Registration Dossier
Registration Dossier
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EC number: 932-019-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization study in guinea pigs is available for KGA. No signs of irritation were seen in any animals during the challenge phase.
Test material
- Reference substance name:
- 3,4,5,6-Tetrahydroxy-2-oxo-hexanoic acid
- IUPAC Name:
- 3,4,5,6-Tetrahydroxy-2-oxo-hexanoic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Age at study initiation: About 5 weeks
- Weight at study initiation: 340-399 grams
- Housing: The guinea pigs were housed in a Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 60-87%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: June 05, 1997 To: July 25, 1997
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Aqua pro Injectione
- Concentration / amount:
- 50%
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Aqua pro Injectione
- Concentration / amount:
- 50%
- No. of animals per dose:
- 10 in the negative control group; 20 in the test material group
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 1
- Site: Shoulder
- Frequency of applications: Intradermal injection on day 1 (50 g/L); Topical application on day 8 (100 g/L)
- Duration: 8 days
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 3
- Exposure period: 48 hours, 72 hours
- Test groups: 1
- Control group: 1
- Site: Shoulder
- Concentrations: 10 g/L
- Evaluation (hr after challenge): 72 hours - Challenge controls:
- Aqua pro injectione
- Positive control substance(s):
- yes
- Remarks:
- Aqua pro injectione
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: Weak sensitizer
- Conclusions:
- According to Magnusson and Kligman, the test material has been classified as a weak sensitizer, which corresponds to a sensitization rate of 0-8%.
- Executive summary:
This study examined the potential of the test substance to cause sensitization to skin. A group of 20 female guinea pigs were exposed to a concentration of 50% of test substance. 20 female guinea pigs were used as controls. The induction phase consisted of two intradermal injections followed by dermal application. Seven (7) days later, the animals were challenged by dermal application. No signs of irritation were seen in any animals during the challenge phase. The test substance is not sensitising to skin, but is considered to be a weak sensitizer according to Magnusson and Kligman.
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