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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:
key study
Reliability:
1 (reliable without restriction)

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:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Qualifier:
according to
Guideline:
other: JMAFF, Japanese Test Guidelines
Qualifier:
according to
Guideline:
other: method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig"
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Adequate existing data that allow a conclusion on the sensitizing potential of the substance were available

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
preliminary irritation study (intradermal): 50%, 20%, 10%, 5%, 2%, 1%, 0.5% and 0.2%
preliminary irritaion study (epidermal): 50%, 20%, 10%, 5%, 2%
main irritation study (induction): 0.5% (intradermal) and 5% (epidermal)
main irritation study (challenge): 1% and 5%
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
preliminary irritation study (intradermal): 50%, 20%, 10%, 5%, 2%, 1%, 0.5% and 0.2%
preliminary irritaion study (epidermal): 50%, 20%, 10%, 5%, 2%
main irritation study (induction): 0.5% (intradermal) and 5% (epidermal)
main irritation study (challenge): 1% and 5%
No. of animals per dose:
10
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamic aldehyde, tech.85%

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: induction readings
Group:
negative control
Dose level:
0.5% and 5%
Total no. in group:
5
Clinical observations:
max. erythema grade: 3; max. signs of necrosis: 8 mm in diameter. The skin reactions were considered to be signs of non-specific irritation.
Remarks on result:
other: see Remark
Remarks:
Reading: other: induction readings. Group: negative control. Dose level: 0.5% and 5%. Total no. in groups: 5.0. Clinical observations: max. erythema grade: 3; max. signs of necrosis: 8 mm in diameter. The skin reactions were considered to be signs of non-specific irritation..
Reading:
other: induction readings
Group:
test group
Dose level:
0.5% and 5%
Total no. in group:
10
Clinical observations:
max. erythema grade: 3, max. signs of necrosis: 8 mm in diameter
Remarks on result:
other: Reading:
Reading:
other: challenge readings
Group:
negative control
Dose level:
1% and 5%
Total no. in group:
5
Clinical observations:
grade 1 scaliness (at dose level 5%); no response (at dose level 1%). The skin reactions were considered to be signs of non-specific irritation.
Remarks on result:
other: see Remark
Remarks:
Reading: other: challenge readings. Group: negative control. Dose level: 1% and 5%. Total no. in groups: 5.0. Clinical observations: grade 1 scaliness (at dose level 5%); no response (at dose level 1%). The skin reactions were considered to be signs of non-specific irritation..
Reading:
other: challenge readings
Group:
test group
Dose level:
1% and 5%
Total no. in group:
10
Clinical observations:
grades up to 3, scabs and scaliness (both at 1% and 5%)
Remarks on result:
other: Reading:

Any other information on results incl. tables

Yellow staining was observed at the test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.

No mortality occurred and non 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:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
v171629 should be labelled as R43.