Tetramethylene dimethacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Study performed before implementation of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of chemicals in foods, druge and cosmetics, by the Staft of the Division of Pharmacology, US FDA, Bewertung von Augen-Läsionen nach Draize (1959)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: US FHSA Federal regulation: 16 CFR 1500.42

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

study performed before implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Tetramethylene dimethacrylate

EC Number:

218-218-1

EC Name:

Tetramethylene dimethacrylate

Cas Number:

2082-81-7

Molecular formula:

C12H18O4

IUPAC Name:

butane-1,4-diyl bis(2-methylacrylate)

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 1,4-Butandioldimethacrylat

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individually caged
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 50 – 60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

eys were not rinsed after application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed for substance removal after treatment

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

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

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

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

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

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

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

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

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Transient conjunctival irritating effects were seen 1, 2 and 8 hours after application in all 6 animals (conjunctival redness grade 2 after 1 hour, grade 1 or 0 after 2 and 8 hours, slight chemosis grade 1 and discharge grade 2). All effects were completely reversible at the 24 h scoring. From 24 h onward all scores were zero.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this primary eye irritation study 1,4-BDDMA is not an eye irritant.

Executive summary:

In a primary eye irritation study similar to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405),

0.1 mL of 1,4-BDDMA was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

Transient conjunctival irritating effects were seen 1, 2 and 8 hours after application. All effects were completely reversible at the 24 h scoring. From 24 h onward all scores were zero.

In this study, 1,4-BDDMA is not an eye irritant.

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