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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
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
EC Number:
280-518-3
EC Name:
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
Cas Number:
83682-78-4
IUPAC Name:
1-Propanaminium, 3,3',3''-[phosphinylidynetris(oxy)]tris[N-(3-aminopropyl)-2-hydroxy-N,Ndimethyl-, N,N',N''-tri-C6-18 acyl derivs, trichlorides
Specific details on test material used for the study:
Lot 58033G17
Supplied as 40%

Test animals / tissue source

Species:
cattle

Test system

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

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
ca. 40.7
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

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.