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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Saturnová šeď LCG: 95.2 % (w/w)black powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS - Source: Spolek chovatelů Hradec Králové, Czech Republic - Weight at study initiation: > 2.5 kg - Housing: individual cages without bedding, monitored conditions - Diet (e.g. ad libitum): standard granular feed (for rabbits and guinea pigs) ad libitum - Water (e.g. ad libitum): tap water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 ± 2°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 g of the test substance
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE - Area of exposure: 6×6 cm - Type of wrap if used: gauze, aluminum foil and cotton wool REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 4 hoursOBSERVATION TIME POINTS1, 24, 48 and 72 hours SCORING SYSTEM: Erythema and edema four-point scale according to OECD guideline.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, Direct Black 112, is not irritant to skin according to conditions listed in Regulation (EC) 1272/2008 (CLP).
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
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Saturnová šeď LCG: 95.2 % (w/w)black powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS - Source: Spolek chovatelů Hradec Králové, Czech Republic - Weight at study initiation: > 2.5 kg - Housing: individual cages without bedding, monitored conditions - Diet (e.g. ad libitum): standard granular feed (for rabbits and guinea pigs) ad libitum - Water (e.g. ad libitum): tap water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 ± 2°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE - Washing (if done): yes - Time after start of exposure: 24 hours SCORING SYSTEM: According to OECD Guidelinr 405 TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: average score: 0.667
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: average score: 0.333
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: average score: 1.000
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: average score: 0.333
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: average score: 0.333
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1 - 2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: average score: 1.667
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1 - 2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: average score: 1.667
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, Direct Black 112, is not irritant to eyes according to conditions listed in Regulation (EC) 1272/2008 (CLP).
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

The results, presented in the older but well documented assays, were interpreted in accordance with classification rules in the Regulation (EC) No. 1272/2006 (CLP). According to these rules the test substance does not fulfil the criteria for eye and skin irritation, as neither mean score of skin/eye damage nor number of affected animals does not meet the requirement for classification, so the test substance can be considered as no eye irritant, no skin irritant.