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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 November 2001 to 19 November 2001 (dates of study plan)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 67/548/EEC, B.5:"Acute Toxicity-Eye Irritation." Official Journal of the European Communities No. L 383, 1992.
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
T-7599
IUPAC Name:
T-7599
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): T-7599
- Physical state: White powder
- Analytical purity: >99.9% 1-Butanesulfonamide, 2, 2, 3, 3, 4, 4, 5, 5, 5-Nonafluoro-n-(2-Hydroxyethyl)-N-Methyl- and <0.1 % Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 07 August 2002
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark

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, Kisslegg, Germany.
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: Body weights were between 1.0 and 3.5 kg.
- Fasting period before study: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 C
- Humidity (%): 30-70%. Temporary deviations due to cleaning procedures but considered not to have an affect on study integrity.
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
IN-LIFE DATES: From: To: 12 November 2001 to 19 November 2001

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye in each animal was treated, the other was left untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 62.1 mg test article (volume of approx. 0.1ml)
Duration of treatment / exposure:
A couple seconds during instillation of the test article.
Observation period (in vivo):
24 hours.
Number of animals or in vitro replicates:
3
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Irritation observed at 1, 24, 48 and 72 hours and 7 days during the observation period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Immediately after the 24 hour observation, 2% flurescein in water (pH 7.0) was instilled in both eyes to measure corneal epithlial damage. Bright green stained area was estimated as a percentage of total corneal area.
Opthamalic examination was perfomed using an examination lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritant / corrosive response data:
Scores for corneal and iris irritation averaged zero in all test animals. Conjunctivae irriation shown by eye redness scored a mean of 1.7 in all test animals. Mean chemosis scores were 0.3, 0.7 and 0.7 for the three test animals, repectively.
Other effects:
Instillation of approximately 62 mg of the test article into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in two animals and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharage, which had completely resolved within 7 days in all animals. No corneal epthelial damage, ocular corrosion, staining of ocular tissues and symptoms of systemic toxicity were not observed in the animals during the test period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, The test article does not have to be classified and has no obligatory labeling requirement for eye iritation.
Executive summary:

An acute eye irritation/corrosion study was done in three New Zealand White albino rabbits (according to OECD 405 and EC Council Directive 67/548/EEC). 62.1 mg of the test substance was instilled in the conjunctival sac of one of the eyes and then washed (24 hours later) with a solution of 2% fluorescein in water) to observe corneal epithelial damage, Eyes of the animals were examined approximately 1, 24, 48, 72 hours and 7 days after the instillation of the test substance. The irritation scores and description of local effects were recorded. All iridial irritation (grade 1 at 1 hour) resolved within 24 hours. Conjunctival irritation causes redness, chemosis and discharged and had completely resolved within 7 days in all animals. No corrosion, staining of ocular tissues, systemic toxicity or mortality were based during the test period. Therefore, the test article does not have to be classified and has no obligatory labelling requirements for eye irritation.