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:
1983
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
other: Albino-Neuseeländer
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Polyethylenglycol 400
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h
Score:
>= 0 - <= 1
Max. score:
0.1
Reversibility:
fully reversible within: 24 hours
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not skin irritating or corrosive according to the study result
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)
Rationale for reliability incl. deficiencies:
other: Pigment Red 3 with an unknown additive (0.4%) and unknown impurities concentrations
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: Albino-Neuseeländer
Vehicle:
other: Polyethyleneglycol 400
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
<24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Not irritating in rabit eyes
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:
Four out of five studies showed no adverse effects. One study showed that the test item was "slightly irratating" but the reliability was low due to unknown purity, method, and non CLP condition.

Justification for selection of eye irritation endpoint:
Four out of five studies showed no adverse effects. One study showed that the test item was "slightly irratating" but the reliability was low due to unknown purity, method, and non CLP condition.

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/.