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EC number: 293-170-2 | CAS number: 91052-13-0
Toxicological information
Skin sensitisation
Currently viewing:
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:
- 1 998
- 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
- Reference substance name:
- Glycerol tristearate
- EC Number:
- 209-097-6
- EC Name:
- Glycerol tristearate
- Cas Number:
- 555-43-1
- 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
Constituent 1
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.
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