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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 / corrosion (KEY_404_1990_RCC_263968): not corrosive, not irritant
Eye irritation (KEY_405_1990_RCC_263957): not irritant
Respiratory irritation: no study available

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.4 - 2.9 kg, female 2.9 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum
- Acclimation period: Four days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): relative humidity 40-70%,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg / animal
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the test article was covered with a 3.0 cm x 3.0 cm 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.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 4h

SCORING SYSTEM: ERYTHEMA AND ESCHAR FORMATION score 0-4, EDEMA FORMATION score 0-4
Irritation parameter:
erythema score
Basis:
animal: # 71
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
erythema score
Basis:
animal: # 72
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
erythema score
Basis:
animal: # 73
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
edema score
Basis:
animal: # 71
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
edema score
Basis:
animal: # 72
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
edema score
Basis:
animal: # 73
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritant / corrosive response data:
no signs of irritaion at any time point
Other effects:
In the area of application orange staining of the treated skin attributed to the pigment or coloring of the test article was observed in all animals at any of the examination intervals.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All calculated scores (mean of 24, 48 and 72 h) were of grade 0.00.
The test item is not subject to classification and labelling.
Executive summary:

The test item was tested for primary skin irritation according to OECD TG 404.

Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.00, when applied to intact rabbit skin. Local signs (mean of 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. In the area of application, orange staining of the treated skin by pigment or co1oring ef the test article was observed in all animals at any of the examination intervals. No corrosive effect had occurred on the skin at any measuring interval.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute 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: SAVO, med. Versuchstierzuchten GmbH, Stolzenseeweg 32-36, D-7964 Kisslegg im Allgäu
- Age at study initiation: male 14 weeks, female 15 weeks
- Weight at study initiation: male 2.4 kg, female 2.4 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: Four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): relative humidity 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as reference control
Amount / concentration applied:
100 mg / animal
Duration of treatment / exposure:
once
Observation period (in vivo):
examination 1, 24, 48 and 72 hours after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM:
- CORNEAL IRRITATION: 0-4
- IRIDIC IRRITATION: 0-2
- CONJUNCTIVAL Redness: 0-3
- CONJUNCTIVAL Chemosis: 0-4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation were fully reversible within 24 h
Irritant / corrosive response data:
No corrosion was observed at any of the measuring intervals.
Other effects:
Orange staining of the eyelashes of the treated eyes by coloration of the test article was observed in all animals until termination of test.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All calculated mean scores were well below the threshold for classification.
Therefore the test item is not subject to classification and labelling.
Executive summary:
The test item was tested for primary skin irritation according to OECD TG 405.

 

Under the conditions of this experiment, the test item was found to cause mean primary irritation scores of 0.0 for cornea, iris, and conjunctivae chemosis. Mean primary irritation scores for conjunctivae redness were 0.3 in two and 0.0 in one rabbit. No corrosion was observed at any of the measuring intervals. Orange staining of the eyelashes of the treated eyes by coloration of the test article was observed in all animals until termination of test. All signs of irritation were fully reversible within 48 h.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
well performed GLP and OECD guideline study / no other study available

Justification for selection of eye irritation endpoint:
well performed GLP and OECD guideline study / no other study available

Justification for classification or non-classification

No relevant signs of irritation or corrosion were observed when testing for Eye- and Skin irritation/corrosion in rabbits. The mean scores (mean of 24, 48, 72h) of all animals were either 0 or 0.33 (2 cases of conjunctivae redness) and thus beeing far below the threshold for classification.

Therefore Pigment Orange 74 is considered not to be irritant or corrosive to skin or eyes and has not to be classified regarding irritation/corrosion according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008.