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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:
29 August 2017 thru 1 September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,3,3,3-hexafluoro-2-methoxypropane
Cas Number:
13171-18-1
Molecular formula:
C4-H4-F6-O
IUPAC Name:
1,1,1,3,3,3-hexafluoro-2-methoxypropane
Test material form:
liquid: volatile
Specific details on test material used for the study:
CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing.

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
ANIMALS:
Sex: Female, nulliparous and non-pregnant.
Age: Young adult (12 weeks)
Weight: 2358 - 2651 grams at experimental start
Source: Received from Robinson Services, Inc. on 23 August 2017

HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 20 - 23 deg C and 51 - 70% relative humidity
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 6 days
Food: Envigo Teklad Global High Fiber Rabbit Diet #2031; 150 g/day along with a Premium Timothy Cube
Water: Filtered tap ad libitum

IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml applied to 6 cm2 intact dose site.
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: 6 cm2
- Type of wrap if used: 1 x 1 guaze pad and 3-inch Micropore tape that covered the pad and entire trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 3% soap solution followed by a tap water rinse and a clean paper towel.
- Time after start of exposure: 4 hours.

OBSERVATION TIME POINTS
- 30 to 60 minutes; 24 hours, 48 hours, and 72 hours after patch removal.

SCORING SYSTEM:
- Draize et al. 1944 and Primary Dermal Irritation Index (PDII) as follows; 0 = non irritating; >0 - 2.0 = Slightly irritating; 2.1 - 5.0 = Moderately irritating; >5.0 = Severely irritating.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
The overall Primary Derminal Index (PDII) score = 0.6; slightly irritating.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time.
Executive summary:

In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2500 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time. Therefore, the substance was determined to not meet the criteria for classification as corrosive or irritating to the skin.