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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
EC Number:
274-263-7
EC Name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
Cas Number:
70024-69-0
Molecular formula:
Cannot be adequately determined for this UVCB substance
IUPAC Name:
Petroleum, mono-C16-24 linear saturated alkaryl derivatised benzenesulphonic acid calcium salts
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 or test system 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.