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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08.04.1999-29.06.1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-butoxyethoxy)ethyl methacrylate
EC Number:
230-813-8
EC Name:
2-(2-butoxyethoxy)ethyl methacrylate
Cas Number:
7328-22-5
Molecular formula:
C12H22O4
IUPAC Name:
2-(2-butoxyethoxy)ethyl 2-methylprop-2-enoate
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals
Sex. species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study.
Breeder. Elevage Cunicole de Val de Sel1e, 80160 Prouzel, France.
Number of animals: 3
Identification: the animals were identified individually with a metal ear tag.
Weight: on the day of treatment, the animals had a mean body weight ± standard deviation of 2.7 ±0.2kg.
Acclimatization: at least 5 days before the beginning of the study.

Environmental conditions
The conditions in the animal room were set as follows:
· temperature: 18 ± 3°C
· relative humidity: 30 to 70%
. light/dark cycle: 12 hlI2 h
· ventilation: approximately 12 cycles/hour of filtered, non~recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
Each cage was equipped with a food container and a water bottle.

Food and water
During the study. the animals had free access to 112 C pelleted diet (UAR. 91360 Villemoissonsur-Orge, France).
Each batch of food was analysed by the supplier for composition and contaminant levels.
The diet formula is presented in appendix 2.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are perfonned regularly by external laboratories.
The results of these analyses are archived at err.
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
Eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance
Number of animals or in vitro replicates:
3
Details on study design:

The study design was established according to available infonnation on the test substance and according to the OECD (No. 405) and EC (92169/EEC. 8.5) guidelines.
As possible irritant effects were anticipated, the test substance was administered to a single animal (No. 768) in the first instance.
Since the test substance was not severely irritant on this first animal, it was then evaluated on two other animals (Nos. 769 and 770).

Administration of the test substance
A single dose of 0.1 mt of the undiluted test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test substance.

OCULAR EXAMINATIONS
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the
test substance.
Following the OEeD and EC guidelines:
• when there was no evidence of irritation after 72 hours, the study was ended.
• when there was persistent ocular irritation after 72 hours, the observation period was extended
to a maximum of 21 days (until day 22) in order to detennine the progress of the lesions and
their reversibility.
• when severe irritant effects were observed, the animals were killed on humane grounds.
Any change in the animals'behaviour was noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Classification of eye irritation studies according GHS-criteria

 

Substance:Butyldiglycol methacrylate             BDGMA                               CAS:7328-22-5

 

Internal No.:LITSU 12-0039

 

Date/Expert:12-11-02/Am

 

Animal No.

Corneal opacity/Hornhauttrübung[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

n.d.

n.d.

 

2

0

0

0

0

n.d.

n.d.

 

3

0

0

0

0

n.d.

n.d.

 

 

 

 

 

 

 

 

none

 

 

 

 

 

 

 

 

Animal No.

Iritis/Regenbogenhautentzündung[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

n.d.

n.d.

 

2

0

0

0

0

n.d.

n.d.

 

3

0

0

0

0

n.d.

n.d.

 

 

 

 

 

 

 

 

none

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Animal No.

Conjunctiva redness (erythem) /Bindehautrötung[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

1

0

0

0.33

n.d.

n.d.

 

2

1

1

0

0.66

n.d.

n.d.

 

3

1

0

0

0.33

n.d.

n.d.

 

 

 

 

 

 

 

 

none

 

 

 

 

 

 

 

 

Animal No.

Conjunctiva chemosis /Bindehautödem[Scores]

 

Mean Draize score in 2 of 3 animals

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

1

0

0

0.33

n.d.

n.d.

 

2

1

1

0

0.66

n.d.

n.d.

 

3

1

1

0

0.66

n.d.

n.d.

 

 

 

 

 

 

 

 

none

 

 

Classification:

Hazard Category

 

none

 


 

n.d. = no data

 

Classification Criteria for serious Eye Damage/Eye Irritation

 

Category 1

 

  • Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
  • Mean Draize score in 2 of 3 animals:

     corneal opacity≥ 3

     iritis ≥ 1,5

 

 

Category 2

 

  • Reversible adverse effects on cornea, iris, conjunctiva
  • Mean Draize score in 2 of 3 animals:

corneal opacity1

iritis1

redness2

chemosis2

 

 

Subcategory 2A

 

  • Reversible in 21 days

 

Subcategory 2B

 

  • Reversible in 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study acc. OECD 405 3 rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
The irritations were fully reversible within 72 hours.
Butyldiglycol is not classified acc. EU-GHS criteria.
Executive summary:

In an eye irritation study acc. OECD 405 3 rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. The irritations were fully reversible within 72 hours.

Butyldiglycol is not classified acc. EU-GHS criteria.

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