Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental work performed during April and May 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was performed according to OECD Test Guideline 404 Acute Dermal Irritation/Corrosion and in compliance with Good Laboratory Practice standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P5183
- Physical state: Brown viscous fluid
- Composition of test material, percentage of components:
76.4% 3,5-diethyl-2,4-diaminotoluol
21.0% 3,5-diethyl-2,6-diaminotoluol
- Analytical purity: 97.4%
- Impurities (identity and concentrations):
0.6% ?-ethyl-2,?-diaminotoluol
0.8% ?-ethyl-2,?-diaminotoluol
traces 2,6-diethylaniline
0.2% forward unknown
0.9% trailing unknown
0.165 wt% tar
0.009% water content
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldborough, Hull, HU11, 4QE
- Weight at study initiation: 2.98 to 3.46 kg
- Housing: individually, grid floor cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 3 days


ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 20°C
- Humidity: 47 to 65%
- Photoperiod (hrs dark / hrs light): 10 hrs dark/ 14 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated areas of skin served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: test material applied to an area of skin approximately 6 cm^2, volume not stated
- Concentration (if solution): undiluted
Duration of treatment / exposure:
The test material was administered once only for a contact period of 4 hours.
Observation period:
One hour after removal of the wrappings, the skin reactions were scored. The evaluation was repeated 24, 48 and 72 hours after removal of the patches.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: The test material was removed by skin wipe with a disposable paper towel moistened with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM*
Erythema and eschar formation
0 = no erythema
1 = very slight erythema (barely perceptible)
2 = well-defined erythema
3 = moderate to severe erythema
4 = severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation
0 = no oedema
1 = very slight oedema (barely perceptible)
2 = slight oedema (edges of area well-defined by definite raising)
3 = moderate oedema (raised approximately 1 mm)
4 = severe oedema (raised more than 1 mm and extending beyond the area of exposure)

All other reactions were recorded.

* Draize, J.H. (1959) Association of the Food and Drug Officials in the U.S., Austin, Texas, "The appraisal of the safety of chemicals in foods, drugs and cosmetics".

EVALUATION OF DATA
The sum of the 24 and 72 hour values for erythema and oedema (12 scores) was divided by 6 to give the primary irritation index of the test material. The test material was classified according to the following scheme:

Primary irritation index / Classification of irritancy
0 / non-irritant
>0 - 2 / slight
>2 - 5 / moderate
>5 / severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 0
Irritant / corrosive response data:
No positive observations of erythema or oedema were noted in any animal during the 72 hour observation period.

Applicant's summary and conclusion

Conclusions:
The test material was not irritating to rabbit skin and was not corrosive.