Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Seven days.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Reversibility was not determined as observations were only made for 7 days, no information on test material, size of exposure area not specified, animals were 'restrained' -not clear what this means
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
Four hours.
Observation period:
Seven days.
Number of animals:
Six.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 5 h
Score:
ca. 1.2
Max. score:
2
Reversibility:
other: reversible in 7 days in 5/6 animals
Remarks on result:
other: All animals affected
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 day
Score:
ca. 0.7
Max. score:
1
Reversibility:
other: Reversible by day 7 in 5/6 animals
Remarks on result:
other: Four animals affected
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 2 days
Score:
ca. 0.3
Max. score:
1
Reversibility:
other: reversible in 5/6 animals by day 7
Remarks on result:
other: Two animals affected
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 days
Score:
ca. 0.3
Max. score:
1
Reversibility:
other: reversible in 5/6 animals by day 7
Remarks on result:
other: Two animals affected
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 days
Score:
ca. 0.2
Max. score:
1
Reversibility:
other: reversible in 5/6 animals by day 7
Remarks on result:
other: One animal affected
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 5 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 day
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 2 days
Score:
ca. 0.2
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Only one animal affected
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 days
Score:
ca. 0.2
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Only one animal affected
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 days
Score:
ca. 0.2
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Only one animal affected
Other effects:
No other effects reported in the summary report.

Any other information on results incl. tables

This primary skin irritation study resulted in slight erythema all six rabbits (grade 1 in five, grade 2 in one animal) persisting to seven days in one animal only (grade 1), oedema in one animal on days 2 -7 (grade 1), and desquamation in three rabbits after one day, which persisted to day 7 in one animal only. These minor effects would be expected to fully reverse by day 14.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a limited summary of a primary skin irritation study, not conducted to GLP, Organofunctional Silane Y-9445 was very slightly irritating to the skin of rabbits (minor erythema in 6/6 animals and minor oedema in 1/6 animals). These minor effects persisted to day 7 in one animal only, and would be expected to fully reverse by day 14.
Executive summary:

Male and female New Zealand white rabbits were dosed with 0.5 ml Organofunctional Silane Y-9445 onto their clipped intact skin. The exposure area was covered with a gauze patch and loosely covered with impervious sheeting. The test substance was applied to the skin of six animals for four hours, during which the animals were 'restrained' (not clear what this means). Excess test material was removed after four hours. Skin reactions were scored by the method of Draize, at one hour, 24 hours, two days, three days and up to seven days where necessary. This primary skin irritation study resulted in slight erythema all six rabbits (grade 1 in five, grade 2 in one animal) persisting to seven days in one animal only (grade 1), slight oedema in one animal on days 2 -7 (grade 1), and desquamation in three rabbits after one day, which persisted to day 7 in one animal only. These minor effects would be expected to fully reverse by day 14.