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Diss Factsheets

Administrative data

Description of key information

Skin sensitization:

Testing for sensitizing properties of C.I. Pigment Orange 68 was performed in a guinea pig maximization test with 12 male and 12 female guinea pigs according to OECD guideline 406.

No skin reactions, mortalities or toxic effects could be observed. Therefore, the test item is considered to possess no skin sensitizing potential to albino guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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
Remarks:
according to OECD 406
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
the study was conducted in 1982
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain specifics: Dunkin-Hartley albino guinea pig
- Source: Sueddeutsche Versuchstierfarm, Tuttlingen Germany
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: males 354 - 495 g; females 401 - 589 g
- Acclimation period: 1 week under test conditions
- Housing: individually in Macrolon cages type III with wire mesh tops and standardized granulated soft wood bedding
- Diet (e.g. ad libitum): pelleted standard KLIBA 23/342/1 guinea pig breeding/maintenance diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal
Vehicle:
other: physiological saline, propylene glycol, Freund's Adjuvant, white vaseline
Route:
intradermal
Concentration / amount:
INDUCTION EXPOSURE:
1st week: 0.1 % test substance in physiological saline plus propylene glycol (1:1) and the solvent negative control
0.1 mL were injected respectively

2nd and 3rd week: test substance dissolved in a mixture of physiological saline plus plus propylene glycol (1:1) plus Freund's Adjuvant
0.1 mL were injected respectively

CHALLENGE EXPOSURE:

intradermal: 0.1 % test substance in physiological saline plus propylene glycol (1:1)
0.1 mL were injected respectively
epicutaneous: 30 % test substance in soft white vaseline, equal amount per 2 x 2 cm patch applied
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
Route:
intradermal and epicutaneous
Vehicle:
other: physiological saline, propylene glycol, Freund's Adjuvant, white vaseline
Route:
intradermal
Concentration / amount:
INDUCTION EXPOSURE:
1st week: 0.1 % test substance in physiological saline plus propylene glycol (1:1) and the solvent negative control
0.1 mL were injected respectively

2nd and 3rd week: test substance dissolved in a mixture of physiological saline plus plus propylene glycol (1:1) plus Freund's Adjuvant
0.1 mL were injected respectively

CHALLENGE EXPOSURE:

intradermal: 0.1 % test substance in physiological saline plus propylene glycol (1:1)
0.1 mL were injected respectively
epicutaneous: 30 % test substance in soft white vaseline, equal amount per 2 x 2 cm patch applied
No. of animals per dose:
Vehicle control group vaseline pure: 24 animals
Treatment group: 24 animals

Details on study design:
MAIN STUDY:

A. INDUCTION EXPOSURE
- No. of exposures: injections on days 1, 3, 5 in the 1st week, on days 8, 10, 12 and 15, 17, 19 in the 2nd and 3rd week
- Site: shaved flank for intradermal injections
- Concentrations: see above

B. CHALLENGE EXPOSURE
- No. of exposures: 1 intradermal injection, 1 epicutaneous exposure
- Day(s) of challenge: day 32 of study
- Site: untreated flank
- Concentrations: primary non irritant concentration 30 % epicutaneous, 0.1 % intradermal
- Evaluation (hr after challenge): 24 h after intradermal challange, 24 h after 24 h lasting epicutaneous challange treatment
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene
Positive control results:
in a separate test the incidence of the guinea pig strain to allergic reactions was tested with the known allergen dinitrochlorobenzene. Significant positive results were obtained in all animals with this compound.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 %
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
no positive reactions observed
Remarks on result:
other: Reading: other: reading after first challange (intradermal). . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 24.0. Clinical observations: no positive reactions observed.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
no positive reactions observed
Remarks on result:
other: Reading: other: reading after first challange (intradermal). . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 24.0. Clinical observations: no positive reactions observed.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
no positive reactions observed
Remarks on result:
other: see Remark
Remarks:
Reading: other: reading after second challange (24 h epicutaneous treatment). . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no positive reactions observed.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
no positive reactions observed
Remarks on result:
other: see Remark
Remarks:
Reading: other: reading after second challange (24 h epicutaneous treatment). . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no positive reactions observed.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guinea pig maximisation test according to OECD 406, the test item did not cause any skin reactions in all 24 animals of the treatment group after challenge exposures. Based on the results of this study the test item has to be regarded as not sensitising.
Executive summary:

Testing for sensitizing properties of the test item was performed in 12 male and 12 female guinea pigs according to OECD guideline 406. Intradermal induction was performed by 9 injections (3 injections weekly) within 3 weeks using a 0.1 % test item preparation. In the 1st week a 1:1 mixture of physiological saline with propylene glycol was applied as vehicle, In the 2nd and 3rd week Freund's Adjuvant was added to the vehicle mixture. After a rest period of 13 days challenge treatment was carried out with 0.1 % test item mixture (1 : 1 physiological saline and propylene glycol, intradermal injection) as well as with 30 % test item in white vaseline (epicutaneous, occlusive). The patches were removed after 24 h. Another 24 animals served as vehicle control group.

No skin reactions, mortalities or toxic effects could be observed. Therefore, the test item is considered to possess no skin sensitisiing potential to albino guinea pigs.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitization:

No skin reactions, mortalities or toxic effects could be observed. Therefore, the test item is considered to possess no skin sensitisiing potential to albino guinea pigs.

Therefore, the test item has not to be classified for skin sensitization according to Regulation (EC) No 1272/2008.