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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:
weight of evidence
Study period:
29.06.1993 to 19.08.1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with an appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
The non-LLNA study was already available and a new test was not conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH.
- Age at study initiation: 'healthy young adults'
- Weight at study initiation: 500 g
- Housing: Maximum of five per Makrolon type IV cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29.06.1993 To: 19.08.1993

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: MEH 56 corn oil
Concentration / amount:
100% in induction exposures
25% in challenge exposure
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: MEH 56 corn oil
Concentration / amount:
100% in induction exposures
25% in challenge exposure
No. of animals per dose:
20 animals/test group
10 animals/control group
Details on study design:
1st application: Induction 100 % occlusive epicutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Induction 100 % occlusive epicutaneous

In the definitive test, a test group of 20 animals was induced with 100% test substance on days 0, 7 and 14 and subsequently challenged with 25% test substance in corn oil on day 28; 25% test article in MEH 56 corn oil was the maximum non-irritating concentration. A control group of 10 animals was induced and challenged with MEH 56 corn oil.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Overall result
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
test article-treated animals
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
test article treated animals
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
vehicle test group
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
vehicle test group
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Dose level:
positive control
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: Not specified.

Any other information on results incl. tables

There were no substance related effects or influence on body weight in either test or control animals. Slight erythema
and edema were observed during Induction Phases I, II and III in the test article-treated animals; no skin irritation
was observed in the control animals.  Positive skin reactions were observed in 13/20 test article-treated
animals (30 h or 54 h post administration); animals treated with vehicle alone showed no skin reaction (0/10).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Dynasylan VTMO was determined by the report author to be a sensitiser under the conditions of this test.