Registration Dossier
Registration Dossier
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EC number: 279-116-0 | CAS number: 79234-33-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from NTRL reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Initial Submission: Acute Toxicity of 4-methoxybenzenemethanamine with Cover Letter dated 082692
- Author:
- NTRL report
- Year:
- 1 992
- Bibliographic source:
- OTS0546455, NTRL report, 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the ocular irritation potential of 4-Methoxybenzylamine in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-anisylamine
- EC Number:
- 219-247-2
- EC Name:
- p-anisylamine
- Cas Number:
- 2393-23-9
- Molecular formula:
- C8H11NO
- IUPAC Name:
- p-Anisylamine
- Test material form:
- liquid
- Details on test material:
- - Name of test material: 4-Methoxybenzylamine
- IUPAC name: p-anisylamine
- Molecular formula: C8H11NO
- Molecular weight: 137.181 g/mole
- Smiles :O(c1ccc(cc1)CN)C
- Inchl: 1S/C8H11NO/c1-10-8-4-2-7(6-9)3-5-8/h2-5H,6,9H2,1H3
- Substance type: Organic
- Physical state: Liquid (Colorless to pale yellow)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 4-Methoxybenzylamine
- IUPAC name: p-anisylamine
- Molecular formula: C8H11NO
- Molecular weight: 137.181 g/mole
- Smiles :O(c1ccc(cc1)CN)C
- Inchl: 1S/C8H11NO/c1-10-8-4-2-7(6-9)3-5-8/h2-5H,6,9H2,1H3
- Substance type: Organic
- Physical state: Liquid (Colorless to pale yellow)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 14 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 animals eyes were washed with distilled water and for 3 animals eyes were not washed out
- Time after start of exposure: no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- It caused strong edema, erythema, necrosis of the adnexal structures, corneal opacity, and discharge within one hour in both washed and unwashed eyes. The irides could not be evaluated due to the presence of extensive corneal opacity. The animals were euthanatized for humane reasons at the one-hour observation point.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- 4-Methoxybenzylamine caused strong edema, erythema, necrosis of the adnexal structures, corneal opacity, and discharge within one hour in both washed and unwashed eyes. The irises could not be evaluated due to the presence of extensive corneal opacity. The animals were euthanatized for humane reasons at the one-hour observation point.
Since the animals were killed before the end of observation period due to severity of the effects, 4-Methoxybenzylamine can be considered to be corrosive to rabbit eyes. - Executive summary:
The ocular irritation potential of 4-Methoxybenzylamine was assessed in rabbits. 0.1 ml of undiluted test chemical was instilled in to the eyes of 6 New Zealand White rabbits. 3 animals eyes were washed with distilled water and for 3 animals eyes were not washed out(duration not specified). The rabbits were observed for signs of irritation till 14 days.
4-Methoxybenzylamine caused strong edema, erythema, necrosis of the adnexal structures, corneal opacity, and discharge within one hour in both washed and unwashed eyes. The irises could not be evaluated due to the presence of extensive corneal opacity. The animals were euthanatized for humane reasons at the one-hour observation point.
Since the animals were killed before the end of observation period due to severity of the effects, 4-Methoxybenzylamine can be considered to be corrosive to rabbit eyes.
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