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Diss Factsheets

Administrative data

Description of key information

The test item (Pigment Yellow 191) was found to be not a skin sensitiser in the GPMT when tested up to 1% (intradermal induction) and 25 % (epidermal induction).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
well performed GLP and OECD guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(GPMT)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Directive 84/449/EEC (GPMT)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1988
Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
-Strain specifics: Hoe: DHPK (SPFLac)
- Source: Hoechst AG breeding colony
- Weight at study initiation: mean 315 g (range: 273-380 g)
- Housing: in groups of five animals in Makrolon type 4 cages with softwood bedding in fully air-conditioned rooms
- Diet (e.g. ad libitum): standard diet Altromin 3112, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light):12/12
Route:
intradermal and epicutaneous
Vehicle:
other: 50 % Freund's Adjuvant in physiological saline / semi-liquid paraffin / perolatum
Concentration / amount:
According to the findings of the intra- and epidermal pretests, the concentrations for the main study were selected.

Intradermal induction (2 x 0.1 mL):
50 % Freund's Adjuvant in physiological saline, injection site 1
1 % (w/v) in semi-liquid paraffin, injection site 2
1 % (w/v) in 50 % Freund's Adjuvant in physiological saline, injection site 3
Epidermal induction:
25 % (w/w) in petrolatum (0.5 mL applied)
Epidermal challenge:
25 % (w/w) in petrolatum (0.5 mL applied)
Route:
epicutaneous, occlusive
Vehicle:
other: 50 % Freund's Adjuvant in physiological saline / semi-liquid paraffin / perolatum
Concentration / amount:
According to the findings of the intra- and epidermal pretests, the concentrations for the main study were selected.

Intradermal induction (2 x 0.1 mL):
50 % Freund's Adjuvant in physiological saline, injection site 1
1 % (w/v) in semi-liquid paraffin, injection site 2
1 % (w/v) in 50 % Freund's Adjuvant in physiological saline, injection site 3
Epidermal induction:
25 % (w/w) in petrolatum (0.5 mL applied)
Epidermal challenge:
25 % (w/w) in petrolatum (0.5 mL applied)
No. of animals per dose:
10 animals in the treatment group of the main test
5 animals in the control group of the main test

5 animals in the concomitant control group

(in case of a questionable result additional animals will be tested to give a total of 20 treatment and 10 control animals)

6 animals for determination of the primary non-irritant concentration
3 animals for determination of tolerance of intradermal injections
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 intradermal injections and 1 epidermal application
- Exposure period: intradermal injections on day 1 and epidermal application on day 9 (occlusive, bandage removed after 48 h)
- Test groups: 3 sites (50 % Freund's Adjuvant in physiological saline only, test substance in semi-liquid paraffin and test substance in 50 % Freund's Adjuvant in physiological saline) per injection, test substance in petrolatum for dermal application
- Control and concomitant control group: 3 sites (50 % Freund's Adjuvant in physiological saline, semi-liquid paraffin and 50 % Freund's Adjuvant in physiological saline) per injection, petrolatum for epidermal application
- Site: dorsal area measuring 2 x 4 cm in the vicinity of the shoulders for intradermal injections, epidermal application covered the same area where the intradermal injections had been placed
- Frequency of applications and duration: see above
- Concentrations: see above

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 15 (concomitant control group) and day 22 (control and treatment group)
- Exposure period: occlusive for 24 h (removal of bandage on day 23)
- Test groups: test substance
- Control group: test substance
- Concomitant control group: test substance

- Site: left flank
- Concentrations: see above
- Evaluation (h after challenge = h after removal of the patch): 24 h and 48 h
Positive control substance(s):
not specified
Positive control results:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Concomitant control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Concomitant control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Concomitant control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Concomitant control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.

No effects on body weight gains were observed. No signs of intoxication were observed except in one animal of the treatment group which was moribund on day 21 and therefore excluded from the challenge exposure. The intradermal injection with Freund's adjuvant physiological saline mixture (with and without test substance) caused severe edema and erythema as well as indurations and encrustations at injection sites. The sites treated with the test substance in Freund's adjuvant physiological saline mixture were discoloured yellow. Intradermal injections of the test substance in paraffin exhibited very slight erythema and were discoloured yellow.

24 and 48 h after removal of the patches neither animals of the treatment group nor of the control showed signs of irritation at the application sites.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guinea pig maximisation test, the test item caused no skin reaction in the animals of the treatment group or in the control animals. Based on the results of this study the test item showed no evidence for sensitising properties.
Executive summary:

Testing for sensitising properties of the test item was performed in female guinea pigs according to the adjuvant sensitisation test by Magnusson and Kligman (OECD TG 406, Guinea Pig Maximisation Test). Intradermal induction was performed using 1 % test item in semi-liquid parrafin or 1 % in a 1: 1 mixture of Freund's Adjuvant and physiological saline. Epidermal induction was carried out with 25 % test item in petrolatum.

Challenge treatment was conducted using 25 % test item in petrolatum with 9 animals in the treatment and 5 animals in the control group (1 moribund animal was excluded at day 21). At the 24 hour and 48 h reading no skin reactions were observed in any animal.

Therefore, the test item has to be regarded as not sensitising.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
No. of animals per dose:
10 animals in the treatment group of the main test
5 animals in the control group of the main test

5 animals in the concomitant control group

(in case of a questionable result additional animals will be tested to give a total of 20 treatment and 10 control animals)

6 animals for determination of the primary non-irritant concentration
3 animals for determination of tolerance of intradermal injections
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 intradermal injections and 1 epidermal application
- Exposure period: intradermal injections on day 1 and epidermal application on day 9 (occlusive, bandage removed after 48 h)
- Test groups: 3 sites (50 % Freund's Adjuvant in physiological saline only, test substance in semi-liquid paraffin and test substance in 50 % Freund's Adjuvant in physiological saline) per injection, test substance in petrolatum for dermal application
- Control and concomitant control group: 3 sites (50 % Freund's Adjuvant in physiological saline, semi-liquid paraffin and 50 % Freund's Adjuvant in physiological saline) per injection, petrolatum for epidermal application
- Site: dorsal area measuring 2 x 4 cm in the vicinity of the shoulders for intradermal injections, epidermal application covered the same area where the intradermal injections had been placed
- Frequency of applications and duration: see above
- Concentrations: see above

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 15 (concomitant control group) and day 22 (control and treatment group)
- Exposure period: occlusive for 24 h (removal of bandage on day 23)
- Test groups: test substance
- Control group: test substance
- Concomitant control group: test substance

- Site: left flank
- Concentrations: see above
- Evaluation (h after challenge = h after removal of the patch): 24 h and 48 h
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: animal no 15 was moribund on day 21 and therefore excluded from further treatment. All other animals did not show any signs of intoxication..
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Concomitant control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Concomitant control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Concomitant control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Concomitant control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
not sensitising
Endpoint:
skin sensitisation: in chemico
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Based on available data the substance is considered not to exert any sensitizing effects on the respiratory tract; when aerosolized in respirable form, the substance is considered likely to behave like an inert dust. Therefore, it is concluded that classification is not warranted.

Justification for classification or non-classification

The test item did not show skin sensitising properties when tested according to OECD TG 406 (GPMT) in compliance with GLP criteria. Therefore, Pigment Yellow 191 does not have to be classified as a skin sensitizer according to the criteria laid down in Directive 67/548/EEC and Regulation (EC) No 1272/2008.

 

It can reasonably be deduced that Pigment Yellow 191 does not cause respiratory tract sensitization and thus does not have to be classified according to the criteria laid down in Directive 67/548/EEC and Regulation (EC) No 1272/2008.