Registration Dossier
Registration Dossier
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EC number: 416-900-5 | CAS number: 79723-02-7 TMAP
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles. No information on test substance purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on purity
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on purity
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetramethylammonium hydrogen phthalate
- EC Number:
- 416-900-5
- EC Name:
- Tetramethylammonium hydrogen phthalate
- Cas Number:
- 79723-02-7
- Molecular formula:
- C12H17NO4
- IUPAC Name:
- tetramethylazanium 2-carboxybenzoate
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): TMAP
- Storage condition of test material: room temperature over silica gel
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately 12 to 16 weeks old
- Weight at study initiation: 2.22 - 2.54 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum (RABMA Rabbit diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 56-67
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 August 1993 To: 25 August 1993
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible within 14 days.
- Other effects:
- Other ocular effecs noted were a dulling of the normal lustre of the corneal surface (2 animals, 1 hour after treatment), sloughing of the cornea (in one eye at the 24 hour observation) and petechial haemorrhage of the conjunctival or nictitating membranes (in one eye at the 24, 48 and 72 hour observations).
Applicant's summary and conclusion
- Interpretation of results:
- other: cat. 2
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on an eye irritation test with TMAP according to OECD/EC guidelines and GLP principles, the test substance is found to be irritating to the eyes (classified cat 2).
- Executive summary:
An eye irritation test with TMAP was performed according to OECD/ EC guidelines and GLP principles. The mean corneal opacity score at 24, 48 and 72 hours of three rabbits was found to be 1, 1 and 0. The mean iris score was <1 for all animals, mean conjunctival score was 2 for one rabbit and <2 for the other two. Mean chemosis score were <2 for all three rabbits. Other ocular effecs noted were a dulling of the normal lustre of the corneal surface (2 animals, 1 hour after treatment), sloughing of the cornea (in one eye at the 24 hour observation) and petechial haemorrhage of the conjunctival or nictitating membranes (in one eye at the 24, 48 and 72 hour observations). All effects were reversible within 14 days.
Since the corneal opacity was ≥ 1 in 2 of the three tested animals (mean 24, 48 and 72 hours), TMAP is regarded as irritant to the eye (classified cat 2).
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