Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study details, but recognised guideline followed. Study referenced in EU Risk Assessment Report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The skin of 3 albino rabbits was semi-occlusively exposed to 0.5 mL of undiluted test material (purity > 99%) per animal for 4 hours.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Not specified

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three
Details on study design:
As guideline

Results and discussion

In vivo

Irritant / corrosive response data:
All animals showed slight erythema that reversed within 24 hours.

Any other information on results incl. tables

No further data available.

Applicant's summary and conclusion