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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
Study period:
13 Aug 1985 - 16 Aug 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 12 May 1981)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-ethyl-o(or p)-toluenesulphonamide
EC Number:
232-465-2
EC Name:
N-ethyl-o(or p)-toluenesulphonamide
Cas Number:
8047-99-2
Molecular formula:
C9H13NO2S
IUPAC Name:
N-ethyl-o(or p)-toluenesulphonamide
Test material form:
liquid: viscous
Remarks:
Colour: light yellow
Details on test material:
Ketjenflex 8 (NETSA)
Chemical name in report: N-ethyl-o/p-toluenesulfonamide (or N-substituted toluene sulphonamide)
Description: light yellow viscous liquid
Purity 100% (or 90%)

Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Specific details on test material used for the study:
- Chemical name: N-substituted toulene sulphonamide
- Trade name/code: Ketjenflex 8
- Impurity: Approx. 10% o/p toulene sulfonamide
- Specific gravity: Approx. 1200 kg/m3 (at 25 ̊ C)
- Solubility: Organic solvents except petroleum hydrocarbons
- Flash point: 224 ̊ C
- Boiling point: > 340 ̊ C
- Vapour pressure: < 1mm Hg at 150 ̊ C
- Appearance: Light yellow, viscous liquid
- Storage: At ambient temperature in the dark
- Stability: Practically unlimited

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF quality
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Obtained from The Broekman Institute, Someren,The Netherlands.
- Age at study initiation: Approximately 15 weeks old
- Weight at study initiation: 2750, 2701 and 2865 g
- Housing: In metal cages with perforated floors
- Diet (e.g. ad libitum): They were fed standard laboratory animal diet (100 g per day), obtained from Hope Farms, woerden (LK-01, pellet diameter 4mm)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Quarantine period was 7 days followed by an acclimation period of approximately 2.5 months

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): Relative humidity 50-70
- Photoperiod (hrs dark / hrs light): The artificial light sequence was 12 hours light, 12 hours dark.

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): 0.5 ml
- Concentration (if solution): Undiluted

Duration of treatment / exposure:
Exposure duration was 4 hours
Observation period:
The exposed skin areas were examined for signs of erythema and oedema, and the responses were scored at 60 minutes, and approximately 24, 48 and 72 hours after removal of the dressing. For reference, the control site on the contralateral flank was used.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Test substance was applied to the right flank of each animal, the left flank being covered with the same dressing without test substance
- Coverage: approximately 10cm x 10 cm
- Type of wrap if used: gauze patch
- Administration: 0.5ml of the test substance was applied to a 6cm^2 gauze patch, which was attached with a drop of petrolatum to aluminum foil and mounted on permeable tape (Micropore, #M, St Paul, USA). This was then wrapped with flexible bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test substance was removed using a tissue moistened with tap water after exposure duration of 4 hours.

OBSERVATION TIME POINTS
- 60 minutes, 24 hours, 28 hours and 72 hours after removal of the dressing

SCORING SYSTEM:
- Method of calculation: Skin irritation grading system based on OECDTG 404 (1981)

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:
0
Remarks on result:
other: Mean value
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Mean value
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Mean value
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Mean value
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Mean value
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Mean value
Irritant / corrosive response data:
The skin of all three animals showed no reactions. The primary irritation index was 0 ( total of 24 and 72 hours scores for erythema and oedema, divided by 6).

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Conclusions:
Under the conditions of this test the skin of all three animals showed no reactions. The primary irritation index was 0.
Executive summary:

A skin irritation study was conducted according to OECD guideline 404, 1981, using the test material Ketjenflex 8 on the flank skin of 3 female New Zealand white strain rabbits. Each test site was treated with 0.5 ml of the undiluted test material for 4 hours using semiocclusive dressing. Observations for dermal irritation were made at 1, 24, 48 and 72 hours after removal of the patch. No significant test substance related effect was observed. The primary skin irritation index amounted to 0. Ketjenflex 8 can therefore be considered as non irritating to skin under the conditions of this study and does not have to be classified according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).