Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A guideline has been followed and the study is GLP compliant. However, the data in the migrated NONS file is deficient, and the study has not been seen to confirm quality.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
Principles of method if other than guideline:
A guideline has been followed
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Test system

Vehicle:
other: Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Controls:
other: Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
9
Details on study design:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Score:
2.05
Remarks on result:
other: Max. duration: h; Max. value at end of observation period:.
Irritation parameter:
chemosis score
Basis:
mean
Score:
3.17
Remarks on result:
other: Max. duration: h; Max. value at end of observation period:.
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
1.33
Remarks on result:
other: Max. duration: h; Max. value at end of observation period:.
Irritation parameter:
iris score
Basis:
mean
Score:
0.83
Remarks on result:
other: Max. duration: h; Max. value at end of observation period:.
Irritant / corrosive response data:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Other effects:
No observations were recorded at the end of one hour. Scattered, diffuse corneal opacity and slight iridial changs persisted for up to 21 days. The reversibility of the eye effects is unclear from the information in the Belgian c.a. summary, but irritation would appear to have been protracted. Irrigation of the eyes for 30 seconds reduced only slightly the severity of the lesion.

Any other information on results incl. tables

No further information about the results is stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000]. Permission to refer granted by ECHA

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
N-(n-octyl)-2-pyrrolidinone is classified as a severe eye irritant, R41. Howeer, in view of the use of R34, these R phrases are not required
Executive summary:

An annex V guideline has been followed. N-(n-octyl)-2 -pyrrolidinone is found to be severely irritating to eyes, with an R41 classification. However, this is overridden in view of the R34 classification.