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Description of key information

Skin Irritation = non irritant

Eye irritation = not irritant

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 December 17 to January 9, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test conducted according to internationally accepted testing guideline.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS
- Age at study initiation: 2-3 kg
- Weight at study initiation:
- Housing: metal cage
- Diet: standard rabbit food - NAFAG ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod : 10 hours light cycle dark/light

Type of coverage:
occlusive
Preparation of test site:
other: shaved and scarified
Vehicle:
other: propylene glycol + saline (70 : 30 parts)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g of the test material
- Concentration: 50 %

Duration of treatment / exposure:
24 hour
Observation period:
7 days
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.



Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: shaved and abraded
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: shaved and abraded

Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Evaluation of the skin reactions

TIME After 24 h After 49 h After 72 h
SEX MALE FEMALE MALE FEMALE MALE FEMALE
Animal N° 164 165 166 167 168 169 164 165 166 167 168 169 164 165 166 167 168 169
Erythema a 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Edema a 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Total a 2 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Mean a 0.6 0.6 0 0 0 0
b 0 0 0 0 0 0
Group mean a 0.6 0 0
b 0 0 0
TIME After 4 days After 7 days
SEX MALE FEMALE MALE FEMALE
Animal N° 164 165 166 167 168 169 164 165 166 167 168 169
Erythema a 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0
Edema a 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0
Total a 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0
Mean a 0 0 0 0
b 0 0 0 0
Group mean a 0 0
b 0 0

mean reaction score
time after exposure erythema edema
intact
skin
abraded
skin
intact
skin
abraded
skin
24 0.3 0 0.3 0
72 0 0 0 0
total 0.3 0 0.3 0 0.6
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was found to cause no irritation when applied to intact and abraded rabbit skin.
Executive summary:

The substance has been tested According to EPA OPP 81 -5 guideline. Under the conditions of the present experiment the test item was

found to cause no irritation when applied to intact and abraded rabbit skin according to the Regulation EC n. 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:
October 3, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test conducted according to internationally accepted testing guideline.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: IVANOVAS
- Weight at study initiation: 2-3 kg
- Housing:individually in metal cages
- Diet: rabbit food - NAFAG, No. 814, Gossau SG ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g

After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline
Duration of treatment / exposure:
After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline
Observation period (in vivo):
The rabbits were examined 1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
The test was performed on 3 male and 3 female adult rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes

TOOL USED TO ASSESS SCORE:
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was found to cause no irritation when applied to the rabbit eye mucosa.
Executive summary:

The substance has been tested for eye irritation according to (EPA) § 163.81-4 "Primary eye irritation study". According to the Regulation EC n. 1272/2008 the test material was found to cause no irritation when applied to the rabbit eye mucosa.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acid Yellow 151 shows a minimal interaction with skin and eye rabbit during the tests.

Justification for selection of skin irritation / corrosion endpoint:

Study conducted according to internationally accepted testing procedure. The test made in the 1979 is more detailed than the 1976 study.

Justification for selection of eye irritation endpoint:

Study conducted according to internationally accepted testing procedure. The test made in the 1979 is more detailed than the 1976 study.

Justification for classification or non-classification

Based on the Regulation EC n. 1272/2008 eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application. All study results indicates that Acid Yellow 151 shows a minimal interaction with eye. No classification is necessary.

Based on the Regulation EC n. 1272/2008, table 3.2.2 (concerning skin irritation) the results are to low for classification and are fully reversible within 24h. No classification is necessary.