Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1975
Report date:
1975
Reference Type:
study report
Title:
Unnamed
Year:
1975
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

Constituent 1
Chemical structure
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

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.