Registration Dossier
Registration Dossier
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EC number: 247-722-4 | CAS number: 26471-62-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
- Reference Type:
- publication
- Title:
- Toxicology, industrial hygiene and medical control of TDI, MDI and PMPPI
- Author:
- Woolrich PF
- Year:
- 1 982
- Bibliographic source:
- Am. Ind. Hyg. Assoc. J. 43 (2): 89-97
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- m-tolylidene diisocyanate
- EC Number:
- 247-722-4
- EC Name:
- m-tolylidene diisocyanate
- Cas Number:
- 26471-62-5
- Molecular formula:
- C9H6N2O2
- IUPAC Name:
- 2,4-diisocyanato-1-methylbenzene, 2,6-diisocyanato-1-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): Toluene Diisocyanate (TDI) (mixed isomers)
- Physical state: clear, slightly viscous, oily liquid
- Analytical purity: considered free of impurities
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1973 - 2956 g
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL, into the conjunctival sac of the right eye of each rabbit. - Duration of treatment / exposure:
- two seconds and four seconds
- Observation period (in vivo):
- Eyes observed at 0.5, 1.5, 4, and 8 h, then daily up to 30 days.
- Number of animals or in vitro replicates:
- 3 per group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Yes. The treated eye of one group of three animals were not washed. The treated eyes of the second group of three animals were washed two seconds after instillation, and the treated eyes of the third group of three animals were washed four second after instillation.
- Time after start of exposure: two and four seconds
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: sodium fluorescein at 2 % and a small-window, ultraviolet, quartz, mercury pencil lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 30 days
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 19 days
- Remarks on result:
- other: unwashed eye
- Irritant / corrosive response data:
- Conjunctival irritation moderate - severe in all groups at 24 hours. Persisted for 10 days in 1st 2 groups but 3rd group less affected at this time.
Cornea and iris also affected. In 2 rabbits, corneal opacity persisted up to 30 days. Classed as moderate - severe eye irritant on Draize scale.
The raw data are tabulated in table 1, 2 and 3 in field "remarks on results including tables and figures".
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (unwashed)
| Score at time point/ Reversibility | Cornea Max. score:4 |
Iris Max. score:2 |
Conjunctivae Max. score:3 |
Chemosis Max. score:4 |
| 24 h | 1/0/1 | 1/0/0 | 3/3/3 | 4/4/4 |
| 48 h | 2/0/0 | 1/0/0 | 3/3/3 | 4/4/4 |
| 72 h | 2/0/0 | 1/0/0 | 3/3/3 | 4/4/4 |
| Average 24 h, 48 h, 72 h | 0.66 | 0.33 | 3 | 4 |
| Reversibility within 21 days*) | n.c. | c. | c. | c. |
*) Reversibility: c.= completely reversible; n.c.= not completely reversible; n.= not reversible
Table 2: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (wash after 2 s)
| Score at time point/ Reversibility | Cornea Max. score:4 |
Iris Max. score:2 |
Conjunctivae Max. score:3 |
Chemosis Max. score:4 |
| 24 h | 1/1/1 | 1/1/1 | 3/3/3 | 4/4/4 |
| 48 h | 1/1/0 | 0/1/1 | 3/3/3 | 4/4/4 |
| 72 h | 0/1/0 | 0/1/0 | 3/3/3 | 4/4/4 |
| Average 24 h, 48 h, 72 h | 0.66 | 0.66 | 3 | 4 |
| Reversibility within 21 days*) | n.c. | c. | c. | c. |
*) Reversibility: c.= completely reversible; n.c.= not completely reversible; n.= not reversible
Table 3: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (wash after 4 s)
| Score at time point/ Reversibility | Cornea Max. score:4 |
Iris Max. score:2 |
Conjunctivae Max. score:3 |
Chemosis Max. score:4 |
| 24 h | 0/0/0.5 | 0/1/1 | 3/3/3 | 4/4/4 |
| 48 h | 0/0/0.5 | 0.5/0/0 | 3/2/3 | 4/4/4 |
| 72 h | 0/0/0 | 0/0/0 | 3/2/2 | 4/4/4 |
| Average 24 h, 48 h, 72 h | 0.11 | 0.28 | 2.66 | 4 |
| Reversibility within 22 days*) | c. | c. | c. | c. |
*) Reversibility: c.= completely reversible; n.c.= not completely reversible; n.= not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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