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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:
From 6 July, 1993 to 13 July, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Guidelines followed
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-anilino-3-nitro-N-phenylbenzenesulphonamide
EC Number:
225-862-7
EC Name:
4-anilino-3-nitro-N-phenylbenzenesulphonamide
Cas Number:
5124-25-4
Molecular formula:
C18H15N3O4S
IUPAC Name:
4-anilino-3-nitro-N-phenylbenzenesulfonamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Terasil gelb GWL roh feucht (FAT 36014/F)
- Physical state: Yellow-brown powder
- Analytical purity: 90.7%
- Batch No.: 292347.26
- Expiration date of the batch: April 01, 1998
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Lot/batch No.of test material: Terasil gelb GWL roh feucht (FAT 36014/F)
- Expiration date of the lot/batch: April 01, 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test substance was ground to a powder using a mortar and pestle.The powdery test substance was applied with the aid of a patch. The patch was moistened with distilled water, immediately before application, to ensure close contact of the test substance to the animal's skin.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx 12 weeks
- Weight at study initiation: 2374-2688 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d.
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least 5 d after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: From July 6, 1993 to July 13, 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated flank of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Approx 10x15 cm²
- Type of wrap if used: The test substance was applied using a moistened Scotchpak-non-woven patch mounted on Micropore tape. The dressing was wrapped around the abdomen and secured with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed at the end of the exposure period using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Following exposure a yellow staining of the treated skin-area was noted after removal of the test substance minutes/hours/days after application.
75 minutes, 24 hours, 48 hours, 72 hours, 7 days

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:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. The body weights and variability in body weight gain of the animals were considered to be normal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Other effects:
Except for yellow staining of the treated skin in all three animals, there were no signs of corrosion, body weight variability, toxicity or mortality in any animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36014/F is not irritating to the skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the test substance (of 90.7 % purity) in New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4 in compliance with GLP. 500 mg of test substance was applied to a shaved skin area of 10 cm x 15 cm on one flank of each animal under a moistened 2 cm x 3 cm patch. The patch was held in contact with the skin for 4 h. Animals were scored for irritation reactions after 75 minutes, 24, 48 and 72 h, and then 7 d. Animals were monitored daily for viability, mortality and clinical signs. Body weights were recorded pre-test and at study termination. Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. This staining was found to have been reversed by 72 hours in two animals, however it was still present in one animal by the end of observation period of 7 days. The body weights and variability in body weight gain of the animals were considered to be normal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the above findings, the scores obtained does not meet the classification criteria as set by the Regulation (EC) No. 1272/2008. Hence, the test substance was considered to be not irritating to the skin.