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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
repeated dose toxicity: dermal
Remarks:
other: 5 applications of 0.2 ml
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: methological deficiencies (e.g. low number of animals, purity of TS not reported) but carefully described observations

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1970
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
The liquid (0.2 ml) was applied to the shorn backs of 3 female rats under an occlusive dressing on alternate days for 5 applications. On the intervening day the dressing was removed and the treated area was cleaned with methylated spirit.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: no data

Test animals

Species:
rat
Strain:
other: young adult Alderly Park strain
Sex:
female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on exposure:
Route of Administration: dermal
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
10 d
Frequency of treatment:
5 applications on alternate days
Doses / concentrations
Remarks:
Doses / Concentrations:
0.2 ml (= 216 mg)/animal/application
Basis:

No. of animals per sex per dose:
3 female rats
Control animals:
no
Details on study design:
Post-exposure period: no

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

hyperkeratinisation occured after the second application and developed after the second 
application and developed into necrosis. The test was terminated early. One animal died 
after the third application. Tissues were submitted for histological examination. 
The skin at the the application site showed necrosis of the epidermis and a marked 
fibroblastic reaction of the dermis.

Applicant's summary and conclusion

Executive summary:

The liquid (0.2 ml) was applied to the shorn backs of 3 female rats under occlusive dressing on alternate days for 5 applications. On the intervening day the dressing was removed and the treated area was cleaned with methylated spirit. Hyperkeratinisation occured after the second application and developed into necrosis. The test was terminated early. One animal died after the third application.

Hyperkeratinisation occured after the second application and developed after the second application and developed into necrosis. The test was terminated early. One animal died after the third application. Tissues were submitted for histological examination.The skin at the the application site showed necrosis of the epidermis and a marked fibroblastic reaction of the dermis.