Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Justification for type of information:
in vivio study conducted 1998 and reported in separate endpoint record.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:

- 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
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 hr
Score:
>= 3.7 - < 4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 hr
Score:
2
Max. score:
2
Reversibility:
not specified
Other effects:
Mean Edema score was 2.0
Brown discolouration

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.

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

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Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2)
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The test substance, Toluene-4 -sulphonic acid (p-TSA) was found to be corrosive to the skin.

On this basis, eye irritation can be assumed and therefore an an eye irritation study is not required.

In consideration that the substance is a particulate solid, it can be assumed that inhalation of CETATS powder will cause respiratory irritation due to dissociation to p-TSA and cetrimonium chloride in the lung mucous membranes.