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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: Guideline study conducted in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Remarks:
BASF AG, Department of Toxicology
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritoltetracyanoacetic ester
EC Number:
605-830-2
Cas Number:
178671-69-7
Molecular formula:
C17 H16 N4 O8
IUPAC Name:
Pentaerythritoltetracyanoacetic ester

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White, Dunkin Hartley Crl:(HA)BR [SPF]
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH - Wiga, Kisslegg, FRG
- Age at study initiation: Young adult animais
- Weight at study initiation: 334 - 367 g
- Housing: Stainless steel wire mesh cages with plastic-coated grating, floor area 40 cm x 51 cm. 5 animals per cage.
- Diet: Kliba Labordiät (Kaninchen-Meerschweinchen-Haltungsdiät) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1% Tylose CB 30.000 in aqua. bidest.
Concentration / amount:
1st application: Induction 5 % intradermal
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1% Tylose CB 30.000 in aqua. bidest.
Concentration / amount:
1st application: Induction 5 % intradermal
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
No. of animals per dose:
test group: 10
control group: 5
Details on study design:
RANGE FINDING TESTS:
The concentrations for the test substance suitable for use in the main experiment were determined in a pre-test. A concentration of the test substance that is welI-tolerated locally and systemically should be chosen for the intradermal induction treatment in the main test. In the pre-test, a 5 % concentration of the test substance caused moderate and confluent erythema and swelling in all test group animals and was selected for the main test. For the dermal induction treatment the highest concentration of the test substance that causes slight to moderate irritation and for the challenge the maximum non-irritant concentration was determined with the pretest. A test substance concentration of 50 % was selected for the epicutaneous induction and a test article concentration of 10 % was chosen for the challenge reaction.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
First induction
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shoulder of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test article in the vehicle
- test article in the adjuvant saline mixture
Second induction
-epicutaneous: test substance in vaseline
- Control groups:
-treated analogue to the test group but without test substance
A second control group (control group 2) has been intended for a potential second challenge in case of borderline results at the first challenge.
- Site: shoulder.
- Frequency of applications: day 1 intradermal injections and 1 week later epicutanous induction
- Concentrations: intradermal 5%; epicutaneous 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day of challenge: 14 days after the percutaneous induction.
- Exposure period: 24 hours
- Test groups: The test group and control group 1 were treated with the test substance formulation. Additionally, 1% Tylose OB 30.000 in aqua bidest. was applied as a vehicle control. Gontrol group 2 only received 1 % Tylose OB 30.000 in aqua bidest.
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch

OTHER:
A positive control (reliability check) with a known sensitizer was not performed during that study. However, a separate study is performed twice a year in the Iaboratory. The latest positive control experiment (included in the study report) with Alpha-Hexylcinnamaldehyde techn. 85% showed that the test system was able to detect sensitizing compounds under the Iaboratory conditions chosen.
Challenge controls:
Control animals were exposed to the vehicle and 10% test substance in the vehicle at the epicutaneous challenge.

Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control was used in this test. Sensitivity of the strain is checked every 6 months with Alpha-Hexylcinnamaldehyde techn. 85%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group 1
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 1. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: 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: control group 2. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
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 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group 1
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group 1. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: 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: 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:
test chemical
Dose level:
10 %
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 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the experimental conditions employed, 0% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. It was concluded that the test substance does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test.
Executive summary:

The test substance was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman. The intradermal induction with 5% test substance preparations caused moderate and confluent erythema and swelling in all test group animals. After the percutaneous induction with a 50% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to moderate and confluent erythema and swelling in all test group animals. A challenge with 10 % of the test substance was performed 14 days after the percutaneous induction. None of the animals of the test groups and no animal of the control groups showed skin findings after the challenge. The sensitivity of the used animal strain was tested before with a positive control substance (not performed in this study). Based on the results of this study it was concluded that the test article does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.