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Diss Factsheets

Administrative data

Description of key information

Testing for sensitising properties of the test item was performed in female guinea pigs according to the adjuvant sensitisation test by Magnusson and Kligman (Guinea pig Maximisation Test). Intradermal induction was performed using 15% test item in PEG 300 or in a mixture of Freund's Adjuvant and physiological saline (1:1 (v/v)). Dermal induction was carried out with 50 % test item in PEG 300. Using 5% test item in PEG 300 for the first challenge treatment resulted in a 100 % incidence of animals with skin reactions (with either erythema scores of 1 or 2) at the 48 hour reading in both the test group as well as the control group. Therefore a second challenge was conducted using either 3 % or 1 % test item in PEG 300. This second challenge included also a second control group consisting of 5 naive animals. At the 24 hour reading 1 out of 5 control group I animals showed skin reactions (20%), while 4 out of 10 test group animals and 2 out of 5 control group II animals showed positive results (i.e. 40% in each group). Skin reactions were less severe than in the first challenge (only erythema score 1). At the 48 hour reading all effects in the control groups were vanished and persisted only in 2 out of 10 test animals (20%). The positive control from the test lab showed distinctive positive results under the conditions applied in the lab (up to 100% of animals with positive skin reactions weras the control animals showed no skin reactions). Taken the results together (comparable effects in control as well as test animals; valid positive control) and knowing the fact that the GPMT tends to overestimate the sensitising potency of test items the overall conclusion is that the test item is not sensitising.

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
Study period:
From 1 MAR 2006 to 21 APR 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EU method B.6; OECD TG 406)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The data from a non-LLNA method were already available before the LLNA method was introduced.
Specific details on test material used for the study:
Pigment Orange 36
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 5 to 6 weeks
- Housing: Individually in macrolon cages (type 4)
- Diet: Pelleted standard Provimi Kliba 3418 guinea pig breeding/ maintenance diet (batch no. 85/05; provided by Provimi Kliba AG, CH-4303 Kaiseraugst); ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Thirteen days under laboratory conditions after health examination for the control group I and test group. No acclimatization for the animals of the pretests and control group II

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
15 % for the intradermal induction
50 % for the epidermal induction
5 % in PEG 300 for the first challenge
3 % and 1 % in PEG 300 for the second challenge
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
15 % for the intradermal induction
50 % for the epidermal induction
5 % in PEG 300 for the first challenge
3 % and 1 % in PEG 300 for the second challenge
No. of animals per dose:
5 control I animals
10 test animals
5 control II animals
Details on study design:
A. INDUCTION EXPOSURE
Intradermal induction:
An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair.
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 intradermal, 1 epidermal)
- Exposure period: 48 hours for the epidermal induction (occlusive dressing)
- Test groups:
Three pairs of intradermal injections (0.1 mL/site) were made at the border of a 4 x 6 cm area in the clipped region as follows:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test item at 15 % in PEG 300.
3) The test item at 15 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.test item in FCA
- Control group:
Three pairs of intradermal injections (0.1 mL/site) were made at the border of a 4 x 6 cm area in the clipped region as follows:
Control Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) PEG 300
3) 1:1 (w/w) mixture of PEG 300 in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Frequency of applications: twice in 8 days
- Duration: 1-8 d
- Concentrations: see above ( The amount of test item preparation applied for the second administration was approximately 0.3 g.
The guinea pigs of the control group were treated as described above with PEG 300 only, applied at a volume of approximately 0.3 mL.)
- Evaluation: The reaction sites were assessed approximately 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
(i.e.: 0 = no visible change
1 = discrete or patchy erythema
2 = moderate and confluent erythema
3 = intense erythema and swelling)

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 22 & 36
- Exposure period: 24 hours for the first and second challenge exposure (occlusive dressing)
- Test groups: test item in PEG 300
- Control group: test item in PEG 300
- Concentrations: 3 different (see abovoe)
- Site: right side
- Evaluation (hr after challenge): 24, 48 (approximately 48 and 72 hours from the start of the challenge application respectively)
Challenge controls:
During the second challenge, which was performed in the same way as the previous challenge, five naïve control animals (control group II) were included into the test.
Positive control substance(s):
yes
Remarks:
ALPHA-HEXYLCINNAMALDEHYDE
Positive control results:
The test with the positive control substance was performed from 2005-11-25 to 2006-01-13
Summary of results:
- first challenge with ALPHA-HEXYLCINNAMALDEHYDE at 0.1 % (w/w) in PEG 300: 1/10 test animals showed discrete/patchy erythema at the 24- and 48-hour reading after the treatment. No skin effect was observed in the control group.
- second challenge treatment with ALPHA¬HEXYLCINNAMALDEHYDE at 3 % (w/w) in PEG 300.: 10/10 animals showed discrete/patchy to moderate/confluent erythema with/without scales or oedema at the 24- and 48-hour reading. Discrete/patchy erythema was observed in 1/5 control animals at the 24-hour reading when treated under the same conditions.
- second challenge treatment with ALPHA¬HEXYLCINNAMALDEHYDE at 1 % (w/w) in PEG 300: 7/10 test animals showed discrete/patchy to moderate/confluent erythema at the 24-hour reading and in 6/10 test animals discrete/patchy erythema with/without scales at the 48-hour reading were noted. No skin effect was observed in the control group.
- No toxic signs were evident in the guinea pigs of the control or test group.
- No deaths occurred.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
PEG 300 only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group I
Dose level:
PEG 300 only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group I. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
PEG 300 only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group I
Dose level:
PEG 300 only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group I. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: control group II
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: control group II. Dose level: 1% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: control group I
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: control group I. Dose level: 1% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: control group I
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: control group I. Dose level: 1% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: control group II
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: control group II. Dose level: 1% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: control group I
Dose level:
3% in PEG 300
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: control group I. Dose level: 3% in PEG 300. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: conrol group II
Dose level:
3% in PEG 300
No. with + reactions:
2
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: conrol group II. Dose level: 3% in PEG 300. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3% in PEG 300
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3% in PEG 300. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3% in PEG 300
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3% in PEG 300. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: control group I
Dose level:
3% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: control group I. Dose level: 3% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: control group II
Dose level:
3% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: control group II. Dose level: 3% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% in PEG 300
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in PEG 300. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% in PEG 300
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in PEG 300. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group I
Dose level:
5 % in PEG 300
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group I. Dose level: 5 % in PEG 300. No with. + reactions: 4.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group I
Dose level:
5% in PEG 300
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
no signs of clinical toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group I. Dose level: 5% in PEG 300. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: no signs of clinical toxicity.
Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) no 1272/2008
Conclusions:
Based on the above mentioned findings (i.e. comparable effects seen in control and test group) the test item is not considered to be sensitising to skin.
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 (Guinea pig Maximisation Test). Intradermal induction was performed using 15% test item in PEG 300 or in a mixture of Freund's Adjuvant and physiological saline (1:1 (v/v)). Dermal induction was carried out with 50 % test item in PEG 300. Using 5% test item in PEG 300 for the first challenge treatment resulted in a 100 % incidence of animals with skin reactions (with either erythema scores of 1 or 2) at the 48 hour reading in both the test group as well as the control group. Therefore a second challenge was conducted using either 3 % or 1 % test item in PEG 300. This second challenge included also a second control group consisting of 5 naive animals. At the 24 hour reading 1 out of 5 control group I animals showed skin reactions (20%), while 4 out of 10 test group animals and 2 out of 5 control group II animals showed positive results (i.e. 40% in each group). Skin reactions were less severe than in the first challenge (only erythema score 1). At the 48 hour reading all effects in the control groups were vanished and persisted only in 2 out of 10 test animals (20%). The positive control from the test lab showed distinctive positive results under the conditions applied in the lab (up to 100% of animals with positive skin reactions weras the control animals showed no skin reactions). Taken the results together (comparable effects in control as well as test animals; valid positive control) and knowing the fact that the GPMT tends to overestimate the sensitising potency of test items the overall conclusion is that the test item is 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
other:
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
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see Rationale and Justification for the Analogue Read-Across Approach – Nanoforms and Bulk Forms (Chapter 13)
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
PEG 300 only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: control 1
Dose level:
Vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Vehicle only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control 1
Dose level:
Vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: control 2
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: Control 1
Dose level:
1% in PEG 300
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Control 1
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Control 2
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: Control 1
Dose level:
3%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: Control 2
Dose level:
3%
No. with + reactions:
2
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Control 1
Dose level:
3%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Control 2
Dose level:
3%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
no clinical signs
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no clinical signs
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Cntrol 1
Dose level:
5%
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
no clinical signs
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control 1
Dose level:
5%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
no clinical signs
Interpretation of results:
GHS criteria not met
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

No classification as no adverse effects observed.