complex reaction mass of Chinese gum rosin post reacted with acrylic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 July 1998 and 29 August 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): ARAKAWA KE-604
- Physical state: pale yellow blocks
- Analytical purity: no data
- Lot/batch No.: R61132
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: David Hall Ltd, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 313-426 g
- Housing: singly or in pairs in polypropylene cages with woodflakes bedding
- Diet (e.g. ad libitum): Guinea Pig FD1 Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water (e.g. ad libitum): mains tap water
- Acclimation period:at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 49 - 62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

arachis oil

Induction 2

Concentration / amount:

Intradermal induction: 1 % w/v in arachis oil BP, 1% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
Topical induction: 50 % w/w in arachis oil BP
Topical challenge: 50 % and 25 % w/w in arachis oil BP

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Challenge 2

Concentration / amount:

Intradermal induction: 1 % w/v in arachis oil BP, 1% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
Topical induction: 50 % w/w in arachis oil BP
Topical challenge: 50 % and 25 % w/w in arachis oil BP

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS:
Sighting tests were performed for the selection of concentrations for intradermal induction, epicutaneous induction and epicutaneous challenge using a total of 6 guinea pigs. These animals did not form part of the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single intradermal injection on Day 0 and single topical application on the same skin area of the shoulder region on Day 7 for 48 h under occlusive dressing
- Test groups: 10 animals
- Control group: 5 animals
- Site: shoulder region
- Concentrations: Intradermal induction: 1 % w/v in arachis oil BP; topical induction: 50 % w/w in arachis oil BP.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours under occlusive dressing
- Test groups: 10 animals
- Control group: 5 animals
- Site: right flank region
- Concentrations: Topical challenge: 50 % and 25 % w/w in arachis oil BP
- Evaluation (hr after challenge): 24 and 48 hours after challenge dressing removal.

Challenge controls:

5 animals topically challenged with 50 % and 25 % w/w test substance in arachis oil BP

Positive control substance(s):

yes

Remarks:

2-Mercaptobenzothiazole, 2,4 Dinitrochlorobenzene

Results and discussion

Positive control results:

Historical positive control (performed approximately every six month) resulted in sensitisation incidences of 70 - 100 % (between 7 and 10 out of 10 animals).

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 and 50 % w/w

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no other reactions noted

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no other reactions noted.

Results 2

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

25 and 50 % w/w

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no other reactions noted

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no other reactions noted.

Results 3

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

25 and 50 % w/w

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no other reactions noted

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no other reactions noted.

Results 4

Reading:

2nd reading

Hours after challenge:

72

Group:

negative control

Dose level:

25 and 50 % w/w

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no other reactions noted

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no other reactions noted.

Any other information on results incl. tables

Table 1: Skin reactions observed after topical challenge with 25 and 50 % ARAKAWA KE-604 in arachis oil BP in guinea pigs

Animal group	Challenge concentration of test material	Observation time [h]	Number of animals with skin responses (Scale 0-3)				Sensitisation Incidence
			0	1	2	3
Test	25 % (w/w)	24	10	0	0	0	0/10
		48	10	0	0	0
Control		24	5	0	0	0
		48	5	0	0	0
Test	50 % (w/w)	24	10	0	0	0	0/10
		48	10	0	0	0
Control		24	5	0	0	0
		48	5	0	0	0

Summary: 

In a dermal sensitisation study 20 guinea pigs were tested according to the method of Magnusson and Kligman (OECD Guideline 406).Skin reactions were assessed 24 and 48 hours after topical challenge with 25 and 50 % of the test substanceARAKAWA KE-604in arachis oil.

No oedema or erythema formation was noted at any observation interval in all tested animals.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information No classification is required according to EU classification criteria.