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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:
late 1974 or January 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Principles of method if other than guideline:
6 animals; clipped backs with minor incisions through the stratum corneum; single dose; occluded; 24 hour exposure followed by removal of any remaining test material; reactions scored using the Draize method.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium (xylenes and 4-ethylbenzene) sulfonates
EC Number:
701-037-1
Cas Number:
1300-72-7
Molecular formula:
-
IUPAC Name:
Sodium (xylenes and 4-ethylbenzene) sulfonates

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in metal cages elevated above the droppings
- Diet: ad libitum (Purina Rabbit Chow)
- Water : tap water ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded through the stratum corneum but not disturbing the derma
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 2 one-inch square patches per animal
- Type of wrap if used: plastic binder and adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize, Woodward and Calvery (J. Pharmacol, Exptl. Therap., 82:377, 1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
erythema and eschar average value at 24 hours = 1.3 (intact and abraded skin identical); = 1.2 at 48 hours (intact and abraded identical); = 0.3 at 72 hours (intact and abraded identical);average edema formation value at 24 hr = 1.2 (intact and abraded skin identical); = 0.3 at 48 hours (intact and abraded identical); = 0.0 at 72 hoursPrimary Irritation Index = 1.4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline Federal Hazardous Substance Act (FHSA). The results showed slight erythema and edema in any animals with reversible effects within 72 hours.