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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
March 6th, 2000 - March 10th, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions. Lack of details on test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, lack of details on test substance.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: white pellets
- Analytical purity: not reported
- Lot/batch No.: 00010271
- Expiration date of the lot/batch: 10 years
- Storage condition of test material: amient temperature and out of light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Supplier (76410 Saint-Aubin-Les-Elbeuf, France).
- Age at study initiation: not reported
- Weight at study initiation: 1.8 kg and more
- Housing:individually in stainless steel cages on floor grid
- Diet (e.g. ad libitum): Ergilap Anco, COFNA, France.
- Water (e.g. ad libitum): tap water, periodically analyzed chemicophysically and bacteriologically
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: mineral oil
Controls:
other: vehicle alone on different site of the treated animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
The crunched test substance (fine powder) was applied soaked with mineral oil (Sigma batch 116 H 1202)
- Amount(s) applied (volume or weight with unit): 0.25 mL
Duration of treatment / exposure:
4 hours
Observation period:
Readings at 1, 24, 48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk
- % coverage: 2.5 cm x 2.5 cm gauze patch
- Type of wrap if used: Micropore tape of 5 cm x 5 cm, extensible bandage (type of varicose vein bandage) fixed with Micropore

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

SCORING SYSTEM:
Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals and 3 reading timepoints
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Other effects:
All animals showed the expected increase in body weight.
No clinical signs of toxicity were observed.

Any other information on results incl. tables

The vehicle alone caused no skin reactions at any timepoint and in any animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information and not classified according to EU classification criteria Criteria used for interpretation of results: EU