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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
12 Nov 1984 - 18 Apr 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions. Lack of test material details, no reliability check.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of test materials details, no reliability check.
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of test materials details, no reliability check.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Guideline no published at time study conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
-Chemical denomination: Glyceride, C16-18 and C18 Mono- and Dihydroxy
- Physical state: white pellets of tallow-like consistence
- Analytical purity: no data
- Batch No.: 4026-3
- Melting point: approximately 94 °C

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 312 g (test group), 303 g (control group)
- Housing: 5 animals per cage in Makrolon Type IV
- Diet: Altromin Diet 3032 DK (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
Concentration / amount:
Induction:
Intradermal: 1 %
Epicutaneous: 50%

Challenge: 25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
Concentration / amount:
Induction:
Intradermal: 1 %
Epicutaneous: 50%

Challenge: 25%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
3 preliminary tests were performed with 5 animals each:
Intradermal application with a concentration of 1% of test substance in vaseline induced skin irritation (definite effects, without induction of necrosis). After epidermal application with a concentration of 50% of the test substance in vaseline, this concentration was determined as the minimal irritating concentration. To be able to determine the maximum non-irritating concentration for challenge treatment, intracutaneous injections of 0.1 mL FCA bilaterally of the vertebral column were made. 2 weeks later 25% and 50% test substance concentrations were applied for 24 h under plaster-covering. A concentration of 25% was found to be the maximum non-irritating concentration.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: FCA
Injection 2: test substance in paraffin
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in vaseline

- Control group:
Injection 1: FCA
Injection 2: paraffin
Injection 3: parafin in a 1:1 mixture (w/v) FCA
Epicutaneous: vaseline

- Site: shoulder region (intradermal + epicutanous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 1%, epicutaneous 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: cranial (vehicle) and caudal (test substance)
- Concentrations: 25%
- Evaluation (hr after challenge): 48 and 72

Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 1%; challenge: 25%
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: induction: 1%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 1%; challenge: 25%
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: induction: 1%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

No effects on bodyweight were observed during the study period. After intradermal injection all animals showed the expected reactions for FCA. Intradermal injections of the vehicle paraffin caused reactions as well (no further information). After removal of the epicutaneous induction patch erythemateous reaction was observed being clearly decreased 24 h later. According to the author, individual results were not given in tabulated form, as all skin examinations were negative, both at 24 and 48 h after challenge exposure.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified