Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Carbon black
EC Number:
215-609-9
EC Name:
Carbon black
Cas Number:
1333-86-4
Molecular formula:
C
IUPAC Name:
Carbon black
Test material form:
solid: nanoform, no surface treatment

Test animals

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

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 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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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