Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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 870.2400 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
ANIMALS:
Sex: Female, nulliparous and non-pregnant.
Age: Young adult (12 weeks)
Weight: 2400 - 2741 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 68 - 74% 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

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: N/A

SCORING SYSTEM: Draize et. al. 1994.

TOOL USED TO ASSESS SCORE: White light source and fluorescein dye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was only slightly irritating in 1 test animal at the 1 hour observation time. This response cleared up by the 24 hour observation time. There were no signs of irritation at the 24, 48, or 72 hour observation times in any of the test animals.
Executive summary:

In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2400 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 1 of 3 animals at the 1-hour observation mark. No signs of irritation remained at the 24 hour observation time and there were no signs of irritation in any of the test animals at the 24, 48, or 72 hour observation times. Therefore, the substance was determined to not meet the criteria for classification as damaging or irritating to the eye.