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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 an Acute Dermal Irritation/Corrosion study in rabbits with C.I. Pigment Red 194 neither erythema nor edema were observed at any reading time in any animal. The test was performed before OECD and GLP guidelines according to FDA-guideline 1973. Important aspects (dosing, observation times, grading criteria) are comparable with current OECD guidelines. Therefore, C.I. Pigment Red 194 has to be regarded as not skin irritating/corrosive.


 


Eye irritation:


In an Acute Eye Irritation/Corrosion study in rabbits with C.I. Pigment Red 194 . The test was performed before OECD and GLP guidelines according to FDA-guideline 1973. Important aspects (dosing, observation times, grading criteria) are comparable with current OECD guidelines. Observed signs of irritation (chemosis, conjunctivae) had been not fully reversible during shortened observation period of 72 hours, but were considered to be fully reversible within a prolonged observation period. Therefore, the test item C.I. Pigment Red 194 has to 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:
according to current guidelines (OECD 404) solid materials should be moistened.
Qualifier:
according to guideline
Guideline:
other: Determination of irritation index according to Federal Register 38, No. 187, 27. 9. 1973, p 27019, § 1500.41
Deviations:
no
GLP compliance:
no
Remarks:
pre-guideline study
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 1,5 - 2,0 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 ad libitum
- Water: tap water ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: shaved intact or shaved abraded with a scarifying instrument
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
examinations: 24, 48 and 72 h after application, i.e. 0, 24, 48 h after the end of treatment/exposure
Number of animals:
6
Details on study design:
0.5 g of the undiluted test substance 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. Reactions are recorded 0, 24 and 48 h after the end of exposure.

Irritation parameter:
edema score
Basis:
animal: # 1-6 each
Time point:
other: mean of 0, 24, 48 h after the end of exposure
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal: # 1-6 each
Time point:
other: mean of 0, 24, 48 h after the end of exposure
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Remarks on result:
other: intact and abraded skin
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:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions.
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions.
Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 Himalaya rabbits according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were examined 0, 24, and 48 h after the end of exposure. 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
Qualifier:
according to guideline
Guideline:
other: Federal Register Vol 38, no 187, S. 27019, 1973
Deviations:
no
GLP compliance:
no
Remarks:
pre-guideline study
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 1,5 - 2,0 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 ad libitum
- Water: tap water ad libitum

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as control respectively
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 h, rinsing with physiol. saline 24 h after instillation
Observation period (in vivo):
examinations at 1, 7, 24, 48, 72 h after instillation
Number of animals or in vitro replicates:
6
Details on study design:
Application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively

- Instillation: 100 mg of the undiluted substance

- Washing: Washing with physiological saline 24 h after administration

- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium, under UV light

The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, and 72 hours.
Irritation parameter:
cornea opacity score
Basis:
animal: # 1-6 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation (cornea) in 2 animals were fully reversible within 24 h
Irritation parameter:
iris score
Basis:
animal: # 1-6 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: # 1 - 6 each
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Remarks on result:
other: considered to be fully reversible within a prolonged observation period
Irritation parameter:
chemosis score
Basis:
animal: # 1, 2, 4, 5 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Remarks on result:
other: considered to be fully reversible within a prolonged observation period
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean of 24, 48, 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
discharge in all animals until 24 h and still existing in 2 animals at the end of the observation period after 72h.
Other effects:
no other effects reported
Interpretation of results:
GHS criteria not met
Remarks:
the slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008
Conclusions:
The test material is slightly irritating to the eyes under the test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. All animals showed a conjunctiva redness score of one until the end of the 72 h observation period. Conjunctiva chemosis score was fully reversible within 72 h for all animals except one.
Based on the slightness of the observed conjunctival effects and because of their proceeding recovery full reversibility is expected in the course of a prolonged recovery period in all animals.
Therefore, the slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. Different effects could be observed. Conjunctiva redness score of 1 in all animals at all reading time points, which was not fully reversible within 72 h. Conjunctiva chemosis score of 1 was not fully reversible after 72 h in 1 animal. Slight discharge was still existent in 2 animals after 72 h.

Based on the slightness of the observed conjunctival effects and because of their proceeding recovery full reversibility is expected in the course of a prolonged recovery period in all animals.

No effects on cornea and iris were observed at reading time points 24, 48 and 72 h.

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 classification or non-classification

Skin irritation/corrosion:

Mean scores (mean of the 24/48/72 h reading calculated for each animal) for erythema and oedema were below the threshold for classification.

Therefore, the test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008.

Eye irritation/corrosion:

Mean scores (mean of the 24/48/72 h reading calculated for each animal) for conjunctivae, cornea, and iris were below the threshold for classification.

Therefore, test item has not to be classified for eye irritation/corrosion according to Regulation (EC) No 1272/2008.