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Administrative data

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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)
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:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)
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

Additional information

Justification for classification or non-classification