Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
58 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
Positive control, Vehicle Control & Medium Control are used for STE test

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: Saline
Controls:
other: Positive control, Vehicle Control & Medium Control are used for STE test
Amount / concentration applied:
Both 5% and 0.05% concentration of samples were tested for Eye irritation.
Number of animals or in vitro replicates:
3 In Vitro replicates

Results and discussion

In vitro

Results
Irritation parameter:
other: Cell Viability
Value:
> 70 - <= 70
Vehicle controls validity:
valid
Negative controls validity:
not valid
Positive controls validity:
valid
Remarks on result:
other: The test material falls under " No prediction can be made" Category of UN GHS Classification.

Applicant's summary and conclusion

Interpretation of results:
other: The test material falls under " No prediction can be made" Category of UN GHS Classification.
Conclusions:
The study "In-vitro Eye Irritation by Short time Exposure (STE) Test Method" confirms that Thioctamidoethyl Dimethylamine Maleate is considered as " No prediction can be made" as per the UN GHS for classification of Chemicals following OECD guidelines No. 491 using SIRC cell line.