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EC number: 212-298-1 | CAS number: 778-94-9
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 - 26 Oct 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 14 Jun 2021
- Deviations:
- yes
- Remarks:
- No topical anesthetics and systemic analgesics were used.
- GLP compliance:
- yes
- Remarks:
- The test complied with the Principles of Good Laboratory Practices (GLP) of the Certification and Accreditation Administration of the People’s Republic of China (2013 revised edition).
Test material
- Reference substance name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
- EC Number:
- 212-298-1
- EC Name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
- Cas Number:
- 778-94-9
- Molecular formula:
- C8H3F3N2O2
- IUPAC Name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese long-eared white rabbit, general grade
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Co., Ltd., Shandong, China
- Age at study initiation: not reported
- Weight at study initiation: 1.70 - 1.85 kg (males)
- Fasting period before study: not reported
- Housing: individually in in hanging stainless steel cages (L38 cm x W50 cm x H35 cm) affixed on rearing shelves (L200 cm x W65 cm x H170 cm)
- Diet: rabbit maintenance feed (Liaoning Changsheng Biotechnology Co., Ltd, Liaoning, China); ad libitum
- Water: grade-one reverse osmosis water (Liaoning Changsheng Biotechnology Co., Ltd, Liaoning, China); ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.10 - 24.00
- Humidity (%): 40.20 - 70.00
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: 07 - 26 Oct 2019
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g ground test sample
- Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 16 days
Reading time points: 1 h, 24 h, 48 h, 72 h, and 4 - 16 d - Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- PRE- / POST-TREATMENT OF THE ANIMALS:
No topical anaesthetics and stystemic analgesics were administered prior to nor after test substance application.
REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: Draize scoring system.
TOOL USED TO ASSESS SCORE: fluorescein
Approximately 24 h before the test started, a headlight magnifier and 2% sodium fluorescein (vehicle: normal saline) were used to examine the exterior, conjunctiva, cornea, and iris of both eyes of the animals. Approximately 1 hour, 24 hours, 48 hours, 72 hours, and 4 - 16 days after the test sample was applied, a headlight magnifier was used to examine both eyes of the test animals. In addition, at observation points approximately 24 hours, 48 hours, 72 hours, 4 - 7 days, and 14 days after the test sample was applied, a fluorescein examination was carried out on both eyes of the test animals.
Fluorescein staining examination method: One drop of 2% sodium fluorescein normal saline solution was dripped into the conjunctival sac of the eye. After 15 sec, normal saline was used to gently rinse the eye, and the headlight magnifier was used to examine whether the cornea had retained the fluorescein.
At the pre-test eye examination, no eye irritation, ocular defects, or corneal damage were visible in the eyes of the test animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 12 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 12 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 d
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- After test substance application severe effects on the eyes (iritis, chemosis, conjunctivitis and corneal opacity) occurred starting partly 1 h after test substance application. All observed effects were reversible - latest on day 16 after test material application. For individual and mean ocular scores, see tables 2 and 3 under section "any other information on results incl. tables".
- Other effects:
- Clinical symptoms: All three animals showed clinical symptoms after test item administration. The initial response was closed eyes for all animals. Chemosis and secretions were noted from 1 h after administration, and corneal opacity occurred from 24 h after administration. Symptoms reversed until 16 days after treatment at the latest. For details on clinical symptoms, see table 1 under section "any other information on results incl. tables".
Body weight: All animals gained body weight (0.40 - 0.45 kg) during the test period and had similar weights at the end of the test (2.50 - 2.55 kg).
Fluorescein retention: All three animals exhibited retention of sodium fluorescein at 24 h, 48 h, 72 h and 4 - 7 days after test chemical administration. On the 14th day after administration, the retained sodium fluorescein had disappeared.
Any other information on results incl. tables
Table 1: Table of Clinical Observations
| Animal 1 | Animal 2 | Animal 3 |
Initial response | B | B | B |
1 h | BSF | B1SF | B1SF |
7 h | BSF | B1SF | B1SF |
24 h | B1SFH | B1SFH | B1SFH |
30 h | B1SFH | B1SFH | B1SFH |
48 h | B1SFH | B1SFH | B1SFH |
54 h | B1SFH | B1SFH | B1SFH |
72 h | B1SFH | B1SFH | B1SFH |
78 h | B1SFH | B1SFH | B1SFH |
4 d | B1SFH | B1SFH | B1SFH |
5 d | B1SFH | B1SFH | B1SFH |
6 d | SFH | B1SFH | SFH |
7 d | SFH | SFH | SFH |
8 d | SFH | SFH | SFH |
9 d | SH | SFH | SH |
10 d | SH | SH | SH |
11 d | SH | SH | SH |
12 d | SH | SH | H |
13 d | SH | H | H |
14 d | S | H | H |
15 d | S | H | N |
16 d | N | N | - |
N: no abnormalities; B: closed eyes; S: chemosis; F: secretions; H: corneal opacity; B1: half-closed eyes
Table 2: Table of Individual Eye Response Total Scores
Animal no. | Ocular response | Ocular response total score – observation timepoints | ||||||||||||||||
1 h | 24 h | 48 h | 72 h | 4 d | 5 d | 6 d | 7 d | 8 d | 9 d | 10 d | 11 d | 12 d | 13 d | 14 d | 15 d | 16 d | ||
1 | Cornea | 0 | 3 | 3 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
Iris | 0 | 2 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctival hyperaemia | 1 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 0 | 0 | |
Chemosis | 2 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | |
2 | Cornea | 0 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
Iris | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctival hyperaemia | 1 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | |
Chemosis | 2 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | |
3 | Cornea | 0 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | - |
Iris | 0 | 2 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
Conjunctival hyperaemia | 1 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | - | |
Chemosis | 2 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | - |
Table 3: Individual Eye Response Mean Scores
Animal no. | Ocular response | Individual ocular response – mean score |
1 | Cornea | 2.7 |
Iris | 2 | |
Conjunctival hyperaemia | 3 | |
Chemosis | 3 | |
2 | Cornea | 3 |
Iris | 2 | |
Conjunctival hyperaemia | 3 | |
Chemosis | 3 | |
3 | Cornea | 3 |
Iris | 2 | |
Conjunctival hyperaemia | 3 | |
Chemosis | 3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 "Eye Dam. 1" (H318) according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the present test conditions, the test substance 2-nitro-4-(trifluoromethyl)benzonitrile was corrosive to the eyes of three male rabbits. The mean scores for cornea/iris/conjunctiva hyperaemia/chemosis in the right eye at 24 h, 48 h, and 72 h after test chemical administration were 2.7/2/3/3, 3/2/3/3, and 3/2/3/3 for the three animals, respectively. According to the Regulation (EC) No 1272/2008, the test sample thus meets the criteria for Eye Damage 1 (H318).
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