Registration Dossier
Registration Dossier
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EC number: 282-162-4 | CAS number: 84100-84-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1988-09-13 to 1988-09-20
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,3,3-trimethyl-3H-indole-5-carboxylic acid
- EC Number:
- 282-162-4
- EC Name:
- 2,3,3-trimethyl-3H-indole-5-carboxylic acid
- Cas Number:
- 84100-84-5
- Molecular formula:
- C12H13NO2
- IUPAC Name:
- 2,3,3-trimethyl-3H-indole-5-carboxylic acid
- Test material form:
- other: Moist presscake, white-faint reddish
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd.
- Weight at study initiation: 2.9-3.1 kg
- Housing: individual cages (type III) stored in separate section in animal room
- Diet (e.g. ad libitum): ssniff K 4; 1 x 100-120 g/animal/day
- Water (e.g. ad libitum): tap water (7 am to 7 pm)
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL (80 mg) - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: physiological NaCl
- Time after start of exposure: 24 h
SCORING SYSTEM: DRAIZE; chamber water (clouding) according to MCDONALD and SHADDUCK
TOOL USED TO ASSESS SCORE: fluorescein treatment for observation of epithelial defects under UV light and white light, modified according to MCDONALD and SHADDUCK
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- Only one animal (D3) showed a swollen conjunctiva one hour after end of application. However, this effect fully reversed within 24 hours after end of application. All other animals had a DRAIZE-Grade of 0.0 in all observed organs during the entire observation period.
Any other information on results incl. tables
OTHER RESULTS OF IN VIVO STUDY
- Irritation parameter: Fluorescein
- Basis: animal: #1, #2, #3
- Time point: 24 h
- Score: 0.0
- Max. score: 4.0
- Irritation parameter: aqueous humour
- Basis: animal: #1, #2, #3
- Time point: 24/48/72 h
- Score: 0.0
- Max. score: 3.0
- Irritation parameter: Lacrimation
- Basis: animal: #1, #2, #3
- Time point: 24/48/72 h
- Score: 0.0
- Max. score: 3.0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, Trimethylcarbonsäure showed no effects on the eyes.
- Executive summary:
In a primary eye irritation study performed in accordance with OECD Guideline 405 (Acute Eye Irritation / Corrosion), adopted 24 February 1987, Trimethylcarbonsäure was instilled into the conjunctival sac of adult male albino rabbits (strain New Zealand White) for 24 hours and washed with physiological NaCl. Animals then were observed for 7 days. Irritation was scored by the method of DRAIZE and chamber water by the method of MCDONALD and SHADDUCK.
Only in one animal chemosis (DRAIZE grade 1) was observed one hour after end of application. However, this effect fully reversed within 24 hours after end of application. Apart from this single observation, no irritation occurred in any animal during the entire observation period.
In this study, Trimethylcarbonsäure is not an eye irritant.
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