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Diss Factsheets

Administrative data

Description of key information

The commercial form of the green pigment was tested for skin and eye irritation in rabbits prior to the introduction of GLP and OECD testing guidelines (BASF 1978). The studies were performed according the procedures published in the US Federal Register Vol. 38. The procedure for eye irritation is identical to the later adopted OECD guideline 405, whereas the procedure for skin irritation uses a more stringent 24h occlusive exposure with short observation period of 72h.

In the study for skin irritation, green staining of the skin interfered with erythema staining after 24h and also in some animals after 72h. No erythema were observed in animals for which scoring was possible. No edema was observed at either time point in any animal. After 7 days, the hypoderm and muscle under the treated sites were examined and no adverse findings were observed.

Considering the clear absence of effects, the skin irritation study is suitable to allow the conclusion "not classified" according to GHS criteria.

No findings on rabbit eyes were observed for any parameter (iris, conjuctivae, cornea) at any time point in any animal.

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:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: US Federal Register 38 No 187 § 1500.41
Version / remarks:
24h occlusive exposure, investigation of hypoderm and underlying muscles
GLP compliance:
no
Specific details on test material used for the study:
Heliogengrün 9140
Species:
rabbit
Strain:
other: Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3-4kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least three days

ENVIRONMENTAL CON DITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 34 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
intact and scarified sites were tested on the same animal
Vehicle:
other: 50% Lutrol 400 (= PEG 400) in water
Remarks:
for moistioning
Controls:
other: yes, untreated skin sites
Amount / concentration applied:
0.5g per site (1g per animal)
Duration of treatment / exposure:
24h
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6.25cm2
- Type of wrap if used: PVC foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm vehicle
- Time after start of exposure:24h

OBSERVATION TIME POINTS
24h and 72h for skin findings, 7 days for hypoderm and muscle

SCORING SYSTEM: Draize
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, since no findings
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, since there were no findings
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
24 h
Remarks on result:
not determinable
Remarks:
The green test material had stained the skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, since no findings
Remarks on result:
other: For half of the animals, green staining of the skin interfered with scoring.
Irritant / corrosive response data:
At the end of treatment (24h reading), scoring for erythema was not possible as the green test item had stained the skin.
At the 72h reading, scoring was still not possible for 3 animals. For the other 3 animals, no erythema (score = 0) was observed. Findings were equal for intact and scarified skin.

Edema was not observed in any animal at any time point (Score = 0).
Other effects:
There were no adverse findings on the hypoderm and muscles underlying the treated skin sites.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: US FEDERAL REGISTER 38 NO. 187, Paragraph 1500.42 page 27019 of 27. SEPT. 1973
GLP compliance:
no
Specific details on test material used for the study:
Heliogengrün 9140
Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3 - 4 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 45 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing after application


SCORING SYSTEM: Draize
Time points investigated: 1h, 24h, 72h, and longer if needed

TOOL USED TO ASSESS SCORE: not specified
Irritation parameter:
cornea opacity score
Basis:
other: all six animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, since no findings
Irritation parameter:
iris score
Basis:
other: all six animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable since no adverse findings
Irritation parameter:
conjunctivae score
Basis:
other: all six animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, since no adverse findings
Irritation parameter:
chemosis score
Basis:
other: all six animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable since no adverse findings
Irritant / corrosive response data:
One hour after the application, two rabbits showed slight wetness of the treated eyes.
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

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. Well reported in-vivo studies are available for skin and eye irritation. In both studies, the scores for the test item treated sites / eyes were clearly below the thresholds for classification as an irritant.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 tenth time in Regulation (EU) No 2017/776.