Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1996-06-04 to 1996-08-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Lot No.: 0998603612
Purity: 59.6 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approximately 2.0 to 3.5 kg
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 21.7 °C (66 - 71 °F)
- Humidity (%): 56 - 78
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g / 100 % concentration
Duration of treatment / exposure:
4 hours
Observation period:
up to 14 days after removing the gauze
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: the dorsal area of the trunk
- % coverage: approximately 1 inch x 1 inch
- Type of wrap: 1 x 1 inch square 4-ply gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: after 4 hours of exposure; cleaned with wet gauze and then with dry
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours up to 14 days after patch removal

SCORING SYSTEM:
- Method of calculation: Macroscopic Dermal Grading System based on Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of severe irritation
Remarks:
injuries in depth
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of severe irritation
Remarks:
injuries in depth
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of severe irritation
Remarks:
injuries in depth
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of severe irritation
Remarks:
injuries in depth
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of severe irritation
Remarks:
injuries in depth
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
probability of severe irritation
Remarks:
injuries in depth
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings of eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively and apparent necrosis and eschar which were noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.
Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit.
Other effects:
Apparant necrosis in different formations were observed.

Any other information on results incl. tables

As the observed erythema effect were more severe than the scorring scale allows to be classified, an additional score was added M-4 (= 5) which represented the most severely affected areas - injuries in depth. When this score was assigned additionally the type of injuries were described.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
It was determined that the test item corrosive to skin.
Executive summary:

The potential irritant and/or corrosive effects of the test item were evaluated on the skin of New Zealand White rabbits in a study performed according to OECD 404, EC Regulation 124/92 method B.4 and EPA OPPTS 798.4470. Each of six rabbits received a 0.5 g dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 14 days following patch removal.

Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings included eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively, and apparent necrosis and eschar which were both noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.

Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit.