(2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

(2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride

Cas Number:

2171323-89-8

Molecular formula:

C18H20CIF2NO2

IUPAC Name:

(2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride

Specific details on test material used for the study:

Substance name: X12485647
Lot #: SS17000602-2 (TSN402954)
Purity: 98%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

reverse osmosis

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

03 females

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no incidents of mortality

Clinical signs:

other: There were no clinical abnormalities, and no signs of skin irritation.

Gross pathology:

No external or internal gross abnormality was observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50 (Rat, female): >2000 mg/kg

Executive summary:

In an acute dermal toxicity study, three female Wistar rats (approximately 13-15 weeks old and weighing 206.8-231.4 g at dosing) were dermally exposed to the test substance for 24 hours at 2000 mg/kg body weight. The required amount (413.6 to 462.8 mg) of the test substance (moistened with 0.5 mL RO water) was applied over the treatment area (approximately 7 cm × 5 cm body surface area, previously clipped), and held in contact with skin using porous gauze dressing and a non-irritating tape (semi-occlusive) throughout 24-hour exposure period. Initially, only one rat was treated. Based on the observations at 24-hour post patch removal, two additional rats were dosed sequentially. At the end of the 24-hour exposure period, the residual test item was removed from the application site with a piece of cotton, soaked in RO water. Skin reactions of each rat were observed at 24, 48, and 72 hours post patch removal. Rats were observed for a period of 14 days (in which mortality, clinical signs, and body weights were recorded), after which they were sacrificed and subjected to gross necropsy examination.

No mortality or clinical signs were observed in any rat, throughout the study period.

No erythema or oedema was evident in any rat at 24, 48, and 72 hours, post patch removal.

All rats treated with the test substance at 2000 mg/kg body weight showed no effect on their body weights. All rats gained weight during the study.

No external or internal gross abnormality was observed at necropsy.

Based on the study results, the acute dermal median lethal dose (LD50 value) of the test substance in female Wistar rats was found to be greater than 2000 mg/kg body weight.

Based on the results of this study, the GHS classification of the test substance for acute dermal toxicity is as follows: Globally Harmonized System of Classification and Labelling of Chemicals: Unclassified