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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: well performed research study, conducted prior to GLP and OECD guideline implementation

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA; Federal Register, Vol. 38, No. 187, 1973
Deviations:
no
GLP compliance:
no
Remarks:
not available at that time

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2,5-dimethoxyphenyl)acetamide
EC Number:
222-423-1
EC Name:
N-(2,5-dimethoxyphenyl)acetamide
Cas Number:
3467-59-2
Molecular formula:
C10H13NO3
IUPAC Name:
N-(2,5-dimethoxyphenyl)acetamide
Details on test material:
- Name of test material (as cited in study report): Acetchinonbase

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 -2.0 kg
- Housing: singel cages
- Diet: Mischfutter ERKA 8300, ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of each animal served as control
Amount / concentration applied:
100 mg of the undiluted substance
Duration of treatment / exposure:
Duration of treatment: 24 hour,
after the 24 h examination eyes were rinsed with physiol. saline.
Observation period (in vivo):
Observation period: 14 days
Examinations: at 1, 7, 24, 48, 72 h, 7, 14 d post application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: physiolog. saline solution
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2, conjunctiva redness; 0 - 3; conjunctiva chemosis: 0 - 4

TOOL USED TO ASSESS SCORE: magnifying glass (binocular) / fluorescein after 24 hours/ UV-light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 10, 22, 23, 76, 77, 99 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: # 10, 22, 23, 76, 77, 99 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: # 99
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no signs of irritation (conjunctivae) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: # 10, 23 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: # 22, 76 each
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal: # 7
Time point:
other: mean of 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal: # 10, 22, 23, 77, 99 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial signs of slight irritation were fully reversible within 7h
Irritation parameter:
chemosis score
Basis:
animal: # 76
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on results of this study Acetchinonbase is not considered to cause a relevant irritation of the eye.
Executive summary:

Acetchinonbase was tested for eye irritating properties according to FDA; Federal Register, Vol. 38, No. 187, 1973. Following this protocol 100 mg of the test substance were placed into the conjunctival sac of one eye from each of 6 Himalayan rabbits. The untreated eye of each rabbit served as control. 24 h post application the remaining substance was rinsed with physiol. saline. The animals were periodically examined for signs of eye irritation. Mean scores (mean of 24, 48, and 72 h) were calculated for cornea, iris, conjunctivae redness and chemosis for each rabbit.

All mean scores calculated were below threshold values and indicate, that the substance is not irritating to eyes. Effects observed were only of minor extent and were fully reversible within 7 days.