Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
unsuitable test system

Data source

Reference
Reference Type:
publication
Title:
About the pharmacologic and toxic activities of E-Caprolactam.
Author:
Hohensee, F.
Year:
1951
Bibliographic source:
Fiber Res. and Textile Tech. 1, 299-303. Cited in: Henschler, D. (Hrsg.), Gesundheitsschaedliche Arbeitsstoffe. Toxikologisch-arbeitsmedizinische Begruendung von MAK-Werten: Caprolactam (1975), 1.-17. Lfg., Verlag Chemie (1991)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Over a time period of 24 days, 5 and 10% of the test substance was applied daily onto the cornea and the mucosa of the eye (3-4 drops) of 2 animals.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
ε-caprolactam
EC Number:
203-313-2
EC Name:
ε-caprolactam
Cas Number:
105-60-2
Molecular formula:
C6H11NO
IUPAC Name:
azepan-2-one

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
physiological saline
Controls:
not specified
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
2

Results and discussion

Any other information on results incl. tables

No irritation was observed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No irritation was observed in rabbits.
Executive summary:

Over a time period of 24 days, 5 and 10% of the test substance was applied daily onto the cornea and the mucosa of the eye (3-4 drops) of 2 rabbits. No irritation was observed.