(S,S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane;reaction mass of: (R,R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Eye irritation

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:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect dated 2002.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

420-640-8

EC Name:

-

Cas Number:

138495-42-8

Molecular formula:

C5H2F10

IUPAC Name:

(3R,4R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane; (3S,4S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Details on test material:

-Purity: 97.6%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3260-3348 g
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 g rabbit chow daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye of each rabbit was not treated and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

1, 24, 48, 72 hours following administration

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes remained unwashed.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: Illumination, magnification, and biomicroscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0

Max. score:

0

Results 4

Irritation parameter:

other: biomicroscope

Basis:

other: range

Time point:

other: 24 hours to 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

The test substance produced conjunctival redness in 1 rabbit.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects
	Rabbit No.	Cornea		Iritis	Conjunctiva			Biomic
		Opacity	Area		Redness	Chemosis	Discharge
1 Hour	27898	0	0	0	0	0	0	-
	27861	0	0	0	1	0	0	-
	27848	0	0	0	0	0	0	-
24 Hours	27898	0	0	0	0	0	0	0
	27861	0	0	0	1	0	0	0
	27848	0	0	0	0	0	0	0
48 Hours	27898	0	0	0	0	0	0	0
	27861	0	0	0	0	0	0	0
	27848	0	0	0	0	0	0	0
72 Hours	27898	0	0	0	0	0	0	0
	27861	0	0	0	0	0	0	0
	27848	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EEC Directive 91/325

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). The overall conjunctival chemosis, conjunctival redness, iritis, and corneal opacity scores were 0, 0.11, 0, and 0, respectively.

Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of approximately 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration. Under the conditions of the study, the test substance produced conjunctival redness in 1 rabbit. Mean values were calculated from the quantitative evaluation of ocular lesions observed in all rabbits at 24, 48, and 72 hours following administration. The overall conjunctival chemosis, conjunctival redness, iritis, and corneal opacity scores were 0, 0.11, 0, and 0, respectively.