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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
Study period:
From 23 OCT 1984 to 27 OCT 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
o-anisidine
EC Number:
201-963-1
EC Name:
o-anisidine
Cas Number:
90-04-0
Molecular formula:
C7H9NO
IUPAC Name:
2-methoxyaniline
Details on test material:
- Name of test material (as cited in study report): Echtrot BB Base flüssig


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Weight at study initiation: 2.5 to 3.1 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/lippe, Germany), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x2.5 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: done with lukewarm tap water
- Time after start of exposure: 4 h


SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animal # 1 and 2 each
Time point:
other: mean of 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: initial, slight effect were fully reversible within 24 h
Irritant / corrosive response data:
30-60 minutes after end of exposure:
- All animals showed well defined erythema (score: 2) as well as very slight edema (score:1)

24 h reading:
- 2/3 animals still show well defined erythema (score:2), one animal shows only very slight erythema (score: 1)
- no more edema seen in any of the animals

48 h reading:
- all animals show very slight erythema (score: 1).

72 h reading:
-the erythema seen before vanished in all animals

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
Based on that findings the test substance is neither skin irritating nor skin corrosing. The test material contains relevant amounts of the submission substance. Therefore the test results are adequat to fulfil the endpoint requirements.
Executive summary:

Test material "Echtrot BB Base flüssig" was subject to an acute dermal irritation/corrosion test in 3 New Zealand White rabbits according to OECD TG 404. After the 4 h exposure to 0.5 ml of the undiluted test material under semi-occlusive conditions only minor effects were seen in all animals (erythema score: 0 -2; edema score: 0 -1). These effects were fully reversible until the 72 h reading. Based on that findings the test substance is neither skin irritating nor skin corrosing

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