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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP and reported fully. Klimisch score = 2 based on read across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Storage condition of test material: Ambient
- Other: Dark brown viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2071 to 2480 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): LabDiet 150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24h, 48h, 72h and 8 days
Number of animals:
3/sex
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze binder.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with with paper towels moistened with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, and 72h for each animal.

Any other information on results incl. tables

Table 2: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility

Erythema

Oedema

Max. score: 3

Max. score: 2

24 h

2/1/1/2/1/2

1/0/0/1/0/0

48 h

3/1/0/3/1/2

1/0/0/1/0/0

72h

3/1/1/2/1/2

2/0/0/0/0/0

Average 24h, 48h, 72h

 1.5/1.7/1.7

0.3/0.3/0.3

 Reversibility*)  c  c
 Average time (unit) for reversion  5 days 6 days

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mean scores for each animal at 24h, 48h and 72 h for erythema and oedema, respectively, were less than 2.3 inmore than 2/3 of the animals. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

In a primary dermal irritation study, 6 young adult New Zealand white rabbits were dermally exposed to 0.5 mlof sodium 4-icosylbenzenesulfonate for 4 hours.Animals then were observed for 8 days.

 

In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.