Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Endpoint summary

Description of key information

The substance did not lead to skin irritation during in-vitro testing

The severity of the results in the Eye Irritation (BCOP) study was sufficiently low to confirm that the substance was not Eye Dam 1

However, in view of signficant effects, and taking into account the potential irritancy of at least one of the main starting materials / dissociation products, a classification of Eye Irrit 2 is considered valid and no further testing has been performed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 minute exposure

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study 2018 to GLP.
All quality crieteria met

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

PAH 330/132/1A
The sample had been partly concentrated up to ca 50% (repored 49.38) to prepare as concentrated form of the material as possible for testing.
Attempts to concentrate further appeared to impact on stability.

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent vehicle

Amount/concentration applied:

The test item was applied topically to the corresponding tissues ensuring uniform covering.
10 µL (26.3 µL/cm2) of the test item was applied to the epidermis surface

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Average

Value:

ca. 66.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

No other effects reported
The solution containing the test item was a yellow color. This color was attributed to the intrinsic color of the test item itself. It was therefore unnecessary to run color correction tissues

Interpretation of results:

GHS criteria not met

Conclusions:

Considered non-classified

Executive summary:

The relative mean viability of the test item treated tissues was66.6% after the 15‑Minute exposure period and 42‑Hours post‑exposure incubation period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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

Justification for type of information:

Guideline study performed 2017 to GLP

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification: Dodecenyl succinic acid, compound with 2,2',2''-nitrilotriethanol (partially solvent extracted)
Batch: PAH 330/132/1A
CAS Number: 64396-12-9
Purity: ~49.38%
Physical state/Appearance: slightly opaque amber colored viscous liquid

Species:

cattle

Details on test animals or tissues and environmental conditions:

Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals

Vehicle:

unchanged (no vehicle)

Controls:

yes

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 mL of the test item or control items were applied to the appropriate corneas.

Duration of treatment / exposure:

The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 10 minutes.

Duration of post- treatment incubation (in vitro):

2 hours

Irritation parameter:

cornea opacity score

Run / experiment:

1

Value:

ca. 24.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7.

The negative control gave opacity of ≤3.0 and permeability ≤0.077.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The severity of the results was sufficiently low to confirm that the substance was not Eye Dam 1
However, in view of signficant effects, and taking into account the potential irritancy of at least one of the main starting materials / dissociation products, a classification of Eye Irrit 2 is considered valid and no further testing has been performed.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available