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EC number: 700-093-4 | CAS number: 176969-34-9
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jul - 04 Aug 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2020
- Deviations:
- yes
- Remarks:
- no analgesic applied prior to, during or after test item instillation
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted in 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Gesundheit und Soziales, Düsseldorf, Germany
Test material
- Reference substance name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
- EC Number:
- 700-093-4
- Cas Number:
- 176969-34-9
- Molecular formula:
- C6H6F2N2O2
- IUPAC Name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (Rettenmaier & Söhne GmbH & Co, Rosenberg, Germany)
- Diet: Ssniff K-Z 4mm (Ssniff Spezialdiäten GmbH, Soest, Germany), approximately 100 g per animal per day
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 hours and Day 7 - Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eye was rinsed 24 h after test item instillation
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour following test substance instillation, the test compound adhered to cornea and conjunctivae. The test item caused conjunctival redness and chemosis in all 3 animals. Scores for conjunctival redness were 2/2/1/1 in 2/3 animals and 2/2/2/2 in 1/3 animals 1, 24, 48 and 72 h after instillation. Scores for conjunctival chemosis were 2/1/0/0 in 1/3 animals, 2/2/0/0 in 1/3 animals and 1/2/2/1 in 1/3 animals 1, 24, 48 and 72 h after instillation. All effects were fully reversible by study Day 7.
- Other effects:
- No clinical signs of systemic toxicity were observed.
Any other information on results incl. tables
Table 1: Eye irritation effects
| Animal No. 1 | ||||||||
| Observation | 1 h | 24 h | 48 h | 72 h | Day 7 | Day 14 | Day 21 | Score 24/48/72 h |
| Degree of corneal opacity | 0 | 0 | 0 | 0 | 0 | - | - | 0 |
| Area of corneal opacity | 0 | 0 | 0 | 0 | 0 | - | - | |
| Iris | 0 | 0 | 0 | 0 | 0 | - | - | 0 |
| Conjunctival redness | 2 | 2 | 1 | 1 | 0 | - | - | 1.33 |
| Conjunctival chemosis | 2 | 1 | 0 | 0 | 0 | - | - | 0.33 |
| Animal No. 2 | ||||||||
| Observation | 1 h | 24 h | 48 h | 72 h | Day 7 | Day 14 | Day 21 | |
| Degree of corneal opacity | 0 | 0 | 0 | 0 | 0 | - | - | 0 |
| Area of corneal opacity | 0 | 0 | 0 | 0 | 0 | - | - | |
| Iris | 0 | 0 | 0 | 0 | 0 | - | - | 0 |
| Conjunctival redness | 2 | 2 | 1 | 1 | 0 | - | - | 1.33 |
| Conjunctival chemosis | 2 | 2 | 0 | 0 | 0 | - | - | 0.67 |
| Animal No. 3 | ||||||||
| Observation | 1 h | 24 h | 48 h | 72 h | Day 7 | Day 14 | Day 21 | |
| Degree of corneal opacity | 0 | 0 | 0 | 0 | 0 | - | - | 0 |
| Area of corneal opacity | 0 | 0 | 0 | 0 | 0 | - | - | |
| Iris | 0 | 0 | 0 | 0 | 0 | - | - | 0 |
| Conjunctival redness | 2 | 2 | 2 | 2 | 0 | - | - | 2.00 |
| Conjunctival chemosis | 1 | 2 | 2 | 1 | 0 | - | - | 1.67 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The substance was tested for eye irritation/ corrosion according to OECD guideline 405. For the treated eyes of all 3 rabbits used in the test, conjunctival redness and chemosis were noticed, with the effects being reversible within 7 days. However, Draize scoring values remained below the limits for classification, and thus, the substance is considered not to be an eye irritant.
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