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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:
Jan/Feb 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Basic Violet 16

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK ltd. bzw. Intertauna UK ltd./Hack.a.Church
- Age at study initiation: Adult rabbits
- Weight at study initiation: Rabbit No.: G89 (3.1 kg); Rabbit No.: F93 (3.1 kg) and Rabbit No.: F94 (2.9 kg)
- Housing: Animals were individually housed
- Diet (ad libitum): sniff K4 standard diet
- Water (ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-65
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: January/February 1986

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 µL test substance
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: hypoallergen plaster (Beiersdorf No 2342); elastic adhesive bandage (Fixomull-Stretch Klebevlies, Beiersdorf No 2019)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48, 72 hours; 7 days

SCORING SYSTEM: Draize
- Method of calculation: mean of 24, 48, 72 hour values

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No adverse effects were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not induce any skin reaction and is therefore considered as not skin irritating.
Executive summary:

In a 4 h Acute Dermal Irritation/Corrosion, tree adult rabbits (HC:NZW) were exposed to 500 mL Basic Violet 16 Acetate under semi occlusive conditions.

Under the test conditions, the substance did not induce any skin reaction and is therefore considered as not skin irritating.