Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication but only limited data is given. (Grading of effects of chemical is given, however detailed eye injury symptoms are not given.)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969

Materials and methods

Principles of method if other than guideline:
Method: according to Smyth, Carpenter, Weil, Pozzani and Striegel: Range-Finding Toxicity Data: List VI, Amer. Ind. Hyg. Assoc. J. 23: 95 (1962) and Carpenter and Smyth: Chemical Burns of the Rabbit Cornea, Am. J. Ophthal., 29: 1363 (1946) for details see any other information on materials and methods
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Aminopropoxy-2-ethoxy ethanol

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
other: test substance usually is used undiluted, if dilution is necessary, preferred solvent is propylene glycol, followed by water and in some cases deodorized kerosene ("Deobase")
Controls:
other: untreated eye serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): starting amount is 0.005 mL of undiluted chemical, volumes applied are scaled up until grading is possible, or substance is diluted if lowest volume of undiluted substance is categorized Grade 10
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
not given
Number of animals or in vitro replicates:
usually 5
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Carpenter and Smyth: Chemical Burns of the Rabbit Cornea, Am. J. Ophthal., 29: 1363 (1946) - see table1
individual scores are added together and then divided by the number of eyes to obtain the score of the injury and determine grade of injury (table2)

TOOL USED TO ASSESS SCORE: fluorescein staining

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal #1 - #5
Time point:
other: 24 hours
Score:
7
Max. score:
10
Reversibility:
not specified
Irritant / corrosive response data:
test substance is graded 7, meaning that an excess of a 15 % solution already gives injuries to the eye of up to 5.0 points (table1), including cornea opacity, iritis and necrosis
Other effects:
not given

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information