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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study meets the requirements of OECD Guideline 404 (1981) and EU Method B.4 (83/467/EEC)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
83/467/EEC
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
9-ethylcarbazole
EC Number:
201-660-4
EC Name:
9-ethylcarbazole
Cas Number:
86-28-2
Molecular formula:
C14H13N
IUPAC Name:
9-ethyl-9H-carbazole

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2,26 to 2,46 kg
- Housing: Individually in metal cages equipped with feed hoppers and drinking water bowls
- Diet: standard laboratory diet (rabbit diet Preston Farmers Ltd) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14° - 19°C
- Humidity: 54-55 %
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): approx. 15 changes

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item was moistened with 0.5 ml distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit):1.0 ml to moisten the test item
- Lot/batch no. (if required): Ch-B 2322 , Riedel de Haen AG
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
as in EU Method B.4, assessed approximately 30 - 60 min, 24, 48, and 72 h after the removal of the test item

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured at any reading time
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured at any reading time
Irritant / corrosive response data:
Scores (oedema or erythema) were 0 at 1, 24, 48 and 72 h after removal of dressing in all animals.
Other effects:
Staining produced by the test item was present at all reading time points.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In a OECD guideline and GLP compliant primary skin irritation test in rabbits neither erythema nor edema were observed at any reading time. Therefore the test item can be regarded as not skin irritating.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no signs of irritation were observed. Thus, the test item did not induce significant or irreversible damage to the skin.

Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.