Benzyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-04-16 to 1984-05-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24th April 2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Journal Officiel de la Republique Francaise 21 April 1971 and 5 June 1973

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl methacrylate

EC Number:

219-674-4

EC Name:

Benzyl methacrylate

Cas Number:

2495-37-6

Molecular formula:

C11H12O2

IUPAC Name:

benzyl methacrylate

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Methacrylate de Benzyle (MABz)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.27 – 2.86 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): standard laboratory rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 4.5°C
- Humidity (%): 50-60%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contralateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

eyes were not rinsed after application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 (sex not given)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize, similar to OECD guideline 405 (adopted 24th April 2002)

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal: #2, #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.667

Max. score:

3

Reversibility:

fully reversible within: 3 d

Results 5

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal: #3, #5

Time point:

24/48/72 h

Score:

0.333

Max. score:

3

Reversibility:

fully reversible within: 2 d

Results 6

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal: #2, #3, #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal: #1, #5

Time point:

24/48/72 h

Score:

0.333

Max. score:

4

Reversibility:

fully reversible within: 2 d

Other effects:

small amount of conjunctival discharge was observed in one animal (#5) after 24 h, but not thereafter

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

BNMA is not irritating to the rabbit eye.

Executive summary:

In a primary eye irritation study similar to OECD guideline 405 (adopted 24th April 2002), 0.1 mL of BNMA (purity: 99 - 99.4%, according to supplier) was instilled into the conjunctival sac of 6 young adult New Zealand White rabbits (sex not given) without washing. Animals then were observed for 7 days.  Irritation was scored by the method of Draize.

 

No effects were observed in cornea and iris. Only minimal (grade 1) chemosis and redness were observed in 2 and 3 animals, respectively. All effects were reversible within 72 h.

 

In this study, BNMA is not irritant to the rabbit eye.

GHS criteria not met.

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