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EC number: 947-004-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- When the study was conducted the LLNA method was not available.
Test material
- Reference substance name:
- Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters
- EC Number:
- 947-004-7
- Molecular formula:
- C28H56O6 - C29H58O6 - C30H60O6
- IUPAC Name:
- Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters
- Test material form:
- liquid
- Details on test material:
- product
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: "Padre Antonio" Mariano Comense (CO), Italy
- Age at study initiation: no data
- Weight at study initiation: 200 - 300 g
- Housing: in groups of ten in transparent polycarbonate cages (dimensions: 590x385x200 mm)
- Diet (e.g. ad libitum): standard complete pellet diet ad libitum by the company MUCEDOLA
- Water (e.g. ad libitum): filtered water from an automatic watering system
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C+- 2 °C
- Humidity (%): 55 % +- 15 %
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-06-02 To: 1992-06-26
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % (undiluted)
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
Skin preparation:
24 hours before testing, fur was removed by shaiving a 50 cm² wide area on the back of the animals.
A. INDUCTION EXPOSURE (treated and control groups)
Day 0:
- No. of exposures: 3 pairs of 0.1 ml intradermal injections were made in the subscapolar region of each animal, on each side of the midline.
1) Freud complete adjuvant (FCA) in distilled water (proportions 1:1)
2) Test material in distilled water (control distilled water instead)
3) Test material in distilled water and FCA (proportions 1:1)
Day 7:
0.5 ml test material/animal was applied by intradermal injection and held in place with an occlusive patch. The application was made on an area localized caudally to the area of injection for a period of 48 hours (control distilled water instead).
B. CHALLENGE EXPOSURE (treated and control groups)
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: 24 h
- Test groups: 0.5 mL test substance occlusive patch (right flank)
- Control group: 0.5 mL distilled water (left flank)
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 h - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
Any other information on results incl. tables
Signs of irritation during induction:
NONE
Evidence of sensitisation of each challenge concentration:
0/20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- During the study no signs of erythema and/or oedema were observed in treated and control animals. The test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters was considered to be not skin-sensitising in guinea pigs.
- Executive summary:
An allergic sensitisation test was carried out on test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters according to OECD Guideline 406.
30 guinea pigs were used in the test, 10 as a control and 20 were treated with the test material. The test consisted of 2 phases, an induction phase and a challenge phase. During the induction phase the group of 20 treated guinea pigs were first treated with 3 double intradermal injections as follows:
1st Freud complete adjuvant (FCA) in distilled water (proportions 1:1)
2nd Test material in distilled water
3rd Test material in distilled water and FCA (proportions 1:1)
The 10 control animals received the same pairs of injections but in the 2nd injection only distilled water was used.
After 7 days of intradermal injections the test material (at a dose of 0.5 ml/animal) was applied for a period of 48 hours. The same treatment was used on the 10 control guinea pigs using only distilled water.
21 days after the beginning of treatment a challenge phase was performed by applying 0.5 ml of test material on the left side, and distilled water on the right side on the bandage was left on for 24 hours.
24, 48 and 72 hours after the beginning of this phase the animals tested and the control animals were observed. No signs of erythema or oedema were observed in any of the animals.
Therefore the test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters can be considered as non sensitizing.
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