3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

Acute Toxicity: dermal

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

Test material information

Constituent 1

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.