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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted to guidelines and GLP and is considered reliable without restriction for assessment of the test material. Because teh study is being used for read-across to a similar material, the reliability is reduced to reliable with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

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

Test material

Constituent 1
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
IUPAC Name:
sodium 4-icosylbenzenesulfonate
Details on test material:
- Storage condition of test material: room temperature and humidity
- Other: Brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.9-3.1 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour 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/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled 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: 24h/48h/72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.
Other effects:
Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.

Any other information on results incl. tables

Table 1: 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: 4

Max. score: 2

60 min

1/0/1

 0/0/1

24 h

1/0/1

 0/0/1

48 h

1/0/2

 0/0/1

72 h

0/0/2

 0/0/1

Average 24h, 48h, 72h

 0.7/1/0.7

 0.3/0.3/0.3

Reversibility*)

 c/c/c

 c/c/c

Average time (unit) for reversion

 72/0/14d

 0/0/14d

 

*) 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
Executive summary:

In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of sodium 4-icosylbenzenesulfonate for 4 hours.  Animals then were observed for 14 days.  Irritation was scored by the method of Draize.

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