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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study was performed prior to OECD guideline and GLP but follows principles thereof.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
study prior to GLP requirements

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually
- Diet: ad libitum, K12, Ssniff, Germany
- Water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 + 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 h exposure time, after 4h, dressing was removed and skin was washed with water
Observation period:
up to 21 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: gauze and polyethxlen foil, fixed with elastic bandage


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


SCORING SYSTEM: OECD Guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
3.3 - 4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: dark brown-reddish, hard scab or thinner eschar formation. From day one fur growth, from day 13. day detaching of the scab from outer side
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.33 - 2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
5.21
Max. score:
8
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: single means: 1h: 4.67, 24h: 4.17; 48h: 6.0, 72h: 6.0
Irritant / corrosive response data:
after 48h to 72h post exposure, erythema score 4 were observed in all animals
dark brown-reddish, hard scab or thinner eschar formation. From day one fur growth, from day 13. day detaching of the scab from outer side
Other effects:
no systemic effects were reported

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under conditions tested, the test substance showed severe effects on the skin after 4h exposure and is therefore considered to be corrosive.