Registration Dossier

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:
key study
Study period:
November 12th, 1984 - April 18th, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with acceptable restrictions.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 79(831/EWG, Annex V, Part B)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
, lack of details on test substance and lack of positive control data.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glyceride, C16-18 and C18 Mono- and Dihydroxy
- Physical state: white pellets of doughy consistence
- Analytical purity: no data
- Batch No.: Part 4026-3
- melting point: ca. 94 degree 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
- Age at study initiation: no data
- Weight at study initiation: mean: 312 g (test group) and 303 (control group)
- Housing: Makrolon Type IV, 5 animals per cage
- Diet (e.g. ad libitum): Altromin Diet 3032 DK, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 50-60
- Air changes (per hr): no data
- 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: 50%
challenge: 25 % in vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
Concentration / amount:
induction: 50%
challenge: 25 % in vaseline
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
3 preliminary tests were performed with 5 animals each:
For the intradermal induction a 1% concentration of test substance in vaseline induced sufficient skin irritation.
For the epidermal induction a 50% concentration of test substance in vaseline 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 25% concentration was found to be the maximum non-irritating concentrations.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 2nd induction: 48 h (epicutaneous exposure)
- Test groups: 20 animals, TS (intracutaneously: FCA alone (cranial application), TS in FCA, TS in vehicle, epicutaneously: 1 week after intradermal induction, occlusive conditions)
- Control group: 20, vehicle only
- Site: 1. induction: Interscapular region, 2nd induction on the same site as 1st induction
- Frequency of applications: 1st induction on day 0, 2nd induction on day 7
- Concentrations: 1% for intradermal induction, 50 % for topical induction

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the 2nd induction
- Exposure period: 24 hours
- Test groups: 20, TS
- Control group: 20, TS
- Site: right flank, occlusive conditions
- Concentrations: 25 % (0.2 g application volume)
- Evaluation (hr after challenge): 24 and 48 hours after exposure

Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

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

Any other information on results incl. tables

Individual results were not given in tabulated form, as all skin examination were negative, both at 24 and 48 hours after challenge exposure. None of the animals showed abnormalities in clinical observations and body weight gain.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information to guinea pig skin