Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7th November to 22nd November 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
EC Number:
701-350-3
Molecular formula:
Not possible to assign, UVCB
IUPAC Name:
3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
Test material form:
liquid
Details on test material:
- Appearance: brown liquid
- Storage: room temperature, in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young, adult male and female Sprague-Dawley rats 10 weeks and weighing between 226-268 grams were obtained from Envigo RMS, Indianna. The females were nulliparous and nonpregnant. The rats were housed individually in stainless steel cages in a temperature , humidity and light controlled (12 hour/cycle) room. Each animal was assigned a test animal number which appeared on a cage card visible on the front of each cage. The rats were maintained according to the recommendations contained in teh National Academy Pres. Purina Laboratory Rat Chow and were were available ad libitum. The rats were acclimated at least five days prior to treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
3/sex
Control animals:
no
Details on study design:
A 2000 mg/kg body weight limit test will be conducted. A limit test at one dose level of
2000 mg/kg body weight will be conducted on six rats (three rats per sex). If significant test
substance mortality is produced, further testing at the next dose level may be carried out. The
additional testing will be conducted starting at an appropriate dose levels (usually 300 mg/kg) to
determine the LD50. If greater than 50% of the rats survive at 2000 mg/kg, the LD50 will be
considered greater than the limit dose and the study will be terminated (i.e. carried out to 14 days
observation without dosing further rats).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed
Clinical signs:
other: No clinical signs of toxity observed
Gross pathology:
no gross changes observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 was determined to be greater than 2000 mg/kg body weight. Based on GHS and OECD 423 guidelines, as there were no deaths in the 6 rats tested the LD50 > 2000 mg/kg, and the substance does not need to be classified for acute oral toxicity.
Executive summary:

The test substance was administered by oral gavage at a 2000 mg/kg body weight limit dose level, according to the Acute

Toxic Class Method to male and female rats. The acute oral LD50 was determined to be greater than 2000 mg/kg body weight. Based on GHS and OECD 423 guidelines, as there were no deaths in the 6 rats tested, the LD50 > 2000 mg/kg, and the substance does not need to be classified for acute oral toxicity.