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Registration Dossier
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EC number: 217-639-8 | CAS number: 1918-77-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: following the Journal Officiel de la République Française of 21/1/71 and 8/6/73
- Principles of method if other than guideline:
- The method is similar to OECD guidelines
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-thienylacetic acid
- EC Number:
- 217-639-8
- EC Name:
- 2-thienylacetic acid
- Cas Number:
- 1918-77-0
- Molecular formula:
- C6H6O2S
- IUPAC Name:
- 2-(thiophen-2-yl)acetic 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: no data
- Age at study initiation: no data
- Weight at study initiation: about 2.5 kg
- Housing: kept in individual in cages measuring 540x360x315 mm or in restraining devices.
- Diet: 150 g per animal per day
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: minimum 20 °C
- Humidity: no data
- Air changes: 12 times per hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: treatment on 24 December 1981
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize's method
TOOL USED TO ASSESS SCORE: naked eye and ophtalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- see table below
Any other information on results incl. tables
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae | Chemosis |
| Max. score: | 4 | 2 | 3 | 4 |
| 60 min | 4/4/4/4/4/4 | 1/ ?/?/1/1/1 | 1/1/1/1/1/1 | 3/3/4/4/4/4 |
| 24 h | 4/4/4/4/4/4 | 1/?/?/?/?/? | 1/X/1/2/2/2 | 4/4/4/4/4/4 |
| 48 h | 4/4/4/4/4/4 | 1/?/?/1/1/1 | 2/2/2/2/3/3 | 4/4/4/4/4/4 |
| 72 h | 4/4/4/4/4/4 | 1/?/?/1/1/1 | 2/2/2/2/3/3 | 4/4/4/4/4/4 |
| Day 4 | 4/4/4/4/4/4 | 2/2/2/2/2/2 | 2/2/2/3/3/3 | 4/4/4/4/4/4 |
| Day 7 | 4/4/4/4/4/4 | 2/2/2/1/2/2 | 3/3/3/3/3/3 | 4/4/4/4/4/4 |
| Average 24-28-72 h | 4 | 1 | 2.1 | 4 |
| Reversibility | no | no | no | no |
| Average time for reversion | / | / | / | / |
?: the degree of the corneal opacity did not allow to observe precisely the iris.
X: reading impossible due to an important effect on chemosis
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study in rabbits, the substance is considered as severely irritant to the eyes.
- Executive summary:
In a primary eye irritation study, 100 mg of undiluted thienyl-2 acetic acid was instilled into the conjunctival sac of the right eye of New Zealand White rabbits 6 males) for 4 hours. The eyes were not washed and animals then were observed for 48 hours. Irritation was scored by the method of Draize.
Mean scores (24-48-72 hours):
- Cornea opacity: 4
- Iris: 2
- Conjunctivae: 3
- Chemosis: 4
In this study, thienyl-2 acetic acid is severely irritating to the eye in rabbits.
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