Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only available as a brief summary report

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted test material was applied to the intact and abraded skin of six rabbits for 24 hours, and the skin was subsequently assessed for signs of irritation over a period of a week.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Santicizer 261
- Lot/batch No.: DE 114
no further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
One week
Number of animals:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
Test material removed after 24 hours, presumably by gentle washing but no details given.


SCORING SYSTEM: According to Federal Hazardous Substances Act (FHSA)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
ca. 0.5
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 48, 72 and 168 hours
Score:
ca. 0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 168 hours
Score:
ca. 0
Reversibility:
other: not applicable
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
A 24-hour application of undiluted Santicizer 261 was not irritating to the intact and abraded skin of six albino rabbits.
Executive summary:

Undiluted Santicizer 261 (0.5 mL) was applied to the intact and abraded skin of six New Zealand albino rabbits for 24 hours. The animals were assessed for signs of irritation during the 7-day observation period, and the data scored according to the method of FHSA. Erythema (score of 1) was seen on the abraded and intact skin sites in all six rabbits, 24 hours after removal of the test material. No erythema was noted when assessed at 4, 48, 72 and 168 hours after removal of the test material, and no oedema was reported during the 7-day observation period. The investigators classed the test material as non-irritating when applied to the intact and abraded skin of rabbits. Under EU CLP regulations, this study would indicate that Santicizer 261 is not irritating to the skin.