Reaction products of Glycerin formal and 2-Propenoic acid, 2-methyl-, methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure according to national (US) standard. Pre-GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

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:

Tetrahydrofurfuryl methacrylate

EC Number:

219-529-5

EC Name:

Tetrahydrofurfuryl methacrylate

Cas Number:

2455-24-5

Molecular formula:

C9H14O3

IUPAC Name:

tetrahydrofuran-2-ylmethyl methacrylate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tetrahydrofurfurylmethacrylat

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

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 control sites on the same animals

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

Remarks:

intact skin

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: timepoint

Remarks:

no scoring at 48 h

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

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

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: timepoint

Remarks:

no scoring at 48 h

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks:

study termination at 72 h, thus, reversibility cannot be evaluated

Remarks on result:

other: timepoint

Remarks:

no scoring at 48 h,

Results 4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

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

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: timepoint

Remarks:

no scoring at 48 h

Irritant / corrosive response data:

1/6 animals showed very slight erythema (grade 1) after 24 h, which was fully reversible within 72 h. In 1/6 animals very slight erythema (grade 1) was observed after 24 and 72 h. 4/6 animals showed no skin reactions at all.

Abraded skin:
1/6 animals showed very slight erythema (grade 1) after 24 and 72 h.

The observation time did not extend beyond 72 hours, even though a slight skin response was still present at that time in one animal. Therefore, the full reversibility of the effects can not be proved. However skin effects showed clear tendency of reversibility. At study termination, reversibility was complete in 1/2 affected animals. Therefore, a full reversibility seems to be very likely if the observation period had been extended to the period stipulated in the international guidelines.

Other effects:

No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In this primary dermal irritation study in rabbit, THFMA 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 THFMA (according to sponsor's information: purity ca. 98%) 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.

Very slight dermal irritation response was observed in 1/6 animals on intact and abraded skin after 24 and 27 h and in 1/6 animals on intact skin after 24 h. All other animals showed no dermal irritation response.

The observation time did not extend beyond 72 hours, even though a slight skin response was still present at that time in one animal. Therefore, the full reversibility of the effects can not be proved. However skin effects showed clear tendency of reversibility. At study termination, reversibility was complete in 1/2 affected animals. Therefore, a full reversibility seems to be very likely if the observation period had been extended to the period stipulated in the international guidelines.

In this study, THFMA 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.

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