Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EU method B.40 bis (in vitro skin corrosion: Human skin model test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Frey-Tox GmbH, Osteroda 38, 04916 Herzberg (Elster)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Control samples:

yes, concurrent vehicle

yes, concurrent positive control

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

water

Controls:

yes

Amount / concentration applied:

25 mg ± 2.5 mg of the test item were applied together with 25 µL demineralised water

Duration of treatment / exposure:

3 min, 1 h

Observation period:

measurement directly following after treatment

Number of animals:

2 replicates of tissue from epidermis skin model EpiDerm

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min

Value:

101.5

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 h

Value:

105.1

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the in vitro study the test is classified as non-corrosive according to the OECD guideline 431.

Executive summary:

Two tissues of the human skin model EpiDermTM were treated with the test substance for 3 minutes and 1 hour, respectively. Demineralised water was used as negative control and 8 M KOH was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion. The positive control showed clear corrosive effects for both treatment intervals.

After 3 minutes treatment with the test substance, the mean value of relative tissue viability was increased to 101.5%. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, the mean value of relative tissue viability was increased to 105.1%. This value, too, is above the threshold for corrosion potential (15%).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

LAUS GmbH Auf der Schafweide 20 D-67489 Kirrweiler

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Slaughtered cattle that were between 12 and 60 months old

Vehicle:

physiological saline

Controls:

yes

Duration of treatment / exposure:

1 h

Observation period (in vivo):

4 h

Number of animals or in vitro replicates:

3 bovine corneas were used.

Irritation parameter:

in vitro irritation score

Value:

20.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.

The negative or solvent control has to show an IVIS <= 3: 0.71

Values for positive controls were within the range of historical data of the test facility 75.32 -143.16: 104.42

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the conditions of this test, the test item Stearyl Sulfobetaine showed effects on the cornea of the bovine eye. The calculated mean IVIS was 20.70.
According to OECD Guideline no. 437 (Jun. 2020), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

Although the in vitro test came to a borderline conclusion, the test substance is classified as Skin Irrit. 2, H315: Causes skin irritation and Eye Irrit. 2A, H319: Causes serious eye irritation.as a worst case approach.