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EC number: 947-919-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 01 Feb - 03 Apr 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The results of the reliability check were inconclusive.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- results of reliability check were inconclusive
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- results of reliability check were inconclusive
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler Test was performed prior to the amendment of Regulation (EC) No 1907/2006 in which the Local Lymph Node Assay is given as the first-choice in vivo study.
Test material
- Reference substance name:
- (Z)-octadec-9-enyl (Z)-docos-13-enoate
- EC Number:
- 241-654-9
- EC Name:
- (Z)-octadec-9-enyl (Z)-docos-13-enoate
- Cas Number:
- 17673-56-2
- Molecular formula:
- C40H76O2
- IUPAC Name:
- octadec-9-en-1-yl docos-13-enoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley Crl:(HA)BR
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: approximately 5 weeks
- Weight at study initiation: approximately 380 g
- Housing: in groups of 2-3 animals in Makrolon Type IV cages (EBECO) with standard softwood bedding (ARWI-Center, Essen, Germany); bedding chaged twice weekly
- Diet: pelleted Altromin Maintenance Diet 3022 (Fa. Altromin, Lage, Germany), ad libitum. Carrots optionally added.
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 45-70
- Air changes (per hr): 100 m³
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 7 Feb - 3 Apr 1995
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 70%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 60%
- No. of animals per dose:
- 10 (control group), 20 (treatment group)
- Details on study design:
- RANGE FINDING TESTS:
Irritation test: 0.5 mL of the test substance was applied topically to the shaved skin of 3 guinea pigs, successively. A concentration of 12.5, 25, 50 and 100 % was applied to the left flank and 30, 50 and 70% concentration to the right flank. The exposure was terminated after 6 hours by removing the plaster and cleaning the skin with 20% propylene glycol. The severity of erythema and oedema was assessed 24 and 48 h after exposure. The undiluted substance caused weak, confluent erythema in 1/3 animals at the 24 and 48 hour reading time point. The 70% solution was the lowest concentration to induce minimal irritation; causing weak, confluent erythema in 1/3 animals 24 hours after exposure. This effect had cleared within 48 hours.
Challenge test: the maximum non-irritating concentration was tested one week before the challenge in the main study by applying 0.5 mL of 30, 50 and 70% solution to the right flank of 5 animals in the control group under occlusive conditions. After 6 hours, the plaster was removed and the site cleaned with 20% propylene glycol. 24 and 48 hours after the exposure ended, the skin irritating effects were assessed. None of the concentrations caused skin irritation. 60% was selected to be the challenge dose.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in peanut oil
- Control group: peanut oil
- Site: left cranial shaved flanks
- Frequency of applications: once weekly
- Duration: Day 1-14
- Concentrations: 70%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test substance in peanut oil
- Control group: test substance in peanut oil
- Site: left and right caudal flanks
- Concentrations: 60%
- Evaluation (hr after challenge): 24, 48 and 72 h - Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- A reliability check is carried out at regular intervals with alpha-hexyl cinnamic aldehyde to check the sensitivity of the test system and the reliability of the experimental methods used by the test laboratory. An independent study was performed in October-December 1994 (report No. R 9400844), according to the Buehler method. During the first challenge with 25% alpha-hexyl cinnamic aldehyde, a sensitisation reaction was induced in 25% (5/20) of the Dunkin Hartley guinea pigs, while the second challenge did not lead to conclusive sensitisation reactions. In the negative control group, the first challenge induced sensitisation in 20% (2/10) of the animals, and the second challenge did not caused any sensitisation reactions. The 50% solution in peanut oil that was used for the topical inductions, caused weak to moderate skin irritation. A 25% solution was applied in the first challenge, while a 25% solution was applied to the left flank and 15, 20 and 25% solutions were applied to the right flank during the second challenge. As 20% of the animals in the negative control group reacted, the results of the reliability check are inconclusive.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1/10 animals showed slight, patchy erythema on the right flank only
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1/10 animals showed slight, patchy erythema on the left flank only
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- 2/20 animals showed slight, patchy erythema on the left flank only
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: positive control was tested in an independent study
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: positive control was tested in an independent study
Any other information on results incl. tables
Skin rections, induction phases
The 3rd induction with a 70% solution caused slight skin irritation in 2/20 treatment animals.
Skin reactions, challenge phase
At the first reading, 1/10 control animals had slight, patchy erythema on the challenge site on the left flank. 1/10 in the control group had slight, patchy erythema on the right flank at the second reading, while 2/20 treatment animals had slight, patchy erythema on the left flank at the second reading. All skin irritation effects had cleared within 72 hours after exposure ended.
Table 1: Skin reactions 24, 48 and 72 hours after challenge
|
24 hours |
48 hours |
72 hours |
|||
group (# of animals) flank |
control (10) l/r |
treatment (20) l/r |
control (10) l/r |
treatment (20) l/r |
control (10) l/r |
treatment (20) l/r |
none |
10/9 |
20/20 |
9/10 |
18/20 |
10/10 |
20/20 |
slight |
0/1 |
0/0 |
1/0 |
2/0 |
0/0 |
0/0 |
weak |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
moderate |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
strong |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
l: left flank, induction site and challenge site
r: right flank, challenge site
Mortality and body weight
There was no mortality during the study period and the animals in the treatment group showed a similar gain in body weight compared with the control group.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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