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Diss Factsheets

Administrative data

Description of key information

Skin irritation/Corrosion:


Pigment violet 19 (nano and not specified form): not irritating


 


Eye irritation:


Structure analogue: Pigment violet 19 (nano form): not irritating (OECD 405)


 

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:
From 2 APR 1979 to 5 APR 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Federal Register 38, No. 187, 27.9.1973)
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in house breeding (Hoe:HIMK(SPFWiga))
- Weight at study initiation: 1.5 to 2.5 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westfalen, Germany), ad libitum
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped, partially scarified
Vehicle:
other: polyethylene glycol 400
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of test substance pasted with 0.7 mL of of PEG400

Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: occlusive elastic bandage
- test item was applied to intact as well as scarified skin of each animal

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: result for intact as well as scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: result for intact as well as scarified skin
Irritant / corrosive response data:
- none of the animals showed oedema or erythema at the intact or scarified skin at any time point (immediately, 24 and 48 hours after end of exposure)
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. This conclusion is legitimate although the testing regime differs from today's standard methods (e.g., exposure of intact and scarified skin, application period 24 hours instead of 4 hours, deviating reading times, scoring system is identical to the currently used system), because no skin reactions were observed in any animal at any timepoint. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 Himalayan albino rabbits according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance (pasted in 0.7 mL PEG 400) for 24 h under occlusive conditions and the skin responses were watched for up to 48 hours after 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
Study period:
From 2 AUG 1988 to 5 AUG 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst Ag, Kastengrund, conventional breeding
- Age at study initiation: approx. 3 to 5 months
- Weight at study initiation: 3.2 to 3.7 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g/d
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological solution of sodium chloride (37 °C)
- Time after start of exposure: 24 h (and at every reading when discharge of the eyes occurred or sodium-fluorescein was used for scoring)

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application.
- No effects on cornea, iris, or chemosis occurred (score 0 at every time point)
Other effects:
There was discharge observed in all animals one hour after instillation of the test material.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 3 rabbits according to OECD TG 405. No corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

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

No classification

The test material was not irritant to skin and eyes in in vivo assays in rabbits.