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EC number: 201-853-3 | CAS number: 88-72-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- secondary source
- Title:
- European Union Risk Assessment Report - 2-Nitrotoluene
- Author:
- European Commission - European Chemicals Bureau
- Year:
- 2 008
- Bibliographic source:
- Office for Official Publications of the European Communities
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no GLP conform. No analytical purity reported
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register, Vol 38, No. 187, 1973
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
Test material
- Reference substance name:
- 2-nitrotoluene
- EC Number:
- 201-853-3
- EC Name:
- 2-nitrotoluene
- Cas Number:
- 88-72-2
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- 1-methyl-2-nitrobenzene
- Details on test material:
- Name of test material (as cited in study report): o-nitrotoluene
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Himalayan (SPF-Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: the animals were housed individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Amount applied
TEST MATERIAL
- Amount(s) applied: 0.1 ml instilled in to the conjunctival sac of the eye
- Concentration: undiluted test substance
REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time schedule for washing: Eyes were washed with physiological saline solution after the 24h reading
SCORING SYSTEM
- according Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp or magnifying glass and fluorescein (1:10,000)
-Time schedule for scoring: 1, 7, 24, 48, 72h after application - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- until 72 hours
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- The results were the following:
- Cornea Opacity: 0/6 animals throughout observation period
- Redness: slight erythema (after 24h), initially seen in 6 and 5 animals (after 1 and 7h, respectively). Erythema was totally reversed in all but 1 animal whose eye still manifested slight erythema. No erythema in any animal at 48 and 72h post instillation of the eye.
- Iris: 0/6 animals throughout observation period
- Swelling: 1/6 after 7h. Reversible after 24 h. No swelling observed
Any other information on results incl. tables
| Animal | Cornea Opacity | Iris | Conjunctiva Redness | Swelling |
Readings | |||||
24h | 26 | 0 | 0 | 0 | 0 |
27 | 0 | 0 | 0 | 0 | |
28 | 0 | 0 | 0 | 0 | |
29 | 0 | 0 | 1 | 0 | |
30 | 0 | 0 | 0 | 0 | |
31 | 0 | 0 | 0 | 0 | |
48h | 26 | 0 | 0 | 0 | 0 |
27 | 0 | 0 | 0 | 0 | |
28 | 0 | 0 | 0 | 0 | |
29 | 0 | 0 | 0 | 0 | |
30 | 0 | 0 | 0 | 0 | |
31 | 0 | 0 | 0 | 0 | |
72d | 26 | 0 | 0 | 0 | 0 |
27 | 0 | 0 | 0 | 0 | |
28 | 0 | 0 | 0 | 0 | |
29 | 0 | 0 | 0 | 0 | |
30 | 0 | 0 | 0 | 0 | |
31 | 0 | 0 | 0 | 0 | |
Mean (24h-72h) | 26 | 0.0 | 0.0 | 0.0 | 0.0 |
27 | 0.0 | 0.0 | 0.0 | 0.0 | |
28 | 0.0 | 0.0 | 0.0 | 0.0 | |
29 | 0.0 | 0.0 | 0.3 | 0.0 | |
30 | 0.0 | 0.0 | 0.0 | 0.0 | |
31 | 0.0 | 0.0 | 0.0 | 0.0 | |
Mean (24h-72h) | allanimals | 0.0 | 0.0 | 0.1 | 0.0 |
Applicant's summary and conclusion
- Executive summary:
Hollander and Weigand (1975):
The skin irritation of 2-nitrotoluene has been investigated in a study similar to OECD guideline 405 with deviations (no details on substance purity, prior to GLP).
The test substance (purity not given) was applied undiluted (0.1 ml/rabbit) in the conjunctival sac of 6 rabbits. The exposure lasted 24 h exposure, and observations were conducted at 1, 7, 24, 48 and 72 h. The irritation evaluation was made by means the Draize score method.
The results were the following:
- Cornea score: 0
- Conjunctiva score: 0.1 (fully reversible)
- Iris score: 0
- Chemosis score: 0
In accordance with the criteria laid down by the EU and GHS for the evaluation of eye irritation, 2 -nitrotoluene does not need to be classified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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