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Diss Factsheets

Administrative data

Description of key information

Not irritating to rabbit skin and eyes (OECD 404 and 405, GLP).

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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: 4235
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 14 weeks (males) - 15 weeks (female)
- Weight at study initiation: males 2.6 - 2.7 kg, female 2.8 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/19

IN-LIFE DATES: From: 1989-04-04 To: 1989-04-07
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: petrolatum oil (for moistening)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 cm x 10 cm
- Type of wrap if used: patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped
around the abdomen and anchored with an elastic bandage.

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects
Other effects:
In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed during the whole observation period.

No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
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:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: 4235
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: males 2.5 kg, female 2.8 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-04-04 To: 1989-04-07
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: A slit-lamp 30 SL/M (C. Zeiss AG, Zuerich / Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel /
SWitzerland) were both used
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable, as no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable, as no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
3
Reversibility:
other: not applicable, as no effects
Other effects:
Red staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all three animals from 1 hour to 72 hours after the test article application.
No corrosion was observed at any of the measuring intervals.

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

The body weight gain of all rabbits was similar.

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

Pigment Red 214 was evaluated in GLP and OECD 404 and 405 compliant studies in rabbits (RCC 1989). No indication of erythema or erythema was observed on skin. Also, no effects were observed on iris, cornea and conjunctivae. Overall, no adverse signs of toxicity were observed. Absence of irritating properties on skin and in eyes was reported in a poorly documented study (Andrysova 1978). Pigment Red 214 is not irritating to skin and eyes.

 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

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 skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).