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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics, by the Staff of the Division of Pharmacology, US FDA, skin toxicity according to Draize (1959)
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
1-methyltrimethylene dimethacrylate
EC Number:
214-711-0
EC Name:
1-methyltrimethylene dimethacrylate
Cas Number:
1189-08-8
Molecular formula:
C12H18O4
IUPAC Name:
butane-1,3-diyl bis(2-methylacrylate)
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 1,3-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 (adult)
- Weight at study initiation: mean 2.5 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 (%): 50 to 60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #3, #4, #5, #6
Time point:
other: mean 24, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal: #2, #3, #4, #5, #6
Time point:
other: mean 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, no scoring at 48 h
Irritant / corrosive response data:
Intact skin:
5/6 animals showed a very slight erythema (barely perceptible, score 1) at the 24-hour scoring, which was fully reversible at the 72-hour scoring.
1/6 animals showed a very slight edema (barely perceptible, score 1) at the 24-hour scoring, which was fully reversible at the 72-hour scoring.

Abraded skin:
5/6 animals showed a very slight erythema (barely perceptible, score 1) at the 24-hour scoring, which was fully reversible at the 72-hour scoring.
All animals were free of edema at all scorings.
Other effects:
No other effects were reported.

Any other information on results incl. tables

- Only the scoring for intact skin was considered.

rabbit number

reaction

24 h

72 h

intact

abraded

intact

abraded

1

erythema

1

1

0

0

edema

1

0

0

0

2

erythema

0

0

0

0

edema

0

0

0

0

3

erythema

1

1

0

0

edema

0

0

0

0

4

erythema

1

1

0

0

edema

0

0

0

0

5

erythema

1

1

0

0

edema

0

0

0

0

6

erythema

1

1

0

0

edema

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study 1,3-BDDMA is not irritant to rabbit skin (no need to be classified according to regulation (EC) 1272/2008 or UN-GHS).

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 1,3 -BDDMA (according to supplier's information: purity ca. 90%) 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.

 

24 h after application of the test item in 5/6 animals a very slight erythema (grade 1) was present at treated intact and abraded skin sites. 1/6 treated intact skin sites a very slight edema (grade 1) was present. All effects were reversible within 72 h.

In this study, 1,3 -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 only very slight irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also not show a more than very slight irritating activity 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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