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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
28182-81-2
Cas Number:
28182-81-2
IUPAC Name:
28182-81-2
Constituent 2
Chemical structure
Reference substance name:
HDI oligomers, isocyanurate
EC Number:
931-274-8
Cas Number:
28182-81-2
Molecular formula:
(C8H12N2O2)n
IUPAC Name:
HDI oligomers, isocyanurate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Regal Group UK, Great Bookham, Surrey, UK.
- Age at study initiation: approx. 13 to 14 weeks
- Weight at study initiation: weight range of 3.0 - 3.4 kg
- Housing: individually in metal cages with perforated floors
- Diet and water: ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment. No information concerning period of time.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19
- Humidity (%): 30-70
- Air changes (per hr): approx. 19
- 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 skin areas of the test animal served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Examinations were terminated after 6 days, since all changes had completely subsided then.
Number of animals:
3 (two males, one female)
Details on study design:
TEST SITE: Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm. Approximately 0.5 mL of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours.

REMOVAL OF TEST SUBSTANCE: At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

SCORING SYSTEM:
Erythema and eschar formation: No erythema 0; very slight erythema (barely perceptible) 1; well-defined erythema 2; moderate to severe erythema 3; severe erythema (beef redness) to slight eschar formation (injuries in depth) preventing erythema reading 4.
Oedema formation: No oedema - 0; very slight oedema (barely perceptible) 1; slight oedema (edges of area well-defined by definite raising) 2; moderate oedema (raised approximately 1 millimetre) 3; severe erythema (raised more than 1 millimetre and extending beyond the area of exposure) 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: mean score: 0.66
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: mean score: 1.7
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema with or without very slight to slight oedema was seen in all animals. These reactions gradually ameliorated and had resolved in all instances by Day 5 or Day 6.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Executive summary:

An Acute Dermal Irritation/Corrosion test was conducted according to OECD TG 404. In this study very slight erythema with or without very slight to slight oedema was seen in all animals (Mean scores of time points 24, 48, and 72 h: 1 for erythema, 0.8 for oedema). These reactions gradually ameliorated and had resolved in all instances by Day 5 or Day 6. No signs of toxicity or ill health were observed.