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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation:
In a FDA guideline primary skin irritation test in rabbits with the test item (Pigment Red 168) neither erythema nor edema were observed at any reading time in any animal. In a second,  analogue study, also no skin reactions were observed. Therefore, Pigment Red 168 can be regarded as not skin irritating.
Eye irritation:
In a FDA guideline primary eye irritation test in rabbits with Pigment Red 168 no ocular reactions were observed at any time in any animal. In a second, analogue study, the test item (pigment Red 168) caused slight conjunctivae redness and chemosis. All signs of irritation were fully reversible within 72 h. Therefore, the test item (Pigment Red 168) can be regarded as not eye irritating.
Respiratory tract: 
Based on available data  the substance is considered likely to behave like an inert dust. Consequently the substance is considered not to exert any local irritative effects. Therefore, it is concluded, that testing is not necessary to reach the scientific conclusion that classification is not warrantable.

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:
comparable to guideline study with acceptable restrictions
Remarks:
Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Deviations:
no
GLP compliance:
no
Remarks:
pre-guideline study
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: J. Scheele, Büderich, Germany
- Housing: single caged
- Diet: standard diet Ssniff K 4

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
other: shaved intact or shaved abraded with a scarifying instrument
Vehicle:
other: type vehicle used not specified
Controls:
not required
Amount / concentration applied:
0.5 g of the test item (The amount used is not explicitely specified in the report, but according to the guideline followed 0.5 gram is requested in the case of solids and semisolids) mixed with an appropriate solvent
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
0.5 g of the test substance diluted in an appropriate solvent is spread on a gauze patch, measuring 2,5 x 2,5 cm which is applied on the abraded and intact skin of 6 albino rabbits, clipped free of hair under occlusive conditions. After 24 hours of exposure, the patches are removed and reactions are recorded. Readings are made again 72 hours after application.
(Abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding)

Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reactions were observed in any animal at any timepoint.
Other effects:
no other effects reported
Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008
Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g of the test substance dissolved in an appropriate solvent for 24 h under occlusive conditions and the skin responses were recorded 24 h and 72 after application (i.e. 0 and 48h after patch removal). No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

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:
comparable to guideline study with acceptable restrictions
Remarks:
Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no
Remarks:
pre-guideline study
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: J. Scheele, Büderich, Germany
- Housing: single caged
- Diet: standard diet Ssniff K 4

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: one eye, remaining untreated, serves as a control
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 h (rinsing not explicitelx specified in the report)
Observation period (in vivo):
examinations at 24, 48, 72 h , and 7 days after instillation
Number of animals or in vitro replicates:
6
Details on study design:
100 mg of the test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control.The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours and 7 days. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. Any or all eyes may be washed with sodium chloride solution after the 24-hour reading.
Irritation parameter:
cornea opacity score
Basis:
animal: # 1-6 each
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: # 1-6 each
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
chemosis score
Basis:
animal: # 1-6 each
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (chemosis) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: # 1-6 each
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no signs of irritation (conjunctivae) at any time
Irritant / corrosive response data:
No ocular reactions were observed in any animal at any time.
Other effects:
no other effects reported
Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
Executive summary:

The test material was subject to an acute eye irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. 100 mg test substance were placed into the conjunctival sac of one eye of each rabbit. Reactions were recorded frequently during the observation period of 7 days. No effects were observed for all irritation parameter during the study. Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.

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:
From two equivalent studies with coincident results the posterior was selected as key study.

Justification for selection of eye irritation endpoint:
From two equivalent studies with similar results the posterior was selected as key study.

Justification for classification or non-classification

Pigment Red 168 has been tested in vivo for skin irritative properties in two tests in rabbits. In these FDA guideline compliant studies, the substance did not cause any skin reactions at any time in any animal. Therefore, Pigment Red 168 does not have to be classified as skin irritating according to Directive 67/548/EEC and Regulation (EU) No 1272/2008.

 

Pigment Red 168 has been tested in vivo for eye irritative properties in two tests in rabbits according to FDA guideline. In the key study no signs of irritation were observed at any time. In the supporting study the substance caused only very slight, transient irritation to the eyes which might be attributed to mechnical attrition. The individual and group mean of scores read 1, 2 and 3 days after treatment were well below the classification criteria laid down in the Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, Pigment Red 168 does not have to be classified as eye irritating.

 

It can reasonably be deduced that Pigment Red 168 does not cause respiratory tract irritation and thus does not have to be classified according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, because Pigment Red 168 did cause only very slight, fully reversible irritative effects in the eyes and no skin reactions and does not have to be classified as either skin or eye irritating. Moreover, Pigment Red 168, in the unlikely event of being inhaled as a dust, is considered not to cause more severe effects than an inert dust, because its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.