Urea, reaction products with formaldehyde, glyoxal and methanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From 22 OCT 1985 to 26 OCT 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Urea, reaction products with formaldehyde, glyoxal and methanol

EC Number:

296-665-1

EC Name:

Urea, reaction products with formaldehyde, glyoxal and methanol

Cas Number:

92908-36-6

Molecular formula:

C2 H2 O2 .C H4 N2 O .C H4 O .C H2 O

IUPAC Name:

Urea, reaction products with formaldehyde, glyoxal and methanol

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre d'Elevage CEGAV, St. Mars d'Egrenne, France
- Weight at study initiation: 2.4 kg (median)
- Housing: single caged in fully conditioned rooms
- Diet: grains of Ref. 112C (U.A.R, Villemoisson sur Orge, France), ad libitum
- Water: flitered water (Millipore membrane 0.22 µm), ad libitum
- both, diet and water, were tested regularly on bacterial contamination
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h after the removal of the patch

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: ~ 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: wiping with sterile gauze patch
- Time after start of exposure: 4 h

SCORING SYSTEM: according to EU B.4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation at any time

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation at any time

Irritant / corrosive response data:

There was no erythema nor edema nor any other skin reaction visible at any time during the test.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the classification criteria of Regulation (EC) No. 1272/2008 the test material "ARKOFIX NFB conc" is no skin irritant under the conditions tested in this referable guideline study (EU method B.4). The test material contains relevant amounts of the submission substance. Therefore the test results are adequat to fulfil the endpoints requirements.

Executive summary:

Test material "ARKOFIX NFB conc" was subject to an acute dermal irritation /corrosion test in 6 male New Zealand rabbits according to EU method B.4. After the 4 h exposure to 0.5 mL of the undiluted test material under semi-occlusive conditions no skin effects were visible (erythema scores and edema scores: 0, in all animals at any time). Therefore the test item has not to be classified for skin irritation according to Regulation (EC) No. 1272/2008.