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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The pigment 48:1(Ba) is not irritating to eyes and skin of rabbit (BASF 1974 and Ciba 1973).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Documentation insufficient for assessment of erytheme score, test item colours the skin.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. Exposure of 1, 5 and 15 minutes was not done in this experiment
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): C.I.Pigmentred 48:1, Monoazofarbstoff. / Litholscharlach 3700
- Physical state: solid
- Analytical purity: 100 %
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Gaukler (Breeder)
- Weight at study initiation: female: 2.89 kg, male: 2.97 kg
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution
Duration of treatment / exposure:
20 hours
Observation period:
8 d
Number of animals:
1 female, 1 male
Details on study design:
Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.

TEST SITE
- Area of exposure: dorsal
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: cotton lobe

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Not scorable at 24h due to red staining by the test item
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h and 8 days
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Other effects:
Red substance residues after 24 h. No abnormality and no red substance residues detected after 8 d.
Interpretation of results:
GHS criteria not met
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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Partly limited documentation, only two animals used
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): C.I.Pigmentred 48:1, Monoazofarbstoff.
- Physical state: solid
- Analytical purity: 100%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler (Breeder)
- Weight at study initiation: 2.99 kg (female), 3.0 kg (male)

ENVIRONMENTAL CONDITIONS
not reported
Vehicle:
unchanged (no vehicle)
Controls:
other: talcum (amorph) into the other eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 µl (corresponds to 100 mg)
- Concentration: undiluted
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage, which would probably be less severe if it had been washed out after 1 day.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1 female, 1 male
Details on study design:
SCORES
Descriptive scores of the raw data have been converted to Draize numerical scores

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Other effects:
Red compound residues were observed after one hour
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation was investigated in two rabbit studies (BASF 1974 and Ciba 1973). During the key study, two rabbits were treated with a commercial product for up to 20h using occlusive conditions. No abnormalities were detected at the 1 and 8 day readings (BASF AG 1974), but red residues on the skin interfered with erythema scoring. Very mild erythema and absence of edema were observed at the 24 and 72h reading in a study following the standard procedure of the The Food and Drug Administration of the U.S.A. in The Federal Register (17 September, 1964 § 191.11) (Ciba 1973). This involves 24h occlusive application and represents a worse case than the 4h semi-occlusive application required by the OECD testing guideline for skin irritation. Overall, Pigment Red 48:1 is considered to be non irritating to skin.

 

Assessment of eye irritation was performed in two rabbit studies performed with commercial products according to a protocol similar to OECD testing guideline 405. The main difference is that there are limited details on non-irritation related parameters such as body weight. Slight and transient redness of conjunctivae and no findings on iris and cornea were observed (Ciba 1973, BASF 1974). It is concluded that Pigment Red 48:1 is not irritating to eyes.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.