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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
This study was designed to comply with the standards set forth in 49 CFR 173.132(b)(2)
GLP compliance:
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
Test material form:
solid: particulate/powder
Details on test material:
Lot no: 4500566148-0003

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
Animals were received on 25 Jan 2012. Following an acclimation period of at least one week, three healthy male and three healthy, non-pregnant and nulliparous female New Zealand White rabbits were assigned to the treatment group without conscious bias.

The animals were born on 13 Aug 2011 & 20 Aug 2011. The pretest body weight range was 2.8 - 3.1 kg for males and 2.6 - 3.1 kg for females. The animals were identified by cage notation and a uniquely numbered metal eartag and individually housed in suspended stainless wire bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Type of coverage:
Details on dermal exposure:
Prior to application of the test article, the dorsal trunk of the animal was clipped. The area began at the shoulders and extended to the hip bone and half way down the flank of each side of the animal.

A single dose of the test article was moistened with 2.5 ml of distilled water to form a paste and applied to the prepared site under a 10 x 15 cm porous gauze patch at a dose level of 1000 mg/kg. The dose was based on the dry weight of the test article. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The torso was covered with a piece of porous dressing (semi-occlusive) large enough to cover the dose site with at least 5 cm square to spare on all sides of the gauze patch. Porous, non-irritating tape was used to encircle the trunk of the animal. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed.
Residual test article was removed by gently washing with distilled water.
Duration of exposure:
24 hours
1000 mg/kg
No. of animals per sex per dose:
3 male/3 female

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
All six rabbits survived the 1000 mg/kg dermal application.
Clinical signs:
other: Erythema and edema were absent at 24 hour postdose, Day 7 and at study termination. No abnormal physical signs were observed.
Gross pathology:
The gross necropsies of all animals revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The LD50 of Compound 3017431, Lot# 4500566148-0003 is greater than 1000 mg/kg of
body weight in rabbits. The test article is not a poisonous material as defined in 49 CFR 173.132
(a)(1)(ii). The GHS Classification is Not classified.
Executive summary:

Three healthy male and three healthy female New Zealand White rabbits were
dosed dermally with Compound 3017431, Lot# 4500566148-0003 at 1000 mg/kg of body weight. The
test article was kept in contact with the skin for 24 hours. Dermal responses were recorded 24 hours postdose and on Days 7 and 14. Animals were observed for mortality, toxicity and pharmacological effects at 1 and 2 hours postdose and once daily for 14 days. Body weights were recorded pretest, Day 7 and at termination. All animals were examined for gross pathology. All six rabbits survived the 1000 mg/kg dermal application.
No abnormal physical signs were observed. Erythema and edema were absent at 24 hour postdose, Day 7 and at study termination. Four out of six animals experienced body weight gain by Day 14; one female and one male animal's
weight remained the same. The gross necropsies of all animals revealed no observable abnormalities.