1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Remarks:

No deviations ocurred during the study that impacted the results.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Novec 7300

IUPAC Name:

Novec 7300

Details on test material:

- Name of test material (as cited in study report): Novec 7300
- Physical state: Colorless, clear liquid
- Analytical purity: 99.85%

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
3M Company, Batch 41-2601-2240-7
- Expiration date of the lot/batch:
23 March, 2006
- Purity test date:
10 June, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
None, applied neat.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: 6 weeks old
- Weight at study initiation: at least 1 kg
- Housing: Individually in labeled cages with perforated floors
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance diet for Rabbits), approximately 100 g per day.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3-21.7 C
- Humidity (%): 25-74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 April, 2005 To: 05 May, 2005

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

After instillation, the eyelids were gently held together for 1 second to prevent loss of the test substance.

Observation period (in vivo):

The eyes of each animals were examined at 1, 24, 48 and 72 hours after instillation.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 2 days

Other effects:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the test article is considered non-irritating to the eye.

Executive summary:

The eye irritation potential of the test material was evaluated in New Zealand White rabbits. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No 405 (2002); EC Directive 67/548/EEC, An. V, B.5 (2004); OPPTS 870.2400 (1998); JMAFF guidelines (2000). Single samples of 0.1 ml of the test article (liquid - dosed undiluted) were instilled into one eye of each of three rabbits. Observations were made at 1, 24, 48, and 72 hours after instillation. Conjunctival redness (Grade 1) was observed in all animals at 1 hour, and persisted in a single animal at 24 hours. No other scores were observed at any other time point. Based on the results of the study, the test article is considered non-irritating to the eye.