Hexadecyltrimethylammonium toluene-p-sulphonate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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.

Reference 2

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

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

Link to relevant study records

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

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.