Alkyl iodides, C8-14, γ-ω-perfluoro

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1984-07-03 to 1984-07-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD 405, OECD 1981

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkyl iodides, C8-14, γ-ω-perfluoro

EC Number:

289-100-5

EC Name:

Alkyl iodides, C8-14, γ-ω-perfluoro

Cas Number:

85995-91-1

Molecular formula:

CnF2(n-2)+1H4I

Details on test material:

- Name of test material (as cited in study report): Fluower EI, code 06HLAB 005
- Molecular formula (if other than submission substance): n/a
- Molecular weight (if other than submission substance): about 560
- Chemical name: 2-Perfluoralkylethyljodid
- Physical state: light yellow, compact compound
- Analytical purity: 99% Rf-CH2-CH2-J, 1 % inert ingredients and catalyser surpluses
- Impurities (identity and concentrations): n/a
- Composition of test material, percentage of components: n/a
- Purity test date: n/a
- Lot/batch No.: E06 400 406
- Expiration date of the lot/batch: n/a
- Stability under test conditions: n/a
- Storage condition of test material: in the dark at about 20°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: n/a
- Weight at study initiation: 2.9 to 3.3 kg
- Fasting period before study: n/a
- Housing: single, in cages
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2°C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

Eyes were rinsed 24 hours after application.

Observation period (in vivo):

1h, 24h, 48h and 72 h after application

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48 and 72 h after application

Score:

0

Max. score:

0

Remarks on result:

other: none

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48 and 72 h after application

Score:

0

Max. score:

0

Remarks on result:

other: none

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

#1, #2, #3

Time point:

other: 24h, 48h and 72h after application of test substance

Score:

0.33

Max. score:

1

Remarks on result:

other: none

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: 24h, 48h and 72 h after application of test substance

Score:

0

Max. score:

0

Remarks on result:

other: none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test the test substance is considered to be "not irritant" to the rabbit eye.

Executive summary:

The acute eye irritating potential of the test item was investigated in three New Zealand White rabbits. The test item was applied by instillation of 100 mg of the undiluted test substance into the left eye of each of three rabbits. Irritation effects were scored approximately 1h, 24 h, 48 h and 72h after test item instillation. 24 hours after instillation the eyes were rinsed with warm physiological saline solution.

The mean score was calculated across 3 scoring times (24h, 48h and 72h after instillation) for each animal. The individual mean scores for corneal opacity and changes of the iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.00 and 0.66 for reddening and 0.00 for chemosis for all three animals. Based on the results of this test the test substance has not to be classified.