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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment with restrictions (solid substance tested undiluted without moistering, no individual irritation scores given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
Patch test according to the method described in § 1500.41 in the Federal Register 38, No. 187, 27 Sep 1973, page 27019 (Draize test).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Echtorange GR Base = 2-nitro-1-aminobenzol
- Analytical purity: 98.5-99.5% base

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: SPF-Albino-Himalayan rabbits, Hoe:HIMK (SPFWiga)
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: 1/cage
- Diet (ad libitum): Erka 8300 (Robert Koch oHG/Hamm, Germany)
- Water (ad libitum): tap water

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, abraded and non-abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: the test substance was applied to a gauze patch that was applied to the skin by means of adhesive tape, covered by PVC foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize scoring system (Federal Register§ 1500.41 in the Federal Register 38, No. 187, 27 Sep 1973, page 27019)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-48-72 hrs
Score:
0
Max. score:
8
Reversibility:
other: no skin irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU