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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:
key study
Study period:
March 23rd, 1993 - April 30th, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with acceptable restrictions Lack of positive control data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
, lack of positive control data
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Heptanoic Acid Trigylceride (Glycerol Triheptanoate)
- Physical state: homogeneous, pale yellow liquid
- Analytical purity: 97.2 area %
- Batch No.: 209052
- Water solubility: not soluble
- Stability: > 1 year
- Expiry date: Oktober 1993 at the earliest

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley, Pirbright White Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 401 g +/- 29 g
- Housing: conventional, 5 animals per cage in Makrolon Type IV
- Diet (e.g. ad libitum): Ssniff G4 diet, Soest, Germany
- Water (e.g. ad libitum): tap water, Haltern, Germany
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 % unchanged test substance for induction and challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 % unchanged test substance for induction and challenge
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
25, 50, 75 and 100 % (w/w) of the test substance in corn oil were tested in 4 animals via topical application under occlusive conditions.
Exposure duration was 6 hours.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, without TS
- Site: left flank
- Frequency of applications: on days 0, 7 and 14
- Duration: 6 h
- Concentrations: 100 % of the test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28 (14 days after the third induction)
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, TS
- Site: right flank
- Concentrations: 100 % of the test substance
- Evaluation (hr after challenge): 6, 24, 48 and 72 hours after application of the test substance.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no abnormalities
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no abnormalities
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormalities
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormalities
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information In a study performed according to OECD guideline 406 (Buehler), Glycerol Triheptanoate was not sensitising to the skin.