Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch No.: Part 704, tank 328

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Designation: Pirbright White, Dunkin, Hartley HOE DHPK (SPF-LAC) guinea pig
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, OW-4923 Extertal 1, Germany
- Housing: Makrolon, type IV, 5 animals per cage
- Body weight at the beginning of the study: 278-328 g
- Diet: Kliba 341, 4 mm (rabbit-guinea pig-feed) ad libitum
- Water: ad libitum; tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light):12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
Intradermal induction: 0.1 ml solution with 5% test substance
Percutaneous induction: 0.3 g formulation with 25% test substance
Challenge: 0.15 g formulation with 10% test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Intradermal induction: 0.1 ml solution with 5% test substance
Percutaneous induction: 0.3 g formulation with 25% test substance
Challenge: 0.15 g formulation with 10% test substance
No. of animals per dose:
10 (Test group)/ 5 (Control groups)
Details on study design:
RANGE FINDING TEST:
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance formulation.
Exposure period:
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitisation reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application :
- Flank, respective on the same area
Number of test animals :
- 4 per test concentration
Readings :
- About 24 and 48 h after the beginning of application

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: 2
- Test groups: 1: A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0 .9% aqueous NaCl-solution in a ratio of 1:1 B) middle row : 2 injections each of 0.1 ml of the test substance formulation (5% in olive oil) C) back row: 2 injections each of 0.1 ml 5% test substance in A)
- Control group: 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site: Shoulder
- Frequency of applications: once
- Duration: 7 days (reading after 24 h)

Percutan:
- No. of exposures: 1
- Test group: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. In the case of liquids the filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance in olive oil (25%).
- Control groups: Both control groups were treated analogously to the test group but only with the solvent without the test substance
- Site: Shoulder
- Frequency of applications: once
- Duration: 48 h

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: 21 (after intradermal induction)
- Exposure period: 24 h
- Test group: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance in olive oil (10%).
Challenge :
- Treatment of the test group with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle.
- Control group: 2: control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle. Control group 2 only received olive oil DAB 9 .
- Site: flank
- Evaluation (h after challenge): 24 and 48 h after removal of the patch

Challenge controls:
yes, (control group 2)
Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitro-benzol

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% in olive oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% in olive oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
edema and erythema of varying degree
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: edema and erythema of varying degree.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Negative control group 1
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Negative control group 1
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Negative control group 2
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Negative control group 2
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion