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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8th November to 26th November 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Well documented, OECD and GLP compliant 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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute 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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young, adult male and female New Zealand Albino Rabbits2, at least 12 weeks of age and weighing
between 2.32 – 2.72 kilograms were obtained from Kuiper Rabbitry, Gary, Indiana. The females were
nulliparous and nonpregnant. Rabbits were housed individually in stainless steel cages in a temperature
(63-73 °F), humidity (30-70%), and light controlled room. The rabbits were maintained according to the
recommendations contained in the National Academy Press 2011: "Guide for the Care and Use of
Laboratory Animals". Purina Rabbit Chow and water were available ad libitum. The rabbits were
acclimated at least 5 days prior to treatment. The rabbits were individually identified by an ear tag.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The neat test substance was adminstered by dermal application at a dose of 5000 mg/kgbw to five male and 5 female rabbits. All animals were weighed on the day of dosing. Based upon the animals weight the test substance was applied uniformly over approximatley 10 percent of the total body surface area, covered with two layers of porous gauze dressing and a sleeve of plastic sheeting was fitted over the shaved trunk of the animal and secured in place with non-irritating surgival tape. The test animals were then returned to their cages for the 24 hour contact period. The test substance remained in contact with the skin for a 24 hour period afte which time the wrap was removed and any remaining test susbtance wiped off.
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5/sex
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occured
Clinical signs:
other: No signs of clinical toxicity were observed
Gross pathology:
No gross changes observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The administration of test substance by dermal application at a dose of 5000 mg/kg body weight to male and female rabbits produced no mortality,
indicating that the dermal LD50 of the sample is greater than 5000 mg/kg body weight
Executive summary:

The test substance was tested for acute dermal toxicity according to OPPTS, OECD Guidelines. The test substance described as a brown liquid, was administered by dermal application at a dose of 5000 mg/kg body weight to five male and five female rabbits. No mortality occurred during the 14 day observation period. The acute dermal LD50 was found to be greater than 5000 mg/kg body weight. Based on GHS and OECD 402 guidelines, the test substance is not classified for acute dermal toxicity.