Registration Dossier
Registration Dossier
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EC number: 252-360-5 | CAS number: 35092-89-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl hydrogen 2-nitroterephthalate
- EC Number:
- 252-360-5
- EC Name:
- Methyl hydrogen 2-nitroterephthalate
- Cas Number:
- 35092-89-8
- Molecular formula:
- C9H7NO6
- IUPAC Name:
- 4-(methoxycarbonyl)-3-nitrobenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): Nitro-MMT
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach; Chbb: NZW (SPF)
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.9 - 3.9 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet: Altromin 2123 maintenance diet-rabbits, ad libitum. Hay, approx. 15 g / day
- Water: from automatic water dispensor, ad libitum)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Lighting time: 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye of the animal served as control
- Amount / concentration applied:
- 100 mg into the conjunctival sac of the left eye
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (with isotonic saline): 24 hours after application and at all other examination times
SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conj. redness: 0 - 3; conj. chemosis: 0 - 4
TOOL USED TO ASSESS SCORE: UV light after instillation of one drop of 0.01 % fluorescein-sodium solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 163, 178 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 177
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: # 163
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: # 177, 178 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 163
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 177
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 178
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 163
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 177
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 178
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- From one hour up to 72 hours p.a. the conjunctivae of the animals showed definitely injected blood vessels up to diffuse beefy red colours as well as slight up to obvious swellings with about half dosed lids. From one hour up to 24 hours p.a. the iris of one animal was red and up to 72 hours p.a. diffuse areas of opacity were noted at the cornea of the animals. Additional, hemorrhages were observed on the nictating membran of two animals. Furthermore a clear, colourless or white-yellow viscous discharge was noted. 7 days p.a. the irritations were reversible.
- Other effects:
- No other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Testing of Nitro-MMT for primary eye-irritation in the rabbit showed, that the substance is irritating to eyes.
- Executive summary:
Nitro-MMT was tested for eye irritation according to OECD 405. Following this guideline one eye of each of three New Zealand albino rabbits was treated with 100 mg of the test item. The exposure period was 24 hours.
From one hour up to 72 hours p.a. the conjunctivae of the animals showed definitely injected blood vessels up to diffuse beefy red colours as well as slight up to obvious swellings with about half closed lids. From one hour up to 24 hours p.a. the iris of one animal was red and up to 72 hours p.a. diffuse areas of opacity were noted at the cornea of the animals. Additional, hemorrhages were observed on the nictating membran of two animals. Furthermore a clear, colorless or white-yellow viscous discharge was noted. 7 days p.a. the irritaions were reversible.Based on these findings Nitro-MMT has to be regarded as irritating to eyes.
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