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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:
not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In deviation of the current OECD TG, occlusive treatment was used in the study. This can be considered a "worst case" situation, and does not impair the reliability of the test results.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
1) test performed under occlusive conditions (instead of semi-occlusive)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Carbon black (Farbruss FW 200, Degussa AG), batch: Kontroll-Nr. 32A; not specified further.

Test animals

Species:
rabbit
Strain:
other: White Russian
Details on test animals and environmental conditions:
TEST ANIMALS: albino rabbits, White Russian strain, from Asta-Werke AG, Bielefeld/Germany (breeder), average weight 2.0-2.2 kg, age 5 months. Male and female animals were used for the study.
HOUSING:stainless steel cages, 1 animal/cage, standard diet (Altromin), water ad lib., temperature 22 +/- 1 deg C, relative humidity 50-60%, 12 hours artificial light/12 hours dark, the laboratory and cages were cleaned with standard disinfectants, instruments and equipment were sterilized. Food was withdrawn on the day of application.
ADAPTATION PERIOD BEFORE STUDY BEGIN: 1 day.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: untreated and abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
EXPOSURE TO THE TEST SUBSTANCE: 0.5 g of the test substance were moistened with 2.5 mL of demineralized water and applied to the intact and scarified back skin of 3 rabbits. The test substance was applied on linen patches and held in contact with the clipped skin under occlusive conditions. The skin of one side of the back of each animal was superficially scarified avoiding deeper injury and bleeding.
Duration of treatment / exposure:
EXPOSURE TIME: 4 hours
Observation period:
OBSERVATIONS: the skin was evaluated for edema and erythema at 1, 24, 48 and 72 hours after removal of the patches. All animals were also observed for clinical signs of systemic toxicity. SCORING: According to Draize.
Number of animals:
3/group
Details on study design:
in accordance with current testing guidelines, except for occlusive dressing

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
other: intact skin
Irritant / corrosive response data:
None of the animals exhibited any signs of skin irritation (no edema, no erythema at any of the observations).
Other effects:
No signs of systemic toxicity were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not irritating