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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 09 - December 08, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted. An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): BMH
- Physical state/Description: white crystal
- Storage condition of test material: In the refrigerator 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: approx. 6 weeks old
- Weight at study initiation: 396 - 500 g
- Housing: Group housing of 5 animals per labelled metal cage with wire-mesh floors.
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg); (Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, Lage, Germany). Hay (B.M.I., Helmond, The Netherlands) was provided twice a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions.

Certificates of analysis of the diet and certificates of quarterly analysis for tap-water were examined and retained in the NOTOX archives.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: October 09, 2000 To: December 08, 2000

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction: Intradermal: 1% in corn oil.
Epidermal: 50% in corn oil.

Concentration of test material and vehicle used for each challenge: 50% in corn oil.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction: Intradermal: 1% in corn oil.
Epidermal: 50% in corn oil.

Concentration of test material and vehicle used for each challenge: 50% in corn oil.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS:
Practical feasibility of administration determined the highest starting-concentration for each route. The starting- and subsequent concentrations were taken from the series: 100% (undiluted), 50%, 20%, 10%, 5%, 2%, 1% and if needed, further lower concentrations using the same steps.
The test system and procedures were identical to those used during the main study, unless otherwise specified. The four animals selected were between 4 and 9 weeks old. No body weights were determined at termination.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one intradermal (day 1) and one topical (day 8, 48h).
- Exposure period: 48 topical induction. SDS was applied to the application site before application.

B. CHALLENGE EXPOSURE
- No. of exposures: 1 topical
- Day(s) of challenge: 2 weeks after last induction
- Exposure period: 24 hours
- Site: One flank
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing

Positive control substance(s):
yes
Remarks:
at regular intervals ALPHA-HEXYLCINNAMIC ALDEHYDE, TECH. 85%

Results and discussion

Positive control results:
The reliability check with ALPHA-HEXYLCINNAMICALDEHYDE, TECH. 85% indicates that the Maximization test as performed at NOTOX is an appropriate model for testing for contact hypersensitivity. See the document 'Reliability check' in the attached background material.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Skin reactions varying between grades 1 and 3 were observed in nine experimental animals in response to the 50% test substance concentration
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Skin reactions varying between grades 1 and 3 were observed in nine experimental animals in response to the 50% test substance concentration.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Skin reactions varying between grades 1 and 3 were observed in nine experimental animals in response to the 50% test substance concentration. Schar formation was noted.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Skin reactions varying between grades 1 and 3 were observed in nine experimental animals in response to the 50% test substance concentration. Schar formation was noted..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were evident in the control animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were evident in the control animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
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: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were evident in the control animals
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were evident in the control animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
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: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Group:
positive control
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Refer to Reliability check' in the attached background material for detailed results

Any other information on results incl. tables

Tables of the main study have been included in the document "Sensitization tables" in the attached background material.

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
Intradermal: Slight to well-defined erythema

Epidermal: none.

Evidence of sensitisation of each challenge concentration:
9/10

Other observations:
Eschar formation was seen in the majority of the treated skin sites among the experimental animals.

No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

Body weights and body weight gain of experimental animals remained in the same range as controls over the study period

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guinea pig maximization test performed according to OECD 406 and GLP, BMH showed skin sensitising properties in guinea pigs. BMH should be labelled as: May cause an allergic skin reaction (H317).