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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
From Jun. 04, 2002 to Sep. 19, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to EU Method B.5. OECD Guideline 405 and OPPTS 870.2400 in compliance with GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M&B A/S P.O.box 1079 DK-8680 Ry, Denmark
- Weight at study initiation: 377±22 g
- Housing: Transparent macrolon cages (type 5) on soft wood granulate in groups of 5 animals
- Diet: ssniff R/M-H, ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C

IN-LIFE DATES: From: Jun. 04, 2002 To: Jul. 05, 2002

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
- Determination of the primary non-irritant concentration: 1, 5 and 25 %
- Determination of the tolerance of the intradermal injections: 0.2, 1 and 5 %
- Challenge treatment· control and treatment group: 25 %

Challengeopen allclose all
Route:
other: dermal
Vehicle:
other: sesame oil
Concentration / amount:
- Determination of the primary non-irritant concentration: 1, 5 and 25 %
- Determination of the tolerance of the intradermal injections: 0.2, 1 and 5 %
- Challenge treatment· control and treatment group: 25 %

No. of animals per dose:
- Determination of the primary non-irritant concentration: 3
- Determination of the tolerance of the intradermal injections: 2
- Control group: 5
- Treatment group: 10

Details on study design:
RANGE FINDING TESTS:
Determination of the primary non-irritant concentration:
The following test concentrations were administered to the flanks of 3 guinea pigs:
1. 25.0 % in sesame oil (left flank); 5.0 % in sesame oil (right flank)
2. 25.0 % in sesame oil (left flank); 1.0 % in sesame oil (right flank)
3. 05.0 % in sesame oil (left flank); 1.0 % in sesame oil (right flank)

0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 h with a bandage and film. 24 h after removal of the patches, the treated skin areas were examined for erythema and edema.

Determination of the tolerance of the intradermal injections:
The following preparations were administered twice by intradermal injection to 2 guinea pigs:
Site 1. 2X0.1 mL 5.0 % in sesame oil
Site 2. 2X0.1 mL 1.0 % in sesame oil
Site 3. 2X0.1 mL 0.2 % in sesame oil

24, 48, 72 and 96 h after administration the injection sites were examined for local tolerance.

MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 2
- Exposure period: 1-7 d
- Test groups: Yes
- Control group: Yes, (50 % Freund's Adjuvant)
- Site: Dorsal area
- Frequency of applications: 2 in 7 d
- Duration: 7 d
- Concentrations: 5.0 % test substance in sesame oil

INDUCTION EXPOSURE (Dermal)
- No. of exposures: 0.5 mL of the test substance preparation as cellulose patch
- Test groups: Yes, 25.0 % test substance in sesame oil
- Control group: Yes, sesame oil
- Site: Dorsal area
- Frequency of applications: Single on Day 8
- Concentrations: 25.0 % test substance in sesame oil

B. CHALLENGE EXPOSURE (Dermal)
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Test groups: An amount of 0.5 mL 25.0 % test substance in sesame oil
- Control group:
- Site: Left flank
- Concentrations: 25 % test substance in sesame oil
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches

OTHER:

The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have

Challenge controls:
Not reported
Positive control substance(s):
yes
Remarks:
(Alpha-hexyl cinnamic aldehyde)

Study design: in vivo (LLNA)

Vehicle:
other: Not applicable
Concentration:
Not applicable

No. of animals per dose:
Not applicable

Details on study design:
Not applicable

Positive control substance(s):
other: Not applicable
Statistics:
No data

Results and discussion

Positive control results:
Alpha-hexyl cinnamic aldehyde was skin sensitiser and proved to be suitable for the determination of dermal sensitizers

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 % test substance in sesame oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % test substance in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % test substance in sesame oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % test substance in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25 % Alpha-hexyl cinnamic aldehyde in polyethylene glycol 400 (Day 22)
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
9 animals (90 %) showed a positive reaction during the observation period.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 25 % Alpha-hexyl cinnamic aldehyde in polyethylene glycol 400 (Day 22) . No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: 9 animals (90 %) showed a positive reaction during the observation period. .

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Any other information on results incl. tables

Results:

Determination of the tolerance of the intradermal injections

Intradermal injections with the 5.0, 1.0 and 0.2 % preparation caused slight erythema and edema. Based on this preliminary test, a 5 % preparation was selected for the intradermal injections in the main test.

 

Determination of the primary non-irritant concentration

No signs of irritation occurred after administration of the different test concentrations. Based on these results, a concentration of 25 % test substance in sesame oil was chosen for the challenge at Day 22.

 

Main test for the sensitizing properties

Body weight gains and clinical signs: 

The body weight gains of the animals were not impaired. The treated animals 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 erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in sesame oil showed slight erythema and edema. Intradermal injections of the vehicle alone exhibited no signs of irritation. Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at Day 7.

 

Dermal induction treatment

After the removal of the patches at Day 10, severe erythema and edema, indurated and encrusted skin were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance showed slight erythema and edema. The administration site treated with the vehicle alone showed no signs of irritation.

 

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.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
Executive summary:

A study was conducted to assess the sensitizing potential of the test substance in female guinea pigs (Magnusson & Kligman method) according EU Method B.6., OECD guideline 406 and OPPTS 870.2400 in compliance with GLP.

 

Intradermal induction was performed using 5 % test substance in sesame oil. Dermal induction and challenge treatment were carried out with 25 % test substance in deionised water.

The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the Buehler test.

 

Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.