Registration Dossier

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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Purity unknown, limited description of the method, test period unknown
Guideline:
other: Barail test with intracutaneous injection
GLP compliance:
no
Species:
rabbit
Strain:
other: Gelb-Silber
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Sesame oil
Duration of treatment / exposure:
Daily exposures over five days of 0.5mL of 5 or 10% C.I. Pigment Orange 5 in sesame oil to clipped rapid skin.
Observation period:
5 days
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 5 days
Score:
ca. 0
Remarks on result:
other: Daily exposures over five days with 0.5mL of 5 or 10% of C.I. Pigment Orange 5 in sesame oil to clipped rabbit skin didn’t show any skin reactions.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Daily exposures over five days with 0.5mL of 5 or 10% of C.I. Pigment Orange 5 in sesame oil to clipped rabbit skin didn’t show any skin reactions.
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:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Gelb-Silber
Vehicle:
other: Sesame oil
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
Single exposure of 0.1 mL of 5 or 10% suspension of C.I. Pigment Orange 5 in sesame oil
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 to 7 hours
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight redness after 3 to 7 hours was observed for three rabbits exposed to the highest concentration of 10% of C.I. Pigment Orange 5 in Sesame oil. The redness was not observed after 24 hours, and the rabbit of 5% dilution showed no reaction.
Other effects:
Very slight redness after 3 to 7 hours was observed for three rabbits exposed to the highest concentration of 10% of C.I. Pigment Orange 5 in Sesame oil. The redness was not observed after 24 hours, and the rabbit of 5% dilution showed no reaction.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Most relevant study

Justification for selection of eye irritation endpoint:
Most relevant study

Justification for classification or non-classification

Studies investigating skin, eye or respiratory tract irritation did not reveal any or – if at all – only minimal evidence of irritant potential of Monoazo Red Pigments, which were fully reversible. Therefore, Monoazo Red Pigments of this category have not to be classified as skin, eye or respiratory tract irritants according to Regulation (EC) No 1272/2008 and Council Directive 67/548/.