Synthetic resin, a reaction product of 4,4'-bis(N-maleimido)diphenylmethane with 3-aminobenzoic acid hydrazide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1989-10-27 to 1989-12-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

February, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

March, 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(methylenedi-p-phenylene)bismaleimide

EC Number:

237-163-4

EC Name:

1,1'-(methylenedi-p-phenylene)bismaleimide

Cas Number:

13676-54-5

Molecular formula:

C21H14N2O4

IUPAC Name:

1,1'-[methylenedi(4,1-phenylene)]di(1H-pyrrole-2,5-dione)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.4 - 2.5 kg, female 2.6 kg
- Fasting period before study: overnight
- Housing: female individually, males 2 animals/cage; stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen)
- Diet: ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: 4 days under test conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

The test article was applied moistened with bi-distilled water

Controls:

not required

Amount / concentration applied:

0.5 g/animal. The test article was applied moistened with bi-distilled water.

Duration of treatment / exposure:

4 hours

Observation period:

72 h with the reading points: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). On test day 1, 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze.
- Type of wrap if used: Covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 h

SCORING SYSTEM: Draize scoring system
- Method of calculation: according to EEC Council Directive 83/467/EEC, July 1983, Brussels, Belgium

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test item showed a primary irritation score of 0.00, when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident an the skin.

Other effects:

Coloration: In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Clinical symptoms / Mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy: No necropsy was performed. All animals were killed and discarded.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment, The test substance was found to cause a primary irritation score of 0.00, when applied to intact rabbit skin. There was no sign of irritation, thus, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to skin irritation.