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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, guideline study; no data on test substance purity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
28182-81-2
Molecular formula:
Unspecified (UVCB substance)
Constituent 2
Reference substance name:
Hexamethylen diisocyanate, oligomerisation product (biuret type)
IUPAC Name:
Hexamethylen diisocyanate, oligomerisation product (biuret type)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Age at study initiation: adult animals
- Weight at study initiation: 3.02, 2.93 and 2.94 kg (3 males)
- Housing: single housing, cage made of stainless steel with wire mesh walk floors, (40 cm x 51 cm), no bedding in the cages
- Diet: Kliba Labordiaet 341, 4 mm, Klingentalmuehle AG, CH-Kaiseraugust, Switzerland (about 130 g/animal/day)
- Water: tap water, about 250 mL/animal/day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site of the same animal served as control
Amount / concentration applied:
approx. 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
8 days (as no skin reaction was observed at that time)
- Frequency of readings: about 1 h after removal of the patch; 24, 48, 72 h and 8 days after application
- Frequency of observation: twice each workday and once on saturday, sunday and public holidays
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: the test patch was secured with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Details on results

Readings

Animal No.

Erythema

Edema

1h

1

0

0

2

1

0

3

0

0

24 h

1

1

0

2

2

1

3

2

1

48 h

1

0

0

2

2

0

3

2

0

72 h

1

0

0

2

1

0

3

0

0

8 d

1

0

0

2

0

0

3

0

0

Mean

(24 – 72 h)

1

0.33

0.00

2

1.67

0.33

3

1.33

0.33

Mean

 

1.11

0.22

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information