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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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline, GLP study
Justification for type of information:
Grouping of structurally similar substances (category approach)

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-toluolsulfonsaure
- Molecular formula (if other than submission substance): C7H8O3S
- Molecular weight (if other than submission substance): 190.2
- Substance type: organic
- Physical state: solid
- Analytical purity: >98%
- Impurities (identity and concentrations): 0.3% H2SO4
- Isomers composition: p-isomer:84.6%; o-isomer: 10.6%; m-isomer: 4.6%
- Purity test date: 01.08.1988
- Lot/batch No.: GPAD 185
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: in the dark at 20C

Test animals

Species:
rabbit
Strain:
New Zealand White

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

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hr
Score:
3.7 - 4
Reversibility:
not fully reversible within: 7 days
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.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is corrosive to the skin. Washing immediately after exposure significantly reduced the severity and duration of the effect.