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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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.