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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
Study period:
02 August 1989 and 05 August 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
IUPAC Name:
Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
Test material form:
solid: particulate/powder
Details on test material:
- Description: Black powder
- Storage Conditions: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 11 to 13 weeks of age.
- Weight at study initiation: 2.6 to 3.0 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation: The rabbits selected for the study were all acclimated to the laboratory environment.
- Other: All animals were observed daily for signs of ill health or toxic signs.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19 °C.
- Humidity (%): 30-70 % relative humidity.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Approximately 24 h prior to application of the test material, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of test material.

VEHICLE
- The test material was administered as supplied by the Sponsor.
Duration of treatment / exposure:
4 hours
Observation period:
Examination of the treated skin was made on Day 1 (approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.
Number of animals:
Two females and one male.
Details on study design:
TEST SITE
- Area of exposure: An area of skin approximately 10 cm square.
- Type of wrap if used: A 0.5 g amount of test material was applied under a 2.5 cm square gauze pad moistened with 0.5 mL distilled water to one intact skin site. Each site was occluded with "Elastoplast" elastic adhesive dressing for the exposure period. The animals were not restrained during the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: The treatment site was washed using water to remove any residual test substance.
- Time after start of exposure: 4 hours.

OBSERVATION TIME POINTS
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.

SCORING SYSTEM:
- Method of calculation: Draize Irritation Score

Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
ERYTHEMA AND ESCHAR FORMATION:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 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 oedema (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
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None of the animals showed any response to treatment throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria.
Conclusions:
Under the conditions of the study, a single semi-occlusive application of test material to intact rabbit skin for four hours elicited no dermal irritation.
Executive summary:

The potential of the test material to cause eye irritation was determined in a GLP study which was conducted in accordance with the standardised guideline OECD 404.

The skin irritancy potential of the test material was investigated in New Zealand white rabbits. Approximately 24 hours prior to application of the test material, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square. A 0.5 g amount of test material, was applied under a 2.5 cm square gauze pad moistened with 0.5 mL distilled water to one intact skin site on each animal. Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period. The animals were not restrained during the exposure period and were returned to their cages. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test material. Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.

Under the conditions of the study, a single semi-occlusive application of test material to intact rabbit skin for four hours elicited no dermal irritation.