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

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2018

Materials and methods

Test guideline

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)

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

264-867-9

EC Name:

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

Cas Number:

64396-12-9

Molecular formula:

C16H28O4.C6H15NO3

IUPAC Name:

Succinic acid, dodecenyl-, triethanolamine salt (1:1)

Test material form:

liquid

Details on test material:

Commercial grade containing approximately 45% actives

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

Test animals / tissue source

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

Test system

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

Results and discussion

In vitro

Results

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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.