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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
13/07/2010-18/06/2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
other: Commission Regulation 440/2008, L142, Annex Part B
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 6-(3-chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
EC Number:
638-800-2
Cas Number:
949465-91-2
Molecular formula:
C25H27ClFNO5
IUPAC Name:
ethyl 6-(3-chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art.9.2, N.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
TEST ANIMALS
- Source: Charles River Deutchland
- Age at study initiation: approx. 14 weeks old
- Weight at study initiation: 2.7-2.9 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x/ hour
- Photoperiod (hrs dark / hrs light): artificial light, 12/ 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Duration of treatment / exposure:
The test item was held in contact with the skin throughout 4-hour period.
At the end of the exposure period, residual test item was removed by using tap water.
Observation period:
All animals were observed for 72 hours after the patch removal.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: media
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
other: media
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, single dermal application of the test item GS-9205 to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation 1272/2008, the test item GS-9205 does not have to be classified and has no obligatory labelling requirement for skin irritation.