PIGMENT RED 5021B

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-06-25 until 1991-06-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 404, adopted 1981), GLP compliance. In deviation from OECD guideline 404, adopted 2002, the test item was applied occlusively.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

Test guideline 2

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

Details on test material:

- Purity: > 90%
- Physical properties: solid, red
- Storage conditions: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7 950 Biberach/Riss
- Age at study initiation: 9-13 weeks old
- Weight at study initiation: 2570 to 2920 g
- Housing: the animals were housed individually in metal cages
- Diet: ad libitum standard rabbit pellet
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Controls:

other: A control gauze patch was applied to the contralateral flank of each animal

Amount / concentration applied:

0.5 g of test article

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 12- 16 cm² of the animal's flank
- Type of wrap if used: The patches (gauzes patches bearing the test item) were loosely covered with an aluminum foil (approx.
36 cm² ) and held in place for 4 hours by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated

SCORING SYSTEM:
According to the scoring system given in OECD guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1, 2, 3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1, 2, 3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

- One hour after patch removal, a slight edema reaction was observed in two animals. In all animals the evaluation of a possible erythema reaction was impeded because the application area was red-stained.
- No reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.

Any other information on results incl. tables

- No effect was observed on the animals bodyweight

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU