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Administrative data

Description of key information

Skin irritation:
In a OECD guideline and GLP compliant primary skin irritation test in rabbits, the test item (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, Pigment Red 112 was regarded as not skin irritating.


Eye irritation:
In a OECD guideline and GLP compliant primary eye irritation test in rabbits, the test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Pigment Red 112 was regarded as not eye irritating.

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:
12 July - 15 July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed in accordance with OECD and GLP guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 3.0 kg to 3.9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethyleneglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 ml PEG 400 to moisten the test item
- Lot/batch no. (if required): not stated
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was cautiously removed
- Time after start of exposure: 4 hours

SCORING SYSTEM:
as described by Draize [identical to EU Method B.4] assessed approximately 30 - 60 min, 24, 48, and 72 h after the romoval of the test item
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritant / corrosive response data:
Scores (oedema or erythema) were 0 at 24, 48 and 72 h after removal of dressing in all animals.
Other effects:
Weak pink staining produced by the test item was present at the 30-60-minute and the 24-hour readings.
Interpretation of results:
GHS criteria not met
Conclusions:
1272/2008/EC: Skin irritation: no classification warranted

In a OECD guideline and GLP compliant primary skin irritation test in rabbits, the test item (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, the test item (Pigment Red 112) was regarded as not skin irritating.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals until the 24 -hour reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant irritative or irreversible damage to the skin. Therefore, Permanent-Rot FGR 02 is considered to be "not irritating" to rabbit skin.

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:
21 July - 15 July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with OECD and GLP guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 2.9 kg to 3.2 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
other: polyethyleneglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
One administration 24 hours
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since on effects occured
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: grade 1 chemosis was observed in all animals at 1 hour and was fully reversible within 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The score refers to redness of conjunctiva, which was evident in all animals 1 h after treatment (score 1 in all 3 animals). The value of 0.11 is the mean (of the three assessments at 24, 48 and 72 h) for all animals combined as well as for each individual animal. At 48 and 72 h, this score was 0 in all animals. Other parameters examined (opacity of cornea, iris, chemosis of conjunctiva) showed scores of 0 at the relevant time points.
Other effects:
Red staining of eye discharge was observed at 1 hour after application. (red test material!)
Interpretation of results:
GHS criteria not met
Conclusions:
1272/2008/EC: Eye irritation: no classification warranted

In a OECD guideline and GLP compliant primary eye irritation test in rabbits, Test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Test item (Pigment Red 112) was regarded as not eye irritating.
Executive summary:

In a OECD 405 guideline and GLP compliant primary eye irritation test in rabbits, Test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Test item (Pigment Red 112) was regarded as not eye irritating.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The results of the skin irritation key study (Hoechst, 1983) are supported by several other primary skin irritation tests in rabbits (Hoechst, 1979a; 1979b; 1979c; Ciba-Geigy, 1972; Reseach Institute for Organic Syntheses, 2007) showing only very slight to mild, transient irritating effects on rabbit skin under the study conditions. In all studies, the strength of the reactions was well below classification-relevant thresholds. The fact that the observation period was not prolonged until full reversibility was achieved in one study in which in one animal a grade 1 reaction was still observed at 72 hours (end of observation period) is not considered relevant for the classification decision because the irritation effects were clearly subsiding over the observation period and the substance was clearly non-irritating in all other studies.

The results of the eye irritation key study (Hoechst, 1983) are reported by several other primary eye irritation tests in rabbits (Hoechst, 1979a; 1979b; 1979c; Ciba-Geigy, 1972; Reseach Institute for Organic Syntheses, 2007) showing either no, very slight or mild to moderate, transient irritating effects on the rabbit eye under the study conditions. In all studies, the strength of the reactions was well below classification-relevant thresholds. The fact that the observation period was not prolonged until full reversibility was achieved in one study in which grade 1 reactions were still observed at 72 hours (end of observation period) is not considered relevant for the classification decision because the irritation effects were clearly subsiding over the observation period and the substance was clearly non-irritating in all other studies.

Justification for classification or non-classification

Pigment Red 112 has been tested in vivo for irritative properties in several skin irritation tests in rabbits. The red substance caused only slight, transient redness to the skin. 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 EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC). Therefore, Pigment Red 112 does not have to be classified as skin irritating.

 

Pigment Red 112 has been tested in vivo for irritative properties in several eye irritation tests in rabbits. The substance caused no or no irritation to the eyes. 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 EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC). Therefore, Pigment Red 112 does not have to be classified as eye irritating.

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