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Diss Factsheets

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:
December 18, 2017-January 2, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Originally, the test was carried out for the purpose of another regulation- Registration in the US- according to TSCA US EPA OPPTS 870.2500, Acute dermal irritation.
[EPA 712-C-98-196].

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
Cas Number:
2230512-72-6
Molecular formula:
C7H17O3P
IUPAC Name:
Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
Test material form:
liquid
Details on test material:
R&D level
Specific details on test material used for the study:
Composition: 100%
Physical description: Clear transparent liquid
Stability: Test substance was expected to be stable for the duration of the study
Expiration date: November 3, 2020

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or test system and environmental conditions:
Number of animals: 3
Sex: Female, nulliparous and non-pregnant
Species/strain: Rabitt/New Zealand albino
Age/body weight: Young adults (13-14 weeks)/ 2641-2976 gr at experimental start
Source: Received from Robinson Services Inc. on Nov 15 and Dec. 13, 2017
Housing: The animals were singly housed in suspended stainless steel caging which
conforms to the size recommendations in the most recent Guide for the Care and Use
of Laboratory Animals (Natl. Res. Council, 20 11). Enrichment (e.g., toy) was placed
in each cage. Litter paper was placed beneath the cage and was changed at least three
times per week.
Animal Room Temperature and Relative Humidity Ranges: 19-23"C and 42-53%,
respectively.
Animal Room Air Changes/Hour: 13. Airflow measurements are evaluated regularly
and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 13 or 33 days
Food: Envigo Teklad Global High Fiber Rabbit Diet® #2031. A designated amount
of the diet (approximately 150 grams/day) and a Premium Timothy Cube™ (Ontario
Dehy Inc.) were available to each rabbit.
Water: Filtered tap water was supplied ad libitum.
Contaminants: There were no known contaminants reasonably expected to be found
in the food or water at levels which would have interfered with the results of this
study. Analyses of the food and water are conducted regularly and the records are
kept on file at Product Safety Labs

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Five-tenths of a mililiter of the material was applied to the skin of each dose.
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
30-60 min after patch removal after the appropriate patch removal and subsequent evaluations were performed approx. 24, 48, 72 hr after removal of the four-hour patch.
Number of animals:
3
Details on study design:
PROCEDURE
Preparation and selection of animals: On the day before application, a group of animals was prepared by clipping the dorsal area of the trunk.
On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healty, naive animals (not previously tested) without pre-existing skin irritation were selected for test. Initially, only one rabbit was placed on test. Since no significant dermal irritation was observed at the dose sites on this animal, the test was completed with two additional rabbits.
Preparation of test substance: The test substance was applied and mixed well prior to use. The pH was determined for the test substance prior to the application and was within the pH range of 2 and 11.5., therefore testing proceeded. The procedure used and the results are retained in the raw data.
Application of test substance: Initial testing was conducted on one rabbit to determine the irritation/corrosion potential of the test substance. Three dose site, each approximately 6-cm2, were delieated on this raddit. Five-tenths of a mililiter of the test substance was applied to the skin of each dose site and covered with 1-inch x 1-inch, 4-ply qauze pad. The pads and entire trunk of animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the patches. An Elizabethan collar was placed on the rabbit after removal of the 3-minute patch and it was returned to its designated cage. The pads were removed at the appropriate intervals (3 minutes, 1 hour and 4 hours). All dose sites were evaluated for corrosion 30-60 minutes after patch removal. Subsequent evaluations were performed approximately 24, 48, 72 hours after removal of the four hour patch. Since there was no corrosion observed at any of the dose sites for this animal, two additional rabbits (each with one patch only for a 4- hour exposure period), were selected for further testing and treated in the same manner as described above with an additional evaluation at 7 days.
After the 3-minute and 1-hour exposure periods, the pads were removed and the dose sites were cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
After the 4-hour exposure period, the pads and collars were removed and the dose sites were cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
Evaluation of dose sites: indevidual dose sites were scored according to the Draize scoring system at approximately 30-60 minutes, 24, 48 and 72 hours and/or 7 days after patch removal in addition to evaluation for corrosion at these intervals for the first animal only.
The classification of irritancy was obtained by adding the average erythema and edema scores for the 30-60 minute, 24, 48 and 72-hour scoring and dividing by the number of evaluation intervals.
the resulting Primary Dermal Irritation Index (PDII) was classified as follows:
PDII Classification
0 Non-irritating
>0-2.0 Slightly irritating
2.1-5.0 Moderately irritating
> 5.0 Severly irritaiting

Cage side Observations: The animals were observed for signs of gross toxicity and behavioral changs at least once daily during the test period.
Body weights: Individual weights of animals were recorded shortly before application of the test substance (initial) and at the completion of testing (terminal).
Study termination: Once testing was complete, the animals were released for euthanasia and humanely euthanized.
Statistical analysis was limited to the calculation of the mean irritation score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: PDI for 30-60 min, 24, 48 and 72 hr
Score:
ca. 0.7
Reversibility:
other: Edema within 24 hr, Erythema within 7 days
Remarks on result:
other: slightly irritating
Irritation parameter:
erythema score
Remarks:
3 minute exposre
Basis:
animal #1
Time point:
other: 30-60 min after patch removal
Score:
1
Irritation parameter:
erythema score
Remarks:
3 minute exposure
Basis:
animal #1
Remarks:
time after removal 4 hr patch
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
erythema score
Remarks:
1 hr exposure
Basis:
animal #2
Time point:
other: 30-60 min after patch removal
Score:
0
Irritation parameter:
erythema score
Remarks:
1 hr exposure
Basis:
animal #2
Remarks:
time after removal 4 hr patch
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #3
Time point:
other: 30-60 min after patch removal
Score:
1
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #4
Time point:
other: 30-60 min after patch removal
Score:
1
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #4
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not fully reversible within: 48 hr
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #4
Time point:
other: 72 hr / 7 d
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #5
Time point:
other: 30-60 min after patch removal
Score:
1
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
erythema score
Remarks:
4 hr exposure
Basis:
animal #5
Time point:
7 d
Score:
0
Irritation parameter:
edema score
Remarks:
3 minutes exposure
Basis:
animal #1
Time point:
other: 30-60 min after patch removal
Score:
0
Irritation parameter:
edema score
Remarks:
3 minute exposure
Basis:
animal #1
Remarks:
time after removal of 4 hr patch
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
animal #2
Time point:
other: 30-60 min after patch removal
Score:
0
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
animal #2
Remarks:
time after removal of 4 hr patch
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #3
Time point:
other: 30-60 min after patch removal
Score:
1
Irritation parameter:
edema score
Remarks:
4 hr exposure
Basis:
animal #3
Remarks:
time after patch removal
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #4
Remarks:
time after patch removal
Time point:
other: 30-60 min
Score:
1
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #4
Remarks:
time after patch removal
Time point:
other: 24/48/72 hr and 7 d
Score:
0
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #5
Remarks:
time after patch removal
Time point:
other: 30-60 min, 24 hr / 48 hr / 72 hr / 7 d
Score:
0
Irritant / corrosive response data:
No visible necrosis (corrosion) of the skin tissue was observed at the 3-minute, 1-hour and 4-hour dose sites during the study.
Other effects:
All animals appeared active and healty and gained body weight during the study. There were no other signs of gross toxicity, adverse clinical effects, or abnormal behavior.

Any other information on results incl. tables

3 -minute exposure site:

Very slight erythema was observed at the dose site within 30 -60 minutes after patch removal, which resolved by 24 hours for the first animal.

1 -hour exposure site:

No dermal irritation was noted at the 1 -hour exposure site for the first animal

4 -hour exposure site:

Within 30 -60 minutes of patch removal, all three treated sites exhibited very slight erythema and/or very slight edema. The overall incidence and severity of irritation decreased gradually with time. All animals were free of dermal irritation by day 7 (study termination)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary Dermal Index for this substance is 0.7.
Under the conditions of the study, E17-194T is slightly irriating to skin.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for E17 -194T to produce irritation after a single topical application.

initially one rabbit was tested, to determine the irritation/corrosion of the test substance. Three dose sites, each approx. 6 -cm2, were delineated on this animal. 5/10 of a mililiter were applied to the skin of each dose site. The pads and entire trunk of the animal were wrapped with semi occlusive 3 -inch Micropore tape. The patches were removed at the appropriate intervals (3 min, 1hr and 4 hr). All dose sites were evaluated according to Draize method of scoring.

Results: The primary Dermal Index for this substance is 0.7. Under the conditions of the study, E17-194T is  slightly irriating to skin.