reaction product of diphenylmethanediisocyanate, toluenediisocyanate ( reaction mass of isomers: 65 % 2,4- and 35 % 2,6-diisocyanate), octylamine, oleylamine and 4-ethoxyaniline (molar ratio 3.88:1:6.38:0.47:2.91)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-16 until 1999-02-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 July 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

EPA 712-C-96-196, June 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-970-4

EC Name:

-

Cas Number:

1266545-66-7

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene

Details on test material:

NA

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg, Germany
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free-TPF
- Water: tap water
- Acclimatisation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: artificial light, lighting regime 12 : 12 hours, light 6.30 -18.30

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

other: CMC (drop down)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Single dose of 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (14 days observation period was not required as no indications which had to be examined for reversibility were observed).

Number of animals:

3 female animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on one side of the dorsal area
- Type of wrap if used: the test item was applied to the patch first (gauze patch), and then applied to the skin. The patch was fixed with a semi-occlusive dressing with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: as indicated in the OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

mean score animal 1, 2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

mean score animal 1, 2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period.

Other effects:

No other effects

Any other information on results incl. tables

There were no significant body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Under the conditions of this study, the test substance was considered to have no skin irritation/corrosive effects.

Executive summary:

The test substance was tested for its skin irritation/ corrosion properties in a study performed according to EU Method B.4, OECD Guideline 404 and EPA OPPTS 870.2500. The test substance was applied to one site of the clipped back of 3 rabbits at a dose of 0.5 g per application site while the untreated side served as control. The application site was covered with a semi-occlusive bandage for a 4 hour - contact/ exposure time. Observations were recorded and compared to the control sites, 1, 24, 48 and 72 hours after removal of the patch. The test item showed no irritant/ corrosive effects on the intact skin within 72 hours after removal of the test item. No other clinical signs of toxicity were observed. Under the conditions of the study, the test substance was considered to have no irritation/corrosive properties.