Registration Dossier
Registration Dossier
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EC number: 700-316-5 | CAS number: 1155405-88-1
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1998-09-21 to 1998-10-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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:
- guinea pig maximisation test
Test material
- Reference substance name:
- Tri (hexyl, octyl, decyl) citrate
- IUPAC Name:
- Tri (hexyl, octyl, decyl) citrate
- Reference substance name:
- 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester
- IUPAC Name:
- 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester
- Reference substance name:
- -
- EC Number:
- 430-290-8
- EC Name:
- -
- IUPAC Name:
- 430-290-8
- Details on test material:
- - Name of test material (as cited in study report): Tri (hexyl, octyl, decyl) citrate
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature in a closed container
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 4 - 5 weeks
- Weight at study initiation: 301 - 311 g
- Housing: animals were kept in groups (max. group size 10 animals) in Terluran - cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Altromin 3122 maintenance diet for guinea pigs ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 1998-09-21 To: 1998-10-16
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % in induction exposures and challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % in induction exposures and challenge
- No. of animals per dose:
- 10 animals in the test group, 5 in control group
- Details on study design:
- RANGE FINDING TESTS: Four animals were topically treated with the test item. No signs of irritation were recorded after a contact period of 24 h. Therefore the maximum concentration was chosen for the inductions and the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 mL); 2nd exposure: epicutaneous for 48 hours
- Site: according to guideline
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with sodium lauryl sulphate (0.5 mL, 10% in vaseline) and day 7: dermal treatment
- Duration: 20 days
- Concentrations:
Induction, 1st stage:
Test group: Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline; injection 2: test item 100%; injection 3: test item 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Control group: Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline; injection 2: NaCL (0.9%); injection 3: NaCl (0.9%) 50% (v/v)in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Induction, 2nd stage:
Test group: 100% test item
Control group: 100% NaCl (0.9%)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 20
- Exposure period: 24 hours
- Test group: test item and NaCl (0.9%) as intraspecific control
- Control group: same as test group
- Site: left flanks for test substance, right flanks for NaCl
- Concentrations: 100%
- Evaluation: 24, 48 and 72 h after patch removal - Challenge controls:
- see above
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole (reliability check, not in parallel with the test)
Results and discussion
- Positive control results:
- 60% of the positive control animals showed sensitization reactions 24 and 48 hours after end of challenge treatement (positive cotnrol substance concentrations: 2% at induction I phase, 25% at induction II phase, 15% at challenge)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No other signs of toxicity observed, animals showed normal food intake and weight gain.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No other signs of toxicity observed, animals showed normal food intake and weight gain..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No other signs of toxicity observed, animals showed normal food intake and weight gain.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No other signs of toxicity observed, animals showed normal food intake and weight gain..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- None of the 10 animals of the test group showed allergic skin reactions until 72 hours after patch removal as compared to the intraspecific application of NaCl (0.9%) and to the animals of the control group. The sensitization rate after application of Tri (hexy, octy, decyl) citrate was 0%. Under the test contions described the test item showed no sensitizing properties.
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