Tetramethylene dimethacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

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:

1977

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, skin toxicity according to Draize (1959)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: US FHSA Federal regulation: 16 CFR 1500.41

Deviations:

no

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean 2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one site shaved/intact + one site shaved/abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites (one intact, one abraded) on each animal served as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): used as suppplied

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- The test material was applied to two clipped areas on each of six animals, one abraded and one left intact.
- Area of exposure: 2.5 x 2.5 cm
- Coverage ad wrap: Test sites were covered with medical strips which were fixed by leucoplast stripes. Whole animal trunk was wrapped in rubberized impervious cloth to minimize evaporation of the test substance. The animals were immobilized for the 24 hour exposure period.

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

SCORING SYSTEM: erythema/eschar and edema scoring similar to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

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

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact and abraded skin, no scoring at 48 h

Results 2

Irritation parameter:

edema score

Basis:

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

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact and abraded skin, no scoring at 48 h

Irritant / corrosive response data:

Intact skin:
All animals showed no reactions at all.

Abraded skin:
All animals showed no reactions at all.

Other effects:

No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this primary dermal irritation study in rabbit, 1,4-BDDMA is not a dermal irritant.

Executive summary:

In a primary dermal irritation study similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of 1,4 -BDDMA to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored similar to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404.

No dermal irritation response was observed, neither at the intact nor at the abraded application sites.

In this study, 1,4 -BDDMA is not a dermal irritant..

Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.