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Description of key information

Based on human experience, carbon black dust or powder may cause drying of the skin with repeated and prolonged contact. As superficial foreign bodies, carbon black particles may be slightly irritating mechanically and may cause discoloration of lids and conjunctivae in humans. Based on available information, untreated nanoforms of carbon black are not irritating to skin and eyes as evidenced by Driaze tests in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
1) test performed under occlusive conditions (instead of semi-occlusive conditions), 2) exposure for 24 hours (instead of 4 hours)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS: albino rabbits, New Zealand White strain, average weight between 2.3 and 2.8 kg. 6 male and 6 female animals were used for the study
HOUSING: stainless steel cages, 1 animal/cage, standard laboratory diet (Altromin), tap water ad lib., room temperature 21 +/- 2 deg C, relative humidity 60 +/- 3%, 12 hours artificial light/12 hrs darkness
ADAPTATION PERIOD BEFORE STUDY BEGIN: not reported
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 dissolved in distilled water at a concentration of 20%, and 0.5 mL of this solution was applied to the intact and scarified back skin of three rabbits, respectively
Duration of treatment / exposure:
EXPOSURE TIME: 24 hours
Observation period:
OBSERVATIONS: the skin was evaluated for edema and erythema at removal of the test substance, and again at daily intervals until study end at 14 days after exposure. The skin was evaluated by two independent investigators. In addition, clinical signs, behaviour, general condition and food consumption was recorded. Body weights were determined daily.
SCORING: According to Draize
Number of animals:
3/group
Details on study design:
in accordance with current testing guideline, except for 24 hours occlusive dressing
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: also at 120h, abraded and intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: also at 120h, abraded and intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: also at 120h, abraded and intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: also at 120h, abraded and intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: also at 120h, abraded and intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: also at 120h, abraded and 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. Behaviour, general condition, and body weight gain were not affected by treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
not irritating
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:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
1) test performed under occlusive conditions (instead of semi-occlusive conditions) 2) exposure period was 24 hours (instead of 4 hours)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS: albino rabbits, New Zealand White strain, average weight between 2.3 and 2.8 kg. 6 male and 6 female animals were used for the study
HOUSING: stainless steel cages, 1 animal/cage, standard laboratory diet (Altromin), tap water ad lib., room temperature 21 +/- 2 deg C, relative humidity 60 +/- 3%, 12 hours artificial light/12 hrs darkness.
ADAPTATION PERIOD BEFORE STUDY BEGIN: not reported.
Type of coverage:
occlusive
Preparation of test site:
other: untreated and abraded
Vehicle:
other: olive oil
Controls:
not required
Amount / concentration applied:
Concentration: 27 % active substance
EXPOSURE TO THE TEST SUBSTANCE: 0.5 g of the test substance were dissolved in pharmaceutical grade olive oil (the maximum attainable concentration was 27%) and applied to the intact and scarified back skin of six rabbits, respectively. The test substance was applied on linen patches and held in contact with the clipped skin under occlusive conditions. In 6 animals, the skin was superficially scarified avoiding deeper injury and bleeding.
Duration of treatment / exposure:
EXPOSURE TIME: 24 hours.
Observation period:
OBSERVATIONS: the skin was evaluated for edema and erythema at removal of the test substance, and again at daily intervals until study end at 14 days after exposure. The skin was evaluated by two independent investigators. In addition, clinical signs, behaviour, general condition and food consumption was recorded. Body weights were determined daily. SCORING: According to Draize.
Number of animals:
6 / group
Details on study design:
in accordance with current testing guidelines, except for 24-hours occlusive dressing
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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. Behaviour, general condition, and body weight gain were not affected by treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
not irritating
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
GHS criteria not met
Conclusions:
not an eye irritant
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
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.
HOUSING:stainless steel cages, 1 animal/cage, standard diet (Altromin), water ad lib., temperature 21 +/- 2 deg C, relative humidity 60 +/- 3%, 12 hours artifical light/12 hours dark
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
undiluted
Amount applied: 100 mg
Duration of treatment / exposure:
24 hour(s)
EXPOSURE TO THE TEST SUBSTANCE: 100 mg of the test substance was instilled into the left eye. The other eye served as control. In 5 animals, the test substance was washed out of the eye after 5 minutes. In 3 animals the test substance was washed out of the eye after 24 hours.
Observation period (in vivo):
OBSERVATIONS: eyes were evaluated for erythema, edema, and effects on cornea and iris according to the Draize score 5 minutes before instillation, and at 24, 48, 72 and 96 hours after instillation. The eyes were evaluated independently by two examiners.
Number of animals or in vitro replicates:
8
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
8 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
8 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
8 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
8 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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:
GHS criteria not met
Conclusions:
not an eye irritant
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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.