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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
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to guideline. Full report available. However, no information of preliminary investigation (dose finding).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Maximizationtest according to Magnusson-Kligman (J Invest Dermatol 52: 268-276, 1969)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
existing study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cumol
- Substance type: clear waterlike liquid
- Physical state: liquid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): Not given
- Storage condition of test material: Dark, in refrigerator

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Age at study initiation: Not reported
- Weight at study initiation: Exposuregroup: mean weight 293.8 g, Control group: 291.6 g
- Housing:1-5 animals in Makrolon Typ IV cages
- Diet (e.g. ad libitum): G4 diet for guinea pigs, Ssniff Spezialfutter GmbH, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-1 °C
- Humidity (%): 60+-5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
maize oil
Concentration / amount:
Intradermal induction: 10%
Epicutaneous induction: 75%
Epicutaneous challenge: 40%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Intradermal induction: 10%
Epicutaneous induction: 75%
Epicutaneous challenge: 40%
No. of animals per dose:
20 per dose, 10 per control
Details on study design:
RANGE FINDING TESTS: None

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injection
6 intradermal injections were made symetrically and simultaneously on a 4 x 6 cm shaved areal on each shoulder:
0.1 cm³ of a mixture of Freunds Adjuvant (FCA) and H2O (VE-Water), 1:1
0.1 cm³ of a 10% test solution in maize oil
0.1 cm³ of a 10% test solution in a mixture on FCA and H2O, 1:1

Topical application
One week after intradermal injection a 2 x 4 cm patch fully loaded with 75% test solution in maize oil was applied to each area and fixed for 48h.

B. CHALLENGE EXPOSURE
Topical application
Two weeks after topical induction the left flank was shaved and a 2 X 2 cm patch fully loaded with 40% test solution in maize oil was applied. The pathc was fixed for 24 h.

24h and 48h after removing of the patch the skin reaction was observed and recorded according to the Magnusson & Kligman grading scale.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slight inflammation at all FCA treated injection sites (also in control group). Incrustation of injection sites after 24 h at all animals.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight inflammation at all FCA treated injection sites (also in control group). Incrustation of injection sites after 24 h at all animals..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Cumene was not sensitizing to guinea pigs in a test performed according to OECD 406.
Executive summary:

No skin sensitisation were noted among a group of 20 female guinea pigs treated with cumene in a Magnusson-Kligman maximisation test conducted according to OECD 406. For induction 0.1 cm³ of a 10% test solution was tested and for challenge the concentration was 40%.