Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1990-03-19 to 1990-03-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study performed similar to OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
This study was conducted in accordance with the Good Laboratory Practice regulations as described by the FDA (21 CFR Part 58) and (40 CFR Parts 160 and 792).

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylpentan-2-one oxime
EC Number:
203-298-2
EC Name:
4-methylpentan-2-one oxime
Cas Number:
105-44-2
Molecular formula:
C6H13NO
IUPAC Name:
4-methylpentan-2-one oxime
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 37905-27-4
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (65-85 °F)
- Stability under test conditions: Assumed stable for length of testing program

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable, 0.1 ml or 0.01 ml of neat test article

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 4 male and 5 female New Zealand White rabbits; Sterling Rabbitry, Wellsville, Utah
- Age at study initiation: Young adults
- Weight at study initiation: 2.0 to 3.5 kg at initiation/ either sex.
- Housing: individually housed in stainless steel, wire mesh bottom cages.
- Diet (e.g. ad libitum): Fresh Certified Agway Rabbit Feed was provided -ad libitum.
- Water (e.g. ad libitum): Fresh potable water - ad libitum.
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 61-70°C
- Humidity (%): 40-60 %
- Air changes (per hr): not less than10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreaded and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Group I and II: 0.1 mL (right eye only); Group III: 0.01 mL (right eye only)
Duration of treatment / exposure:
single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals per group; 3 groups
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, for Group II rabbits only: the eyes were rinsed with room temperature tap water for appriximately one minute, using a volume (200 - 300 mL) and velocity of flow which could not cause injury.
- Time after start of exposure: approximately 20 seconds following administration of test article.

OBSERVATION TIME POINTS
- Body weights: within 48 hours of receipt and prior to dosing
- Ocular reaction (response of the cornea, iris and conjunctivae): at prescreen (approximately 1-2 hours prior to dosing), 1, 24, 48, 72 hours and on Days 4 and 7 after test substance application.

SCORING SYSTEM:
The ocular reaction was assessed according to the Draize Standard Eye Irritation Grading Scale.

TOOL USED TO ASSESS SCORE:
Eye examinations were made with biomicroscopic slit lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Group I
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
Group I
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
Group I
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Remarks:
Group I
Basis:
other: animal #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Group I
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Group I/redness
Basis:
other: animal #1 and #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Group I/redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Group I/discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Group I/discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Group I/discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Remarks:
Group I
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Remarks:
Group I
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Remarks:
Group I
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
At prescreen, all animals were found to be free of ocular lesions.
The untreated control eyes, of all animals, were free of ocular irritation throughout the study period.

Group I
Grade 1 corneal opacity in 2/3 test eyes, grade 1 iritis in 1/3 test eyes and signs of conjunctival irritation (grade 3 redness in 3/3 test eyes, grade 4 chemosis in 3/3 test eyes and grade 3 discharge in 3/3 test eyes) were observed at the 1 hour scoring interval. The corneal and iridial effects resolved by the day 4 scoring interval and the conjunctival irritation cleared by the day 7 scoring intervals.

Group II
Grade 1 corneal opacity in 2/3 test eyes and signs of conjunctival irritation (grade 3 redness in 3/3 test eyes, grades 2-4 chemosis in 3/3 test eyes and grade 3 discharge in 3/3 test eyes) were observed at the 1 hour scoring interval. The corneal effects resolved by the 72 hour scoring interval and the conjunctival irritation cleared by the day 4 scoring interval. Grade 1 iritis was noted in 1/3 test eyes at the 24 hour scoring interval and persisted until the day 4 scoring interval.

Group III
Grade 1 corneal opacity in 3/3 test eyes and conjunctival irritation (grade 3 redness in 3/3 test eyes, grades 2-3 chemosis in 3/3 test eyes and grade 3 discharge in 3/3 test eyes were observed at the 1 hour scoring interval. Both the corneal effects and the conjunctival irritation resolved by days 7 scoring interval.
Grade 1 iritis was noted in 3/3 test eye-s at the 24 hour scoring interval and persisted in 1/3 test eyes until the day 4 scoring interval.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based upon the classification scale of the study protocol, MIBKO (199-89B) (administered neat at a volume of 0.1 ml) is classified as a Moderate Irritant under both rinsed and unrinsed conditions. The test item is also classified as a Moderate Irritant when administered neat at a lower volume of 0.01 ml.
Based on the criteria of the CLP regulation (EC) 1272/2008, the test item should be classified for eye irritation category 2..