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EC number: 287-824-6 | CAS number: 85586-21-6
Skin sensitisation
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:
- weight of evidence
- Study period:
- 02 Dec 1992 - 07 Jan 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study, tested with the source substance CAS 67762-38-3. According 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted before OECD guideline for LLNA was established.
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., Me esters
- EC Number:
- 267-015-4
- EC Name:
- Fatty acids, C16-18 and C18-unsatd., Me esters
- Cas Number:
- 67762-38-3
- Molecular formula:
- UVCB substance, not univocal molecular formula available
- IUPAC Name:
- Methyl (9E,12E,15E)-octadeca-9,12,15-trienoate methyl (9Z)-octadec-9-enoate methyl (9Z,12Z)-octadeca-9,12-dienoate methyl hexadecanoate methyl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Rübölfettsäuremethylester
- Physical state: clear liquid
- Analytical purity: 100%
- Batch Nr.: A 06097:92
- Expiration date of the batch: 23.10.1994
- Storage condition of test material: room temperature, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Substrain as given in report: Bor: DHPW (SPF)
- Source: Winkelmann Versuchstierzucht, Germany
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: 358 - 488 g (males), 301 - 424 g (females)
- Housing: groups of 5 animals in Makrolon type IV cages
- Diet: Ssniff-G diet for guinea pigs, ad libitum
- Water: ad libitum
- Acclimation period: 7 days for range finding pretest, 12 days for main test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- peanut oil
- Concentration / amount:
- - Induction, intradermal injection: 5% test item in peanut oil
- Induction, epidermal: 100% test item
- Challenge: 100% test item
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- - Induction, intradermal injection: 5% test item in peanut oil
- Induction, epidermal: 100% test item
- Challenge: 100% test item
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING PRETEST
- Intradermal injection: the test item was injected at a concentration of 5% in aqua ad inject. and Freund's complete adjuvant (FCA) in each of 2 animals; skin reaction was recorded after 48 h. Since no skin reaction was noticed, 5% was found to be suitable for intradermal injection.
- Epidermal application: the test item was applied undiluted onto the skin of each of the 2 animals under occlusive conditions; skin reaction was recorded after 48 h. Since no skin reaction was noticed, 100% was found to be suitable for epidermal application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction on day 1 and epidermal induction at day 8 (for 24 h)
- Test groups: 20 animals, treated with test item
- Control group: 20 animals treated with vehicle only
- Site: the scapular region of both sides
- Frequency of applications: once
- Duration: 3 weeks
- Concentrations: 5% dilution of the test substance in peanut oil was used for intradermal induction and 100% used for epidermal induction
- Pretreatment: skin was pretreated with sodium lauryl sulfate (SLS, 10% in vaseline) 24 h prior to epidermal induction
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 14 after epidermal induction (day 22)
- Exposure period: 24 h
- Test groups: 20 animals, treated with test item
- Control group: 20, treated with test item
- Site: one sheared flank
- Concentrations: 100%
- Evaluation (hr after challenge):24 and 48 h
SCORING
Scoring of skin findings was based on the Draize System - Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene and benzocaine
Results and discussion
- Positive control results:
- periodically tested, last test with acceptable level of response: October 1992
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:
- 20
- Clinical observations:
- none
- 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. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- 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: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- 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. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- 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: 20.0. Clinical observations: none.
Any other information on results incl. tables
Individual challenge readings:
Animal No. |
Sex |
Day 24 |
Day 25 |
Comments |
||||||
100% |
Vehicle |
100% |
Vehicle |
|||||||
Ery. |
Ed. |
Ery. |
Ed. |
Ery. |
Ed. |
Ery. |
Ed. |
|||
Control |
||||||||||
1 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
2 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
3 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
4 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
5 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
6 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
7 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
8 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
9 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
10 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
11 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
12 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
13 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
14 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
15 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
16 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
17 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
18 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
19 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
20 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
none |
Treated |
||||||||||
1 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
2 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
3 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
4 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
5 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
6 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
7 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
8 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
9 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
10 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
11 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
12 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
13 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
14 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
15 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
16 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
17 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
18 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
19 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
20 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Not sensitized |
The sensitization rate at 24 h and 48 h was 0%
No deaths occurred. No significant difference in body weight gain was observed between treated and control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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