Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
Conducted study is in vivo and was conducted prior to the requirement for in vitro studies and before these asays were perfected for use
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study appears to have been conducted in accordance to a standard protocol (at the time) for assessing the eye irritation potential of compounds. Although there is limited information on the methods used the reporting is sufficient to come to a conclusion on the endpoint.

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

Reference
Name:
Unnamed
Type:
Constituent
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
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No details given

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
Animals were dosed with the test material, in one study the eyes were flushed 15-30 seconds after application, and in the other, they were not. No further methods information was given.
Observation period (in vivo):
scoring of results took place at 24 and 48 hours after exposure only. No further information on any subsequent observation period.
Number of animals or in vitro replicates:
6 animals in each study
Details on study design:
No additional Information

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
110
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: un flushed eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
69.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: eye flushed after 15 seconds
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
89.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: eye flushed after 30 seconds
Irritant / corrosive response data:
Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.
Other effects:
No details

Any other information on results incl. tables

Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated informationCriteria used for interpretation of results: EU
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 two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeard to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.