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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Basic Brown 022
IUPAC Name:
Basic Brown 022

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: animals were housed in single cages.
- Diet: laboratory diet was provided ad libitum. The batch of the diet used for the study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: diluted in DMSO (50 %)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1.0 ml of the solution
Duration of treatment / exposure:
4 hour
Observation period:
72 hours
Number of animals:
Three rabbits
Details on study design:
TEST SITE
- Area of exposure: substance was introduce under a square patch of surgical gauze, measuring 6.5 cm^2.
- Type of wrap if used: animals were immobilized with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.

OBSERVATION TIME POINTS
30 minutes, 24, 48 and 72 hours.

SCORING SYSTEM:
The irritation was measured by patch test technique on the intact skin.
The resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The irritation score resulted to be 0.

Any other information on results incl. tables

Animal N. Reaction 30 min 24 hrs 48 hrs 72 hrs
Male 201 Erythema 0 0 0 0
Oedema 0 0 0 0
Male 202 Erythema 0 0 0 0
Oedema 0 0 0 0
Male 203 Erythema 0 0 0 0
Oedema 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Non irritating
Executive summary:

The skin irritation potential of the test item was tested using three rabbits (New Zealand white Rabbits). 1.0 ml of the solution (test item diluted in DMSO at 50 %) was placed into skin contact, under occlusive bandage, over a period of 4 hours. The skin reactions were inspected after 30 min., 24, 48 and 72 hours after exposure.

The irritation was measured by patch test technique on the intact skin and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

The irritation score resulted to be 0.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were in lower than 2.3 for both erythem and oedema in all the treated rabbits; no signs of irritation were recorded during the observation priod. Therefore, the substance does not meet the criteria to be classified as skin irritating, according to the CLP Regulation (EC 1272/2008).

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