Registration Dossier
Registration Dossier
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EC number: 204-709-8 | CAS number: 124-68-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Draize technique (Draize, J.H., Woodard, G. & Calvery, H.O. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. and Exp. Therapeutics. 82, 377–390.)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-amino-2-methylpropanol
- EC Number:
- 204-709-8
- EC Name:
- 2-amino-2-methylpropanol
- Cas Number:
- 124-68-5
- Molecular formula:
- C4H11NO
- IUPAC Name:
- 2-amino-2-methylpropan-1-ol
- Details on test material:
- AMP regular was tested. No details on purity
AMP-regular typically contains approx 98% AMP
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Duration of treatment / exposure:
- Different animals were instilled the test material in the eye in three successive studies:
- without rinsing
- with 30-second rinsing with distilled water 30 seconds after application
- with 30-second rinsing with distilled water 15 seconds after application
No further methods information was given. - Observation period (in vivo):
- scoring of results took place at 24 and 48 hours after exposure only. This was sufficient given the irreversible nature of the lesions.
- Number of animals or in vitro replicates:
- 6 animals in each study
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 45 seconds
- Score:
- 69.3
- Reversibility:
- not specified
- Remarks on result:
- other: group with 15-second exposure and 30-second rinsing
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 seconds
- Score:
- 89.3
- Reversibility:
- not specified
- Remarks on result:
- other: group with 30-second exposure and 30-second rinsing
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks:
- "vision destroyed" in all 6 animals
- Remarks on result:
- probability of severe irritation
- Remarks:
- unrinsed group
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks:
- "vision destroyed" in all 6 animals
- Remarks on result:
- probability of severe irritation
- Remarks:
- unrinsed group
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Unrinsed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision in all animals.
Rinsing of eyes after 15 or 30 seconds decreased mean score to 69.3/100 or 89.3/110, respectively. - Other effects:
- No further details
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material is considered to be a severe eye irritant, and there is little beneficial effect even when eyes are almost immediately flushed with water.
- Executive summary:
In studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits. In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not rinsed. AMP caused severe damage to the eyes and flushing almost immediately with water appeared to have little beneficial effect.
The damage caused by AMP appears likely to be due to the high pH/pKa value: pKa of 9.81 at 20°C.
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