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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: Read Across from analogue substance
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
p-toluenesulfonic acid
IUPAC Name:
p-toluenesulfonic acid
Constituent 2
Chemical structure
Reference substance name:
Toluene-4-sulphonic acid
EC Number:
203-180-0
EC Name:
Toluene-4-sulphonic acid
Cas Number:
104-15-4
Molecular formula:
C6H8O3S
IUPAC Name:
4-methylbenzene-1-sulfonic acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Temp: 20 ± 3 °C
Relative humidity: 50 ± 20 %
Light: 12 hours
Food: ad libitum (Altromin 2123 Haultungsdiat supplied by Altromin-Gmbh)
Water: ad libitum tap water

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 hour
Observation period:
7 days
Number of animals:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
30-60 minutes after removing the plaster up to the 3rd day post administration, the skin of the animals showed a clearly circumscribed to severe erythema and a noticeable oedema. In addition, the skin surface was partly dry and brittle and flaky or brown over a large area. Hardening and scab formation were also observed. 7 days post administration the skin of the tier showed a clearly circumscribed erythema and a leitches odema. In addition, a dry and brittle skin surface, scab formation, an open wound and the formation of scars were observed.
Other effects:
Mean Edema score was 2.0, Brown discolouration

Any other information on results incl. tables

3 additional animals were exposed for 3 minutes each. The mean erythema score was 0.6 and the mean edema score was 0. Effect was reversible within 72 hours.

Washing immediately after exposure significantly reduced the severity and duration of the effect.

See attached table for details.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Skin Corrosion 1C, H314: Causes severe skin burns and eye damage.
Executive summary:

The skin irritation potential of Toluene 4-sulphonic acid was assessed following official guideline OECD 402, Acute Skin Irritation/Corrosion. The skin of the animals showed a clearly circumscribed to severe erythema and a noticeable oedema. In addition, the skin surface was partly dry and brittle and flaky or brown over a large area. Hardening and scab formation were also observed. The effects were seen after 7 days post administration.