Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 9 - 16, 1979
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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium (xylenes and 4-ethylbenzene) sulphonate
EC Number:
943-024-5
Molecular formula:
C8H13NO3S
IUPAC Name:
Ammonium (xylenes and 4-ethylbenzene) sulphonate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boswell, S-K & Lomax
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing:individually 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

IN-LIFE DATES: From: October 9, 1979 To: October 16, 1979

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
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 of undiluted test material
- Concentration (if solution): no data

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
24 hours after which the plastic binder and patches were removed and any remaining material was wiped off the treated areas
Observation period:
At 24, 48, 72 and 96 hours and at 7 days following exposure
Number of animals:
6 of random sex
Details on study design:
The backs of the animals were clipped free of hair. Two sets of abrasions (minor incisions through the stratum corneum, but not deep enough to disturbe the derma) were made approximately ten centimeters apart on the right side of the back of each animal, while the skin of the left side remained intact. The animals were immobilized in a restrainer rack and 0.5 mL of the undiluted test substance applied to 2 intact and 2 abraded areas on each rabbit. Patches were first taped in place and then the entire trunk of the animal was enclosed in a plastic binder for 24 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Within 24 hours in all animals there was a barely perceptible to slight erythema and edema. This condition continued in all six animals at 48 hours and in five of six animals at 72 hours and 96 hours. The skin of all animals were reaction free at 7 days.
Other effects:
None reported

Any other information on results incl. tables

See attached tables

Applicant's summary and conclusion

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

The skin irritation of Ammonium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline US Federal Register 1964.
The results showed slight erythema with reversible effects within seven days. No edema were seen in any animals.