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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
Study period:
12 Aug to 12 Sept 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

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
Qualifier:
according to guideline
Guideline:
other: JMAFF Japanese Test Guidelines
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): UY-330
- Physical state: solid
- Appearance: white powder
- Batch No.: CE-201
- Expiration date of the lot/batch: 01 Jan 2005
- Storage condition of test material: at room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: approximately 4 weeks
- Weight at study initiation: 310 - 364 g
- Housing: Maximal 5 animals were group housed in metal cages (57 cm x 41 cm x 23 cm height) with wire-mesh floors or in cages (74 cm x 54 cm x 25 cm height) with purified sawdust as bedding material.
- Diet: Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, ad libitum and pressed hay twice a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 - 22.7
- Humidity (%): 45 - 89
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: corn oil, Freund's Complete Adjuvant (FCA)
Concentration / amount:
Intradermal induction: 2%
Topical induction: 50%
Challenge: 50%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil, Freund's Complete Adjuvant (FCA)
Concentration / amount:
Intradermal induction: 2%
Topical induction: 50%
Challenge: 50%
No. of animals per dose:
5 irritation control animals, 10 animals in test group, 4 animals for the preliminary irritation study
Details on study design:
RANGE FINDING TESTS:
To find an appropriate concentration for intradermal induction, the maximum concentration that could technically be injected and three lower concentrations of the test substance in corn oil were injected into the scapular region of two guinea pigs. Each of these guinea pigs received 0.1 mL of two different concentrations (2 and 5% or 10 and 20%, respectively) in duplicate. At 24 and 48 h post injection, 10 and 20% of the test substance caused well defined erythema, whereas 2 and 5% of the test substance lead to slight erythema formation. However, the injection of 5, 10 and 20% of the test substance was difficult and the reliability of the injected volume could not be established. Because 2% of the test substance in corn oil was considered the highest concentration that could reproducibly be injected this concentration was used in the main study for the intradermal induction.
The two guinea pigs used for the testing of intradermal irritation and two additional animals were epicutaneously treated on one flank with 0.5 mL of 20 and 50% or 5 and 10% of the test substance, respectively, to provoke a slight irritative effect. No irritation was observed at any concentration level. Because a concentration of 50% test substance was the maximum concentration that could technically be applied, this concentration was used in the main study for epicutaneous induction and challenge. To provoke a mild inflammatory reaction, the scapular treatment site was rubbed with 10% sodium dodecyl sulfate (SDS) in vaseline, the day before the epicutaneous induction.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one epicutaneous treatment, respectively
- Exposure period: single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections)
Injection 1: 0.1 mL of a 1:1 mixture (w/w) of FCA (Difco, Detroit, USA) and water for injection (Fresenius AG, Bad Homburg, Germany)
Injection 2: 0.1 mL of 2% (w/w) test substance in corn oil
Injection 3: 0.1 mL of a 1:1 mixture (w/w) of 4% test substance in corn oil and FCA
Epicutaneous: 0.5 mL of 50% test substance in corn oil
The day before the epicutaneous induction, the scapular treatment site was rubbed with 10% SDS in vaseline, to provoke a mild inflammatory reaction.

- Control group:
Intradermal (3 pairs of injections)
Injection 1: 0.1 mL of a 1:1 mixture (w/w) of FCA (Difco, Detroit, USA) and water for injection (Fresenius AG, Bad Homburg, Germany)
Injection 2: 0.1 mL of corn oil
Injection 3: 0.1 mL of a 1:1 mixture (w/w) of corn oil and FCA
Epicutaneous: 0.5 mL of corn oil
The day before the epicutaneous induction, the scapular treatment site was rubbed with 10% SDS in vaseline, to provoke a mild inflammatory reaction.

- Site: scapular region (intradermal and epicutaneous)
- Frequency of applications: intradermal injection on Day 1 and epicutaneous application on Day 8
- Duration: single intradermal injections; epicutaneous treatment for 48 h
- Concentrations: intradermal 2%, epicutaneous 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24 h
- Test groups: 0.1 mL of the test substance in corn oil and 0.1 mL corn oil
- Control group: 0.1 mL of the test substance in corn oil and 0.1 mL corn oil
- Site: one flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
historical positive control: 20% alpha-Hexylcinnamicaldehyde (Tech., 85%) in water

Results and discussion

Positive control results:
The procedures used in this study were validated using the positive control substance alpha-Hexylcinnamicaldehyde. The most recent validation of the test system was performed between May and June 2003. The positive control substance induced positive reactions in 6/10 animals (60%) thus meeting the reliability criteria for the guinea pig maximization test (≥ 30%).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; Challenge: 50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Induction: 0%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 2% and 50%; Challenge: 50%
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: Induction: 2% and 50%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Induction: 20% and 100%; Challenge: 20%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Induction: 20% and 100%; Challenge: 20%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; Challenge: 50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction: 0%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 2% and 50%; Challenge: 50%
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: Induction: 2% and 50%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Induction: 20% and 100%; Challenge: 20%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Induction: 20% and 100%; Challenge: 20%. No with. + reactions: 5.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Results of the challenge phase

The challenge treatment with 50% of the test substance or the vehicle did neither in the test substance group nor in the negative control group result in any erythema or edema at the 24 and 48 h reading time points.

Results of the induction phase

The intradermal injections of 0.1 mL of FCA (50% (w/w)) caused well-defined to moderate erythema in the test and control group. The test substance (2% (w/w)) and a 1:1 mixture of the test substance with FCA caused slight to moderate erythema in the test group. In the control group, the intradermal injection of 0.1 mL of the vehicle or a 1:1 mixture of the vehicle and FCA leads to slight to well-defined erythema.

After the epicutaneous treatment of the test group with 50% of the test substance, no erythema or edema formation was observed in any animal.

Clinical observations

No mortality occurred and no symptoms of systemic toxicity were observed during the study period. There was no difference in body weight and body weight gain between the test group and the negative control.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified