Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study OECD 405, OECD 1981. Due to ECHA practical guide No.6 "How to report read-across and categories" section 4, paragraph 4.1 and although this study report is a Klim 1 report it has to be validated as reliability 2 because being used for read across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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
- Purity test date: n/a
- 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

Resultsopen allclose all
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
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
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
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: none
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.