Propane, 1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 February 2005 to 18 August 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)propane

EC Number:

609-534-4

Cas Number:

382-26-3

Molecular formula:

C5H4F8O

IUPAC Name:

1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)propane

Details on test material:

- Name of test material (as cited in study report): Octafluoro isobutyl methyl ether
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: > 86%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: n.a.
- Purity test date: not reported
- Lot/batch No.: 161 - (20/01/04)
- Expiration date of the lot/batch: 2006
- Stability under test conditions: not reported
- Storage condition of test material: in the refrigerator (range 5 +- 3°C), light protected

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, undiluted

Duration of treatment / exposure:

one single instillation (0.1 mL/animal)

Observation period (in vivo):

10 days

Number of animals or in vitro replicates:

3 (Animals of both sexes were used: 1 male + 2 females)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 3

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 11

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Viability

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Irritation

The mean score was calculated across 3 scoring times mean (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.

Very slight corneal opacity affecting the whole area was noted in all animals at the 24 -hour observation and persisted in one female animal up to the 72 -hour reading.

Moderate reddening of the conjunctivae was noted in all animals from the 1 -hour to the 24 -hour observation and persisted in one female animal up to the 72-hour reading . Slight reddening was noted in two animals at the 48 -hour reading and was still present at the 72 -hour observation in the male animal.

Slight swelling (chemosis) of the conjunctivae was observed in all animals at the 1 -hour reading. Slight swelling to obvious swelling with partial eversion of lids was noted in all animals at the 24 -hour reading and slight swelling persisted in one female up to the 72 -hour reading.

Moderate reddening of the sclerae was present in all animals at the 1 -hour reading. Slight to moderate reddening was noted in all animals at the 24 -hour reading and in two animals at the 48 -hour reading. Slight erddening was noted in all animals at the 72 -hour reading and persisted in one animal up to the 7 -day reading.

Slight ocular discharge was noted in all animals from the 1 -hour to the 24 -hour observation.

Coloration

No staining of the treated eyes produced by the test item was observed.

Corrosion

No corrosion of the cornea was observed at any of the reading times.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane is considered to be "not irritanting" to the rabbit eye.

Executive summary:

The primary eye irritation potential of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1ml into the left eye of three young adult New Zeland White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 and 10 days after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean score were 0.33, 0.33 and 0.00 for corneal opacity and 0.00 for the iris for all three animals, respectively. The individual mean scores for the conjunctivae were 1.33, 2.00 and 1.00 for redness and 0.33, 1.33 and 0.33 for chemosis, respectively.

The instillation of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane into the eye resulted in moderate, early onset and transient ocular changes, such as corneal opacity, reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 10 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus the test item does not induce significant or irreversible damage to the rabbit eye.