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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:
1984-01 to 1984-04-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period limited to 7 days, in spite of slight conjunctival redness + discharge on day 7; animal room temperature slightly low (16°C); purity of test material not reported.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid
EC Number:
614-283-9
Cas Number:
68127-59-3
Molecular formula:
C9H10ClF3O2
IUPAC Name:
reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid
Details on test material:
- Physical state: crystalline powder
- Colour: white
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported

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: 11 - 17 weeks
- Weight at study initiation: 2.76 - 3.61 kg
- Housing: individually in satinised aluminium sheet cages, 605 x 490 x 455 mm; floor: perforated aluminium sheet, door: Makrolon (polycarbonate)
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 16°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): approx. 100 mg solid test substance / test eye (left eye)
- Application into the conjunctival sac of the left eye
- Concentration (if solution): not applicable

VEHICLE
- none
Duration of treatment / exposure:
- Lids of treated eye gently held together for 1-2 seconds
- 3 / 9 animals: irrigation of treated eye after 20 - 30 seconds
Observation period (in vivo):
1 - 2 hours, 1, 2, 3, 4, and 7 days after application
Number of animals or in vitro replicates:
9 male rabbits, thereof 3 with eye irrigation shortly after application

Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals: washing with 200 mL clean lukewarm water
- Time after start of exposure: 20 - 30 seconds after application of test substance
- No washing in 6 animals

SCORING SYSTEM:
- Draize scale for scoring ocular lesions:
Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics, Association of Food and Drug Officials of the US, 46.
- Interpretation / classification of numerical scores:
Kay JH & Calandra JC (1962) J. Soc. Cosmet. Chem. 13: 6 (modified, as documented in appendix 6 of the study)

TOOL USED TO ASSESS SCORE: none reported

INITIAL PAIN REACTION:
- Assessed immediately after application
- Scale 0 - 5 points, depending on observed reactions, according to descriptions shown in appendix 4 of report

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: animal 15
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
iris score
Basis:
other: animal 15
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
conjunctivae score
Basis:
other: animal 15
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: without irrigation; reported as redness
Irritation parameter:
chemosis score
Basis:
other: animal 15
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
cornea opacity score
Basis:
other: animal 16
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
iris score
Basis:
other: animal 16
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
conjunctivae score
Basis:
other: animal 16
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: without irrigation; reported as redness
Irritation parameter:
chemosis score
Basis:
other: animal 16
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
cornea opacity score
Basis:
other: animal 17
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
iris score
Basis:
other: animal 17
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritation parameter:
conjunctivae score
Basis:
other: animal 17
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: without irrigation; reported as redness
Irritation parameter:
chemosis score
Basis:
other: animal 17
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: without irrigation
Irritant / corrosive response data:
Slight iritis and slight corneal opacity were observed in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.
Other effects:
Initial pain reaction: practically none to moderate (classes 1-3 on a 0-5 scale)
Slight mucoid discharge and slight Harderian discharge on day 3 in one animal each

Any other information on results incl. tables

One animal in the non-irrigated group became sick and had to be killed on day 6 after the application; it still showed conjunctival discharge. Another one (with irrigated eye) was found dead on day 3, with slight redness, chemosis, and discharge. The author does not attribute the deaths to effects of the test material.

Table 1: Data for individual animals without irrigation:

Animal Sex Elapsed Cornea Iris Conjunctiva Total
no time Opacity Area Score Score Redness Chemosis Discharge Score Score
(A) (B) (AxBx5) (C) (Cx5) (D) (E) (F) (D+E+F)x2
15 M 1.4 hrs 0 0 0 1 5 2 2 3 14 19
1 day 1 1 5 0 0 2 2 1 10 15
2 days 1 1 5 0 0 2 1 1 8 13
3 days 0 0 0 0 0 2 1 1 8 8
4 days 0 0 0 0 0 1 1 1 6 6
7 days 0 0 0 0 0 0 0 0 0 0
16 M 1.5 hrs 0 0 0 0 0 2 2 3 14 14
1 day 1 1 5 0 0 2 2 2 12 17
2 days 0 0 0 0 0 1 1 1 6 6
3 days 0 0 0 0 0 0 0 0 0 0
4 days 0 0 0 0 0 0 0 0 0 0
7 days 0 0 0 0 0 0 0 1 2 2
17 M 1.4 hrs 0 0 0 1 5 2 2 3 14 19
1 day 0 0 0 0 0 2 2 1 10 10
2 days 0 0 0 0 0 1 0 1 4 4
3 days 0 0 0 0 0 1 0 1 4 4
4 days 0 0 0 0 0 1 0 1 4 4
6 days 0 0 0 0 0 0 0 1 2 2
6 days 0 0 0 0 0 0 0 1 2 2
18 M 1.4 hrs 1 1 5 1 5 2 2 3 14 24
1 day 1 1 5 0 0 2 1 2 10 15
2 days 1 1 5 0 0 2 1 2 10 15
3 days 0 0 0 0 0 1 1 1 6 6
4 days 0 0 0 0 0 1 1 1 6 6
7 days 0 0 0 0 0 1 0 1 4 4
19 M 1.4 hrs 0 0 0 0 0 2 2 3 14 14
1 day 0 0 0 0 0 2 2 2 12 12
2 days 0 0 0 0 0 1 1 1 6 6
3 days 0 0 0 0 0 1 0 1 4 4
4 days 0 0 0 0 0 1 0 1 4 4
7 days 0 0 0 0 0 1 0 0 2 2
20 M 1.4 hrs 0 0 0 0 0 2 2 3 14 14
1 day 1 1 5 0 0 2 2 1 10 15
2 days 0 0 0 0 0 2 1 1 8 8
3 days 0 0 0 0 0 2 1 1 8 8
4 days 0 0 0 0 0 1 1 0 1 4
7 days 0 0 0 0 0 1 0 0 2 2

Table 2: Data for individual animals with irrigation:

Animal Sex Elapsed Cornea Iris Conjunctiva Total
no time Opacity Area Score Score Redness Chemosis Discharge Score Score
(A) (B) (AxBx5) (C) (Cx5) (D) (E) (F) (D+E+F)x2
12 M 1.3 hrs 0 0 0 0 0 2 1 1 8 8
1 day 0 0 0 0 0 1 1 0 4 4
2 days 0 0 0 0 0 1 0 0 2 2
3 days 0 0 0 0 0 0 0 0 0 0
4 days 0 0 0 0 0 0 0 0 0 0
1 days 0 0 0 0 0 0 0 0 0 0
13 M 1.5 hrs 0 0 0 0 0 2 2 2 12 12
1 day 0 0 0 0 0 1 1 0 4 4
2 days 0 0 0 0 0 1 1 0 4 4
3 days 0 0 0 0 0 1 0 0 2 2
4 days 0 0 0 0 0 1 0 0 2 2
7 days 0 0 0 0 0 0 0 0 0 0
14 M 1.4 hrs 0 0 0 0 0 2 2 2 12 12
1 day 0 0 0 0 0 1 1 0 4 4
2 days 0 0 0 0 0 1 1 1 6 6

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritant potential of the test substance to the rabbit eye was found to be moderate (class 5 on a 1-8 scale) without irrigation, and mild (class 4) after irrigation. The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.
Executive summary:

The acute eye irritation potential of the test material (a powder) was assessed according a method similar to OECD 405 in nine male New Zealand White rabbits. The test substance (0.1 g) was applied directly into the conjunctival sac of the left eye of the animals; the right eye served as control. The eyes of three rabbits were irrigated with 200 mL of lukewarm water 20-30 seconds after the application. The ocular reactions were assessed at the following time points: 1-2 hours, 1, 2, 3, 4, and 7 days post application, according to the Draize scale.

Practically none to moderate initial pain was observed immediately after the application of the test substance.

Slight iritis and slight corneal opacity were recorded in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.