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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
repeated dose toxicity: dermal
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Title:
No information
Author:
Manabe A., Hasegawa T., Chigira H., Itoh K., Wakumoto S.,|Nakayama S., Tachikawa T.; Morphological Changes of Rabbit|Skin by Application of Dentin Primer; Dent. Mater. J. 9(2):|147-152 (1990)

Materials and methods

Principles of method if other than guideline:
Method: other: no data
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Details on exposure:
Route of Administration: dermal
Duration of treatment / exposure:
7 days
Frequency of treatment:
twice a day
Doses / concentrations
Remarks:
Doses / Concentrations:
30 ul, aqueous solution of 35 wt%
Basis:

Control animals:
yes
Details on study design:
Post-exposure period: 7 days

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:
No obvious morphological changes were recognized in the
shaved skin of rabbits after repeated application of HEMA.
HEMA caused insignificant irritation to the dermis.
Histopathology of skin only.

Applicant's summary and conclusion