C10-13-alkyl(branched, unsaturated)-succinic acid-4-(3-methyl-butyl)-ester

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-11-02 to 1999-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline and GLP conform well documented scientific study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Doses:

single dose: 2000 mg/kg bw (as a 20 % solution in Sesame oil)

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study period.

Clinical signs:

other: The following clinical signs were observed after the administration of Hostacor 4323: hypoactivity, squatting posture and bristling coat. Additionally, diarrhea was observed. From day 4 on until the end of the study no findings were observed.

Gross pathology:

No macroscopically changes visible.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of Hostacor 4323 for male and female rats is greater than 2000 mg/kg body weight.

Executive summary:

Acute oral toxicity testing of Hostacor 4323 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. After administration of a single dose of the test substance at 2000 mg/kg body weight in sesame oil as vehicle no mortality occurred. The animals showed hypoactivity, squatting posture and bristling coat. Additionally, diarrhea was observed. At day 4 of the study all clinical signs were reversible. Development of body weight was not impaired. All animals were killed at the end of the observation period. No macroscopically visible changes were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

To assess the acute oral toxicity a valid GLP compliant study is available which was performed in accordance to OECD 401.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the results obtained in this acute oral toxicity study the median lethal dose value (LD50) of Hostacor 4323 for male and female rats is greater than 2000 mg/kg body weight.

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).