Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products Inc.
- Weight at study initiation: 4038 to 5232 grams.
- Housing: Individual suspended mesh-bottom cages.
- Acclimation period: minimum of 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66-69F.
- Humidity (%):32-50%.
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark.

IN-LIFE DATES: February 25 1993 through March 29, 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: mineral oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
In group 1 the test material was dosed (0.5ml/site) as received. In group 2, there were four intact sites per rabbit. Each rabbit was administered single applications (0.5ml/site) of the test material at at 6.25, 12.5, 25, and 50% concentration in mineral oil .
Duration of treatment / exposure:
The test substance was administered once per site and remained in contact with the skin for 4 hours followed by removal with disposable paper towels moistened with light, white mineral oil.
Observation period:
The skin was examined and graded for dermal reaction at 24 and 72 h following patch removal.
Number of animals:
12 females
Details on study design:
TEST SITE
On the day prior to dosing, the hair was removed from the backs of the rabbits using an Oster small animal clipper. Each 0.5 milliliter dose was applied under a 2-ply 1" x 1" gauze patch, overwrapped with a gauze binder and secured with Dermiform Tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period (4 hours). Following the exposure period, residual test substance was removed with
disposable paper towels moistened with light, white mineral oil.

SCORING SYSTEM: Dermal Irritation was graded in accordance with the Draize method of scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: as supplied concentration/undiluted
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: as supplied concentration/undiluted
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 6.25% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.08
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 6.25% in mineral oil
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 12.5% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 12.5% in mineral oil
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 25% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.9
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 25% in mineral oil
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.83
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 50% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 50% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.5
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 6.25% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.7
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 12.5% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
3.5
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 25% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
4
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 50% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
4.25
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: as supplied concentration/undiluted
Irritant / corrosive response data:
Undiluted test material induced moderate erythema and very slight to slight edema on all rabbits. There were no other dermal findings.

The 6.25% concentration of the test material induced very slight to slight erythema on all rabbits and very slight edema on one rabbit. There were no other dermal findings.
The 12.5 % concentration of the test material induced slight to moderate erythema and very slight edema on all animals. There were no other dermal findings.

The 25 % concentration of the test material induced slight to moderate erythema and very slight to slight edema on all animals. There were no other dermal findings.

The 50 % concentration of OS# 29802K induced moderate erythema and very slight to slight edema on all rabbits. There were no other dermal findings.


Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test substance would be classified as a Category 2 in accordance with the classification system of GHS.
Executive summary:

The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. There were two groups of six rabbits. In Group 1, single 0.5 milliliter doses of undiluted test material were applied to a single site on each animal's back. In Group 2, single 0.5 milliliter doses of the test material at concentrations of 6.25, 12.5, 25 and 50% (weight to volume in mineral oil) were applied to four distinct application sites on each animal's back; each animal received a single dose of each concentration.Alldoses were applied under semi-occlusive dressing for a four hour exposure period. At completion of exposure the bandages were removed and the sites washed with light, white mineral oil and disposable paper towels. Application sites were evaluated in accordance with the method of Draize at approximately 24 and 72 hours after patch removal.

There were no deaths or significant body weight changes during the study period.

In Group 1, thePrimaryIrritation Index was calculated to be 4.3 for sites treated with undiluted test material.

In Group 2, Primary Irritation Indices of 1.5, 2.8, 3.5 and 4.0 were calculated for 6.25, 12.5, 25 and 50% w/v concentrations of the test material in mineral oil, respectively.

 

Based on the results of this study, the test substance (at all concentrations tested) would be classified as a Category 2 in accordance with the classification system of GHS.