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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Dec 1987 - 02 Jan 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Comparable to guideline study with acceptable restrictions (purity of test substance not specified, first reading time point 30 minutes after patch removal).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12. May 1981
Deviations:
yes
Remarks:
purity of test substance not specified, first reading time point 30 minutes after patch removal
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)
EC Number:
407-560-9
EC Name:
4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)
Cas Number:
107934-68-9
Molecular formula:
C25H18Cl2N2
IUPAC Name:
4-[9-(4-amino-3-chlorophenyl)-9H-fluoren-9-yl]-2-chloroaniline
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2381 - 2433 g
- Housing: individually in screen-bottom stainless steel cages (heavy gauge)
- Diet: measured amount of Purina High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 29 - 30
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g (moistened with 0.9% saline) at the site of application
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
reading time points: 0.5, 24, 48 and 72 hours
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: back and flank (approximately 6 cm2)
- Type of wrap if used: 2.5 x 2.5 cm gauze patch, secured with paper tape and loosely overwrapped with Saran Wrap and fixed with Elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tapwater and paper towels
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No effects on skin were observed at any reading time point.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In an skin irritation study in rabbits, performed equivalent or similar to OECD 404 test guidelines, no irritation was observed.
Executive summary:

Dermal irritation was tested using three rabbits exposed to the test substance, for 4 hours using a semiocclusive dressing, according to OECD 404 test guideline and according to GLP principles.

No effects on skin were observed at any reading time point. No other observations were recorded.

Based on the results, the test substance is not considered as irritating to skin and no classification for dermal irritation is needed according to EC regulation 1272/2008.