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Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene
EC Number:
620-459-6
Cas Number:
130841-23-5
Molecular formula:
C9H3Cl2F6NO3
IUPAC Name:
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene
Details on test material:
- Test article: CGA 230672 techn.
- Purity test date: 97,3 %
- Lot/batch No.: P. 906005

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K Thomae GmbH, Chemisch-pharmazeutische Fabrik
- Age at study initiation: 9 - 13 weeks old
- Weight at study initiation: 2700 - 2880 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): yes (standart rabbit pellet, Nafag No. 814)
- Water (e.g. ad libitum): yes
- Acclimatisation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4 hours
Observation period:
skin reactions were evaluated 1, 24, 48 and 72 hours after removing the gauze patches.
The animals were checked daily for systemic symptoms and mortality.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: gauze patch (ca. 12-16 cm²) bearing 0,5 ml of the test article was applied to the right flank of each animal.
- coverage: the patches were loosely covered with an aluminium foil (ca. 36 cm²)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Remarks:
until the end of the observation period on day 3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
until the end of the observation period on day 3
Irritant / corrosive response data:
non-irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU