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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch # ZD48725 Lot 002 (Dispensary number 0683/02-1340)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species, Strain and Supplier: New Zealand White Rabbits of the Cr;L NZW/Kbl.BR strain were obtained from the Charles River UK Ltd, Margate on 2 and 9 July 2002. The animals were examined annd weighed on the day day of arrival. The rabbitw were in a body weight range of 2.19 to 2.80 kg on the day before dosing. Based on information from the supplier the rabbits were at least 10 to 12 weeks old on Day 1.
Caging: On arrival rabbits were housed individually in cages. The cages were perforated polypropylene trays on a stell rack with mesh walls - no bedding was provided. The minimum cage dimensions are 45 x 62 x 62 cm. Where practicable hay and plastic in-cage shelters were provided for environmental enrichment.
Diet and Water: UAR Rabbit D10 (pelleted) from Charles River UK, Margate was freely available to the animals at all times. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer. Mains water was provided, ad libitum, via water bottles attached to the cage walls. The wter had been periodically analysed for specific contaminants. No contaminants were present in diet, or water at levels which might have interfered with achieving the objective of the study.
Environment: The holding room was designed to permit at least 15 air changes per hour and to maintain temperatures of 16 to 22oC. humidity was not actively controlled but was expected to remain within the range 40 to 80% RH. Recordings of maximum temperature and humidity were made twice daily during the week and once a day on Saturdays, Sundays and public holidays. The room was illuminated by fluorescent strip-lights for twelve hours daily.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
500mg on dermal test site of 30 x 20 cm
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hr
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hr
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hr
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hr
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hr
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occluded application of BMS 528235-01 to intact rabbit skin for four hours was found to be non-irritating
Executive summary:

The study was conducted to determine the irritation or corrosion caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of BMS 528235 -01. The test article (500 mg) was applied to a 30 x 20 mm area on the clipped and moistened dorsum of each of three New Zealand White RAbbits on Day 1. The treated area of skin was covered by a semi-occlusive bandage for four hours. Dermal reactions to treatment were assessed for three days after removal of the dressings. No reactions were observed following a single semi-occluded, topical application of BMS 528235 -01 to intact rabbit skin for four hours. In conclusion a single semi-occluded application of BMS 528235-01 to intact rabbit skin for four hours was found to be non-irritating