Registration Dossier

Administrative data

Description of key information

Carbon black is not irritating to the skin and eyes of rabbits. As superficial foreign bodies, carbon black particles may be slightly irritating mechanically and may cause discoloration of lids and conjunctivae in humans.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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 Food was withdrawn on the day of application.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.
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
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.
Interpretation of results:
GHS criteria not met
Conclusions:
not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: albino rabbits, New Zealand strain, average weight 2.3-2.8 kg. 3 male, and 3 female animals.
HOUSING: stainless steel cages, 1 animal/cage, standard diet (Altromin), water ad lib., temperature 21 +/- 2 deg C, relative humidity 60 +/- 3%, 12 hours artificial light/12 hours dark.
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
undiluted
Amount applied: 100 mg
Duration of treatment / exposure:
EXPOSURE TO THE TEST SUBSTANCE: 100 mg of the test substance was instilled into the left eye. The other eye was treated with physiological saline solution and served as control. The eyes were not rinsed.
Observation period (in vivo):
OBSERVATIONS: eyes were evaluated for erythema, edema, and effects on cornea and iris according to the Draize score at 24, 48, 72 and 96 hours after instillation.
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritant effects were found in any of the animals at any observation (scores for cornea, iris and conjunctivae: 0.0, 0.0, 0.0).
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
not an eye irritant
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Not classifiable according to the criteria as laid down in the CLP Regulation.