Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TS: 2, 2', 2''-Nitrilotriethanol, propoxylated, (Mm = approx. 340 g/mol)

Lot No: 20104

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye was used as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Observation period (in vivo):
1, 24, 48 and 72 hour
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24h-observation. Treated eyes appeared normal at the 48-hour and 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification according to EU labelling.