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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:
Between 21 January 2002 and 18 March 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP.

Data source

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

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:
Test material: OS#135349A
- Storage condition of test material: room temperature and humidity
- Other: Brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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
Conclusions:
The substance is determined to be non-irritating.
Executive summary:

In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts for 4 hours.  Animals then were observed for 14 days.  Irritation was scored by the method of Draize.

 

In this study, Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts is not a dermal irritant.