test animals were observed hourly for the first six hours after dosing and twice daily for fourteen days. Mortality rats of the five dose groups (7500, 11250, 13125, 15000 and 18750 mg/kg) were 0%, 31%, 60%, 40% and 90%, respectively. Clinical signs included diarrhea and blood around the nose and mouth. At necropsy, lungs showed effects ranging from mild irritation and congestion to fluid-filled abscesses. Intestines, and often the stomach, were found to be hemorrhaging. In some animals the heart was enlarged or irregular.

Based on the parameters of this study, the acute oral LD50 of the test material is 14063 mg/kg. These findings do not warrant classification of the test article as an acute oral toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).