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Endpoint summary

Description of key information

In order to assess the sensitizing potential a Magnisson & Kligman test according to OECD 406 was performed in 15 (10 test and 5 control) female Mol:DH (Moellegaard) guinea pigs. After the challenge procedure 0/10 test animals showed skin reactions. Based on this result the test item has not to be classified as skin sensitiser.

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

Study period:

July - Aug 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

Adopted July 17, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

Adopted July 30, 1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Version / remarks:

Aug. 1998

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The substance has been tested according to the OECD Guideline 406, Guinea pig Maximization Study before the LLNA test model was selected to be the preferred test system under the REACH Regulation.

Species:

guinea pig

Strain:

other: Mol:DH (Moellegaard)

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: M & B A/S, Ry, Denmark
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation:
276 g (mean)
- Housing: in transparent macrolon cages (type V) on soft wood granulate in an air-conditioned room, 5 animals per cage
- Diet (e.g. ad libitum): ssniff Ms-H (V 2233), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES:
From: 1. July To: 1 Aug. 2003

Route:

intradermal

Vehicle:

other: Tylose

Concentration / amount:

5%

Day(s)/duration:

n.a.

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Route:

epicutaneous, occlusive

Vehicle:

other: Tylose

Concentration / amount:

25%

Day(s)/duration:

2

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Tylose

Concentration / amount:

25%

Day(s)/duration:

1

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

Control: 5
Treatment: 10

Details on study design:

RANGE FINDING TESTS:
Determination of the non irritating (dermal) concentration:
3 animals; 25, 5 and 1% test substance in tylose
Determination of the tolerance of the intradermal injections:
2 animals; 5, 1 and 0.2% in tylose

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2

- Exposure period:
intradermal: n.a.
epicuteous:2 days

- Test groups: 1
- Control group: 2
negative (vehicle) and positive (alpha-hexylcinnamaldehyde) control

- Site: dorsal area
- Frequency of applications:
Day 1: intradermal induction
Day 8: dermal induction

- Concentrations:
intradermal: 5% in tylose
dermal: 25% in tylose


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 (Study day 22)
- Exposure period: 24 h
- Test groups:
10 animals; 25% substance in tylose
- Control group:
5 animals; 25% in tylose

- Site: left flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48h after removel of patches

Challenge controls:

Challenge / performed on test day 22
The test and control guinea pigs were challenged after the epidermal induction aplication and were treated in the same way.
One area of approx. 5x5 cm on the left flank was shaved mechanically. An amount of 0.5 mL of the test substance was administered to a 2x2 cm cellulose patch. The administration area was then kept for 24 h under an occlusive bandage covered with an impermeable film and an elastic badange.
On study day 23 the bandage was removed. Any remnants of the test substance were carefully washed of with warm water. The skin was examined approx. 24 and 48 h after removal of the patches.

Positive control substance(s):

yes

Remarks:

alpha-hexylcinnamaldehyde

Positive control results:

After the challenge treatment nine of ten animals (90%) showed a positive reaction during the observation period.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

25%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no clinical symptoms

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

15

Clinical observations:

no clinical symptoms

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

25%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no clinical symptoms

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

15

Clinical observations:

no clinical symptoms

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

25%

No. with + reactions:

8

Total no. in group:

10

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

25%

No. with + reactions:

9

Total no. in group:

10

Body weight gains and clinical signs

The body weight gains of the animlas were not impaired. The treated animlas showed no clinical signs of intoxication throughout the study.

Intradermal induction treatment

Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe edema. The administration sites treated with the test substance in tylose showed clear edema. Intradermal injection of the vehicle alone exhibited no signs of irritation. Due to the color of the test substance the treated skin of the animals colud not be assessed for erythema. Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at day 7.

Dermal induction treatment

After removal of the patches at day 10, clear edema, indurated and encrusted skin were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance alone showed slight edema. THe administration sites treated with the vehicle alone showed no signs of irritation. Due to the color of the test substance the treated skin of the animals could not be assessed for erythema.

Dermal challenge treatment

No skin reactions were observed in the control and the treatment group 24 and 48 h after removal of the occlusive bandage.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study the test substance is considered to be non-sensitising.

Executive summary:

Skin sensitisation of the test item was performed in female guinea pigs according to the method of Magnusson&Kligman.

Intradermal induction was performed using 5% test substance in tylose, dermal induction using 25% test item in tylose. The valdity of the test system is confirmed by the periodically conducted positive control test using alpha-hexylcinnamaldehyde for maximisation test.

Based on the results of this study the test item showed no evidence for sensitising properties.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The sensitization potential of HPP Additve D11 was investigated according to OECD Guideline 406. The test item concentrations chosen for the the guinea pig maximisation test were:

- intradermal induction: 5% in tylose

- epicutaneous induction: 25% in tylose

- challenge: 25% in tylose

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

HPP Additve D11 showed no skin sensitizing properties in the guinea pig maximisation test according to the OECD guideline 406.

With reference to the absence of skin reactions HPP Additive D11 has not to be classified as skin sensitiser according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).