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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Reference
Reference Type:
other: Secondary literature
Title:
In-vivo skin irritation study of the test substance.
Author:
United States Environmental Protection Agency
Year:
2019
Bibliographic source:
HPVIS

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Skin Irritation study was conducted for the given test chemical.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- IUPAC Name: 4,4'-diaminostilbene-2,2'-disulphonic acid
- Mol. formula: C14H14N2O6S2
- Molecular Weight: 370.405 g/mole
- InChI: InChI=1S/C14H14N2O6S2/c15-11-5-3-9(13(7-11)23(17,18)19)1-2-10-4-6-12(16)8-14(10)24(20,21)22/h1-8H,15-16H2, (H,17,18,19)(H,20,21,22)/b2-1+
- Smiles: Nc1ccc(\C=C\c2ccc(N)cc2S(=O)(=O)O)c(c1)S(=O)(=O)O

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: adult, nulliparous, nonpregnant, female rabbits
- Weight at study initiation: weighing 3.4, 3.6 and 4.0 kg were used in the study
- Housing: Rabbits were individually housed in stainless steel cages
- Diet (e.g. ad libitum): Animals were fed 100-120 g standard diet per animal/day
- Water (e.g. ad libitum): allowed free access to tap water
- Acclimation period: They were quarantined for at least 14 days before use.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5 degrees C
- Humidity (%): 40-70% relative humidity
- Air changes (per hr): 500 lux illumination, 12-15 air exchanges per hour.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 Hours
Observation period:
7 Days
Number of animals:
Total = 3
Details on study design:
TEST SITE
- Area of exposure: the dorso-lateral area of the trunk
- % coverage: 6 x 6 cm
- Type of wrap if used: hypoallergenic patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): dressings were removed and the exposed skin was carefully washed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- Method of calculation: Dermal irritation was scored for the degree of erythema/eschar formation according to the method of Draize after 1, 24, 48, and 72 hours and 7 days. Erythema/eschar and edema were each scored on a scale of 0-4 (no effect to severe effect). Any serious lesions or toxic effects other than dermal irritation were recorded. The Draize scores at 24, 48 and 72 hours were added. The total of the three scores was divided by three to give the irritation index. This index was calculated sep arately for erythema/eschar formation and edema. Data interpretation was based on the individual indices of the two most sensitive animals.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test chemical was not irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The given test chemical was not irritating to the skin.
Executive summary:

Skin irritation study was performed for the given test chemical as per OECD Guideline 404 (Acute Dermal Irritation / Corrosion) on New Zealand White rabbits. Three healthy, adult, nulliparous, nonpregnant, female rabbits (strain HC:NZW) weighing 3.4, 3.6 and 4.0 kg were used in the study. They were quarantined for at least 14 days before use. During this period, pooled feces specimens were examined for Coccidia oocysts. Rabbits were individually housed in stainless steel cages under standardized conventional conditions (21 +/- 1.5 degrees C, 40-70% relative humidity, 12 hour light/dark cycle, 500 lux illumination, 12-15 air exchanges per hour). They were fed 100-120 g standard diet per animal/day and allowed free access to tap water. The animals were examined one day prior to use. Only animals not exhibiting any alterations to skin or eyes were used. Approximately 24 hours before the test, fur was clipped from the dorso-lateral area of the trunk (6 x 6 cm) of each of the rabbits. Care was taken to avoid abrasion. Pulverized test material (500 mg) was moistened with deionized water and applied to a hypoallergenic patch. An additional patch as moistened only with water. The patches were placed on the opposite dorso-lateral areas of the trunk of each animal. They were held in place with a semiocclusive dressing for 4 hours. The area of exposure was approximately 6 cm2. After 4 hours, dressings were removed and the exposed skin was carefully washed with water. Dermal irritation was scored for the degree of erythema/eschar formation according to the method of Draize after 1, 24, 48, and 72 hours and 7 days. Erythema/eschar and edema were each scored on a scale of 0-4 (no effect to severe effect). Any serious lesions or toxic effects other than dermal irritation were recorded. The Draize scores at 24, 48 and 72 hours were added. The total of the three scores was divided by three to give the irritation index. This index was calculated sep arately for erythema/eschar formation and edema. Data interpretation was based on the individual indices of the two most sensitive animals. All scores were 0. Hence, the given test chemical was not irritating to the skin.