1-Propanaminium, 3,3',3''-[phosphinylidynetris(oxy)]tris[N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-, N,N',N''-tri-C6-18 acyl derivs. trichlorides

Endpoint summary

Description of key information

In the Key Eye irritation study, a 4% solution was tested (10% dilution of the 40% material supplied to the laboratory).  

In view of the severity of the result (IVS > 40) Eye Dam 1 has been predicted for the water-free substance as registered, but will be Eye Irrit 2 for the 40% solution as supplied

Key value for chemical safety assessment

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

Study period:

BCOP

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

OECD 437 (Bovine corneal opacity), 2017 to GLP;
4% solution tested (10% dilution of the 40% material supplied to the laboratory).
In view of the severity of the result, Eye Dam 1 can be predicted for the substance as registered.

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot 58033G17
Supplied as 40%

Species:

cattle

Vehicle:

physiological saline

Controls:

yes

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

Applied as 10% solution of material as supplied to the lab; ie final solution of 4% actives. Dilution in 0.9% saline.

Duration of treatment / exposure:

2 hours exposure, 32 C

Duration of post- treatment incubation (in vitro):

90 minutes

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

ca. 40.7

Vehicle controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

4% solution tested (10% dilution of the 40% material supplied to the laboratory).
Althouugh the study was not able to predict classification, effects on the cornea failed to result in Eye Dam 1 criteria, but still gave a significant response.
The material as supplied is therefore considered likely Eye Irrit 2 (see other studies)
In view of the severity of the result, Eye Dam 1 can be predicted for the neat substance as registered.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)