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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:
1999-05-28 to 1999-04-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, D-16352 Schönwalde.
- Weight at study initiation: 312 - 387 g
- Housing: polycarbonate (macrolone type IV, floor area 1800 cm2) cages
- Diet: pelleted diet "Altromin 3122" (supplier: Altromin, D-32791Lage, Lippe)
- Water: The guinea pigs had free access to vitamin C enriched domestic quality water acidified to pH 2.5 with Hydrochloric acid in order to prevent microbiological growth.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C ± 3 °C
- Humidity: 55 % ± 15 %
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 24 hour cycle of 12 hours light and 12 hours darkness

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
The undiluted test article was chosen for the dermal inductions. A 75 % test article concentration was chosen for the challenge application.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
The undiluted test article was chosen for the dermal inductions. A 75 % test article concentration was chosen for the challenge application.
No. of animals per dose:
30 females divided into a test group of 20 animals and a control group of 10 animals.
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- Frequency of applications: The procedure was repeated on days 7 and 14.
- Duration: 6 hours
- Site: left flank region
- Concentrations: undilluted test item
- control group: The guinea pigs in the control group were treated in the same manner, but with the vehicle only.
- Other: The animals in the test group were induced with the test article and the animals in the control group were induced with sesame oil

B. CHALLENGE EXPOSURE
- Exposure period: 6 hours
- Site: right flank region
- Concentrations: 75 % test article.
- Evaluation (hr after challenge): Four weeks after the first induction (day 28) all test and control group animals were challenged. Each challenge site was examined 24 and 48 hours after removal of the patch. About 3 hours before the 24-hour reading the sites were clipped and shaved in order to facilitate the evaluation.
Positive control substance(s):
yes
Remarks:
a-Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undilluted
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: negative control. Dose level: undilluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undilluted
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: negative control. Dose level: undilluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Health and body weight: None of the animals showed signs of ill health. The animals had a normal body weight gain during the study period.

After the challenge application all animals in the control group and in the test group were free of any signs of skin reactions.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information