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EC number: 221-359-1 | CAS number: 3077-12-1
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:
- 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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-[(4-methylphenyl)imino]bisethanol
- EC Number:
- 221-359-1
- EC Name:
- 2,2'-[(4-methylphenyl)imino]bisethanol
- Cas Number:
- 3077-12-1
- Molecular formula:
- C11H17NO2
- IUPAC Name:
- 2,2'-[(4-methylphenyl)imino]diethanol
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Germany
- Weight at study initiation: 2.4 kg
- Housing: Animals were individually housed.
- Diet: Mümmel z (ssniff, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 -14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- 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: 0.1 mL - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 8 d
Reading time points: 24, 48 and 72 h and 8 d - Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No washing was performed
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal: #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days in animal #2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days in animal #2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- 24 h after exposure, chemosis (grade 1 or 2) was observed in all animals, which did not disappear in 5/6 animals up to the end of the observation period. The chemosis scores were 1.0 (2/6 animals), 1.3 (1/6 animals), 1.7 (2/6 animals) and 2.0 (1/6 animals) over 24, 48 and 72 h, respectively. All 6 animals showed redness of the conjunctivae (grade 1 or 2), which did not disappear in 5/6 animals up to the end of the observation period. The conjunctivae scores were 1.0 (3/6 animals), 1.7 (2/6 animals) and 2.0 (1/6 animals) over 24, 48 and 72 h, respectively. Adverse effects on the cornea (score 1 or 2) and the iris (score 1 or 2) were observed in all animals, which were not completely reversible up to the end of the observation period. The cornea opacity score of 1.0 and 1.3 was determined for 5/6 and 1/6 animals over 24, 48 and 72 h, respectively. The iris score was 1.3 for 4/6 animals and 1.0 for 2/6 animals over 24, 48 and 72 h, respectively.
Any other information on results incl. tables
Table 1. Results of eye irritation study
| Rabbit # | Time | conjunctivae | iris | cornea | |
| redness | swelling | ||||
| 1 | 24 h | 1 | 1 | 2 | 1 |
| 48 h | 1 | 1 | 1 | 1 | |
| 72 h | 1 | 1 | 1 | 1 | |
| average 24/48/72 h | 1 | 1 | 1.3 | 1 | |
| 8 days | 0 | 0 | 1 | 1 | |
| 2 | 24 h | 1 | 1 | 2 | 1 |
| 48 h | 1 | 1 | 1 | 1 | |
| 72 h | 1 | 1 | 1 | 1 | |
| average 24/48/72 h | 1 | 1 | 1.3 | 1 | |
| 8 days | 1 | 1 | 1 | 1 | |
| 3 | 24 h | 1 | 2 | 1 | 1 |
| 48 h | 1 | 1 | 1 | 1 | |
| 72 h | 1 | 1 | 1 | 1 | |
| average 24/48/72 h | 1 | 1.3 | 1 | 1 | |
| 8 days | 0 | 1 | 1 | 1 | |
| 4 | 24 h | 2 | 2 | 1 | 1 |
| 48 h | 2 | 2 | 1 | 1 | |
| 72 h | 1 | 1 | 1 | 1 | |
| average 24/48/72 h | 1.7 | 1.7 | 1 | 1 | |
| 8 days | 1 | 1 | 1 | 1 | |
| 5 | 24 h | 2 | 2 | 1 | 1 |
| 48 h | 2 | 2 | 1 | 1 | |
| 72 h | 1 | 1 | 1 | 1 | |
| average 24/48/72 h | 1.7 | 1.7 | 1 | 1 | |
| 8 days | 1 | 1 | 1 | 1 | |
| 6 | 24 h | 2 | 2 | 1 | 2 |
| 48 h | 2 | 2 | 1 | 1 | |
| 72 h | 2 | 2 | 1 | 1 | |
| average 24/48/72 h | 2 | 2 | 1 | 1.3 | |
| 8 days | 1 | 1 | 1 | 1 | |
| Time [h] | conjunctivae | iris | cornea | ||
| redness | swelling | ||||
| Mean of 6 animals | 24 | 1.5 | 1.67 | 1.33 | 1.17 |
| 48 | 1.5 | 1.5 | 1 | 1 | |
| 72 | 1.17 | 1.17 | 1 | 1 | |
| 24+48+72 | 1.39 | 1.44 | 1.11 | 1.06 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1, H318 according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The observation period in the conducted study was shorter than recommended in the recent OECD 405. Since the observed effects were not completely reversible up to the end of the observation period of 8 days, the test substance was considered to have a corrosive potential towards the eyes.
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