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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Daltolac XR 159
- Lot/batch No.: RZW023
- Expiration date of the lot/batch: Twenty-one months at customer
- Physical Description: Light yellow viscous liquid
- Composition/Purity: Reaction mass of 2,2'-Oxydiethanol, propoxylated and formaldehyde polymer with benzenamine and 2-methyloxirane
Stability: The test article was expected to be stable under standard laboratory conditions for the duration of testing.
Storage Conditions: Room temperature (10-30ºC)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Total Number: Three
Gender: Male
Age Range: 11-12 weeks at start of dosing; records of dates of birth for animals used in this study are retained in the Calvert archives.
Body Weight Range: 2.1 to 2.3 kilograms at the outset (Day 1) of the study.
Animal Source: Harlan, Oxford, MI
Experimental History: Purpose-bred and experimentally naïve at the outset of the study.
Identification: Ear tag and cage card

ENVIRONMENTAL CONDITIONS
Housing: Animals were individually housed in compliance with USDA Guidelines. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
Lighting: 12 hours light/12 hours dark
Room Temperature: 17 to 21°C
Relative Humidity: 26 to 58%
Food: All animals had access to PMI Certified Hi-Fiber Rabbit Diet #5325 as per Calvert SOP. The lot number(s) and specifications of each lot used are archived at Calvert. No contaminants were known to be present in the certified diet at levels that would be expected to interfere with the results of this study. Analysis of the diet was limited to that performed by the manufacturer, records of which are maintained in the Calvert archives.
Water: Tap water was available ad libitum, to each animal via an automatic watering device. The water is routinely analyzed for contaminants as per Calvert SOP’s. No contaminants were known to be present in the water at levels that would be expected to interfere with the results of this study. Results of the water analysis are maintained in the Calvert archives.
Acclimation: Study animals were acclimated to their housing for a minimum of 5 days prior to dosing.

IN-LIFE DATES: From: 7 April 2009 To: 13 April 2009

Test system

Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
A dose of 0.5 ml of the liquid test article was applied to each of the test sites. The test article was applied directly on the intact skin sites.
Duration of treatment / exposure:
3 and 60 minutes, and 4 hours.
Observation period:
After removal of the patches:
immediately and then 30-60 minutes, and 24, 48 and 72 hours
Number of animals:
3
Details on study design:
The pH of the article was determined by the testing facility prior to experimental start. The method of pH determination was Instachek (HJ613) and the pH of the liquid test article was 6.
Within 24 hours before initiation of the test, fur was removed from the dorsal trunk of each animal by clipping. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. The animals were clipped as deemed necessary during the study to facilitate observations.
In the interest of animal welfare the test began with the application of the test article to three test sites on a single animal. The test article was applied, as described below, to three intact skin sites on a single animal. The test article was applied, under 5 cm x 5 cm gauze (at least 4-ply) pads, loosely held in contact with the skin with a sheet of rubber dam and wrapped with a semi-occlusive dressing which was held in place with non-irritating tape to three intact skin sites on the animal. The first patch was removed after three minutes and the response graded. Since no serious skin reactions were observed, the second patch was removed after one hour and the response graded. Since the observations at this stage indicated that a four-hour exposure was necessary and could be humanely conducted, the third patch was removed four hours after application and the response was graded at the frequency recorded below.
At the end of the exposure period, residual test article was removed using gauze and mineral oil, without altering the existing response or the integrity of the epidermis. The degree of erythema and edema was evaluated at each interval according to Draize technique.
The test was completed using two additional animals with a four hour exposure. The test article was applied to an area (~5cm x 5cm) on the dorsal trunk of each animal and covered with a gauze patch. The patch was loosely held in contact with the skin with a sheet of rubber dam. The trunk of the animal was wrapped with an elastic bandage dressing, which was held in place with non-irritating tape for a four-hour exposure period. At the end of the exposure period, residual test article was removed using gauze and mineral oil, without altering the existing response or the integrity of the epidermis.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Other effects:
No mortality was observed during the study. No clinical signs were recorded during the course of the study.

Any other information on results incl. tables

The following is a summary of the most severe dermal responses observed:

Exposure

Dermal Responses

Comments

3 minute

No erythema and No edema

No other dermal signs observed

60 minute

No erythema and no edema

No other dermal signs observed

4 hour

Very slight erythema and no edema

No other dermal signs observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Daltolac XR 159 was found to be non-irritating to the skin of rabbits according to the EEC Irritation Rating and the GHS Classification was non-corrosive and non-irritating.
Executive summary:

The purpose of this study was to determine the potential irritant and/or corrosive effects of the test articles on the skin of rabbits.

The test article Daltolac XR 159, was initially applied to three sites on the clipped dorsal trunk of one New Zealand White rabbit. The exposure periods were 3 and 60 minutes and 4 hours, respectively. Observations for dermal irritation were recorded for each site immediately after patch removal, 30-60 minutes post-dose and daily through 72 hours. The four-hour site was scored at 24, 48 and 72 hours after unwrap. Grading of irritation was according to the method of Draize. Daltolac XR 159 was found to be non-irritating to the skin of rabbits.