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:
May 11th, 1998 - September 10th, 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance 555-43-1. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol tristearate
EC Number:
209-097-6
EC Name:
Glycerol tristearate
Cas Number:
555-43-1
Molecular formula:
C57H110O6
IUPAC Name:
propane-1,2,3-triyl trioctadecanoate
Details on test material:
- Name of test material (as cited in study report): Glycerol tristearate
- Physical state: white homogeneous powder
- Analytical purity: 98.0 area %
- Batch No.: 512014
- Stability: > 3 years
- Expiration date: not before 01/99
- Solubility in water: practically insoluble

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin-Hartley, Pirbright White Hsd/Poc:DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany.
- Age at study initiation: young adults
- Weight at study initiation: less than 500 g
- Housing: conventional in Type IV Makrolon cages, maximum 5 animals per cage
- Diet (e.g. ad libitum): Ssniff G 4 pellet diet, Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/ 3
- Humidity (%): 30 - 70 (temporary deviations were caused by cleaning the animal room)
- 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:
petrolatum
Concentration / amount:
50 % of test substance in vaseline for induction and challenge
(50% of the test substance was found to be the highest concentration which was good miscible in vaseline)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
50 % of test substance in vaseline for induction and challenge
(50% of the test substance was found to be the highest concentration which was good miscible in vaseline)
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
3 female animals, 10, 20, 30 and 50 % were applied topically to the flank under occlusive conditions for 6 hours.
The maximum non-irritant concentration of 50% was used for challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: On days 0, 7 and 14
- Test groups: 20, TS
- Control group: 10, vehicle
- Site: left flank
- Frequency of applications:
- Duration: 6 hours
- Concentrations: 50% test substance in vaseline

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28 (14 days after third induction)
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, TS
- Site: right flank
- Concentrations: 50% test substance in vaseline
- Evaluation (hr after challenge): 24 and 48 hours after test substance removal with corn oil.
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:
The sensitivity of the guinea pig strain was confirmed by a Buehler test performed from November 24th, 1997 - December 24th, 1997 with alpha-hexylcinnamaldehyde.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 % test substance in vaseline
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: 50 % test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 % test substance in vaseline
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: 50 % test substance in vaseline. 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:
50 % test substance in vaseline
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: 50 % test substance in vaseline. 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:
50 % test substance in vaseline
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: 50 % test substance in vaseline. 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
Conclusions:
In this study performed according to OECD guideline 406 (Buehler method) Glycerol Tristearate was not sensitising in guinea pigs.