Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1965
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Does not meet important criteria of today standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
Range-finding study, in which 0.01 mL of test material was applied to the intact skin of 5 rabbits.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The nonfasted animals are maintained on appropriate Rockland diets and water ad libitum except during period of manipulation or confinement.

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.01 mL
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
5
Details on study design:
The undiluted test substance was applied in 0.01 mL amounts to the clipped intact skin of 5 rabbit bellies.

Results and discussion

In vivo

Irritant / corrosive response data:
No injury from undiluted application was observed.
Other effects:
No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No skin irritation was noted following application of 0.01 mL to the belly.